NIH Women's Health Roundtable Series: Maternal Mental Health Research: Elevating Women's Voices to Improve Maternal Mental Health

Transcript

TAMARA LEWIS JOHNSON: On behalf of the National Institute of Mental Health's Office of Disparities Research and Workforce Diversity and the National Institutes of Health Office of Research on Women's Health, good afternoon and welcome to the 2024 NIH Women's Health Roundtable on Maternal Mental Health Research: Elevating Women's Voices to Improve Pregnancy and Postpartum Health.

I am Tamara Lewis Johnson, the Program Director for Women's Health Research at the National Institute of Mental Health, and allow me to introduce Dr. Melissa Simon, the George H. Gardner Professor of Clinical Gynecology and the Director of the Institute for Public Health and Medicine's Center for Health Equity Transformation at Northwestern University. She will be the moderator for today's roundtable.

MELISSA SIMON: Thank you so much for that introduction, Ms. Lewis Johnson.

The NIH Women's Mental Health Roundtable on Maternal Mental Health Research is an event co-hosted by the National Institute of Mental Health and the Office of Disparities Research and Workforce Diversity Webinar Series. It focuses on mental health equity research topics and the NIH Women's Health Roundtable Series, which highlights important women's health topics such as maternal mental health as part of the White House Women's Health Research Initiative.

We are in a very exciting time right now for women's health research with that White House initiative on women's health research and also initiatives across NIH, such as the IMPROVE initiative. This is a really exciting time, and I'm so privileged and glad to be here as part of this important discussion today.

In today's roundtable and in the work more broadly, gendered language is often used when discussing pregnancy and pregnancy-related health. NIH supports, as much as practical and possible, the use of de-gendered language for maximal inclusivity, and we've included some of those terms like pregnancy-related, pregnant, and birthing people where appropriate. When we talk about women's health, we mean cisgender women as well as transgender women and others who were assigned female at birth.

This NIH Women's Health Roundtable Series was developed as a recommended action in response to the Presidential Memorandum to bring attention to priority topics within the Department of Health and Human Services and to disseminate information on federally supported research areas.

So, the goals of today's roundtable are to spotlight high-priority areas of research related to mental health during pregnancy and the postpartum period, up to one year following parturition or childbirth and then to share information on how NIMH-supported biomedical and behavioral science paves the way for innovative therapeutics and provides evidence to advance screening, diagnostics, and preventive and treatment interventions to improve women's mental health during the perinatal period, and to inform the public about how pregnancy-related mental health research is important to reduce the burden of mental illnesses that contribute to pregnancy-related morbidity and mortality, and to identify and explore gaps in areas critical to women's research outlined within EO 14120 and the NIH-wide Strategic Plan for Research on the Health of Women.

To read more about what the Office of Research on Women's Health and the National Institute of Mental Health does with respect to maternal mental health and women's health research in general, please refer to the website.

I want to get to our very packed agenda today. I am going to truncate these amazing speakers' bio sketches and bios -- they are absolutely amazing -- and they are on the link in the chat as well as the agenda with respect to all the bios in the agenda. You will find that we have an extremely exciting day ahead. So, I want to introduce our speakers.

The first two speakers of the beginning part of our roundtable are Doctors Vivian Ota Wang, she is the Deputy Director of the NIH Office of Research on Women's Health, and then Dr. Samantha Meltzer-Brody, who is a clinical researcher and the Assad Meymandi Distinguished Professor and Chair of the Department of Psychiatry at the University of North Carolina Chapel Hill. Her keynote address is entitled From Biology to Breakthrough: The Story of Brexanolone and Zuranolone.

So, without further ado, I am going to pass the baton to Dr. Vivian Ota Wang. Thank you.

VIVIAN OTA WANG: Thank you very much, and welcome, everyone. Good afternoon. What I'm going to do is to do a brush stroke of really trying to talk about women's health to set up the stage for this afternoon. Let me go ahead and share my screen and my presentation. So here we go.

So what I'm actually going to be talking about is a plethora of topics, including what does it mean to have whole-person health and women's health, and why sex and gender matter, and then drilling down on maternal mental health, and then giving you a snapshot view of what the NIH Office of Research on Women's Health is, what we're doing, and how we are really working with the White House Women's Health Research Initiative. And then, really, the next steps of the implications of all of this work and you.

So, as we begin, I want to think about when we work with underrepresented, understudied, and underreported groups and individuals. I'm challenging you to pay attention to what you see versus what you don't, who you include versus who you ignore, when you care and when you don't, and who you are versus what others think you should be, because what you see depends on where you stand.

And so, part of that is trying to figure out and answer the question, "Does sex matter?" Of course, it matters. It's a very important part of a basic human condition that should be considered for researchers and clinicians when designing and analyzing our results because, as we know, women -- Cis or Trans -- are really underrepresented in our research. Just to highlight on this slide, we do know at least twice as many women suffer depression than men in the United States, and it really is the leading cause at this point of disability in women, and that in terms of animal studies, fewer than half of animal studies for anxiety and depression use female lab animals, although we know the reality is that these conditions affect women twice as much as men.

And so, what we need to do if we're going to really examine this thoughtfully is understand what the health of women across their life course is, and it's a combination of the bottom of these biological perspectives, whether we're looking at genomics, molecular, or physiological levels. We’re looking at the top, or turquoise level, we are looking at the context of women, really determining and identifying the social and psychological determinants of their health. In the middle, really taking a point of view of the entire life course because women's health changes over time, whether it's pre-pregnancy for those who are going through maternal issues, as well as childhood, adolescence, or adulthood. And then we have to take into account, on the left, sex, gender, and the way they interact with epigenomic factors, and always keeping in mind that these are constantly interacting with one another. Because what we do know on a practical level is that there are differences in disease prevalence. As you can see on the bar graph on the left, you can see a ballooning effect for females really beginning in the teens, all the way through midlife, with an increase in certain conditions, specifically looking at musculoskeletal conditions, other non-communicable conditions, as well as the increase in mental disorders and substance use. If you look on the right, we know that women quantitatively live longer than men, but those differences in years mean that they also live with disability as well. You can see illustrated on the right that same ballooning effect as compared to men, really illustrating that women have a very different experience with health and disease.

And that's really because there are a lot of factors that go into that. When we look at broader societal levers that include environmental exposures, access to care, age, gender, and people's attitudes about all of these particular issues.

Also, I just want to give you a snapshot on this busy slide of some of the policy implications and what this has meant for women's health research. We can look at the far left, where we know in 1977, the FDA had a general guideline that excluded women of childbearing potential from research. We know that in 1986, NIH had a policy that encouraged inclusion of women in clinical trials, and it was not until 1994 that NIH promulgated guidelines for inclusion of women and minorities in clinical research.

If we can zip all the way to 2016, I’ll talk a little bit more. There was a specific effort for NIH-funded research to include sex as a biological variable. We do know three years later, there was an expansion of the NIH policy guidelines that not only included women and minorities in clinical research, but also included individuals of all ages and brought age into effect. Then I’m going to talk at the end of my presentation, really looking at some of the exciting things going on, as Dr. Simon mentioned earlier, about how the Executive Order 14120 has really accelerated a lot of the work that the Office of Research on Women's Health has been doing for the past 30 years.

I also want to bring attention to the fact that we’re talking about biology, and I want to challenge us to think about using a more systems biology approach. Here is a nice example of a human disease network, where it really nicely illustrates that, although we have canonical diseases that we can talk in terms of retinitis pigmentosa, coronary artery disease, boy are they touching a lot of the different other diseases. It really becomes a systems approach. I just had to give you this color -- someone colorized it because I think it’s prettier.

Here’s an example of a systems approach to the health of women, it’s an example of menopause. Where if we think about menopause, we're looking at a system that includes metabolic dysfunction, mental health issues related to anxiety, depression, substance use, pelvic floor disorders, bone health and osteoporosis, cardiovascular disease, frailty and sarcopenia, brain health, and dementia across a lot of different ways that are part of the lived experience of woman including physical activity, sleep, nutrition, and what's going on with their microbiome, which truly affect as an interaction the quality of life of women.

Because what we do know is that women and men follow different paths to disease and health. We may actually have started point that may appear to be similar, but because of all these factors I’ve brought up before we have a very different path and endpoint.

So, what this basically means is that we are having to take into account the worked that we do not only the cellular aspects of the phenomena but looking at the system of the entire woman. And really looking how differences of manifestation of diseases and within that the culture of sex and gender assumptions and how they affect research and clinical practice, and basic -- the culmination the environment because these can affect as summative phenomena, the nature and interactions, and practices of not only researchers and research participants, but also the clinicians and the community and institutions they reside.

So, I wanted to really talk about two particular points in a woman's life that are sentinel. One is the general midlife period where it's a pivotal time for chronic diseases really starting to appear in a woman's life among women. And this example is using menopause where there is a significantly higher cardiovascular risk of between premenopausal and postmenopausal women and really just highlights the critical issue that we need to address midlife women's health for preventing and diagnosing and treatment issues related to women.

But what I want to do with the remaining part of my presentation is focusing on pregnancy as a state some women experience during their lifespan, and that in fact pregnancy is also type of stress test on a woman’s health. As you can see from this illustration, it can really start from adolescence where there may be peaks of depression and understanding not only the biological but social determinants of health, as we can see through pregnancy, they can actually present themselves as preeclampsia or higher blood pressure, gestational diabetes; and that may persist with hypertension, Type 2 diabetes, cardiovascular disease and depression.

So, what I want to do is just, I'll give a backdrop of how we understand mental health of women, and what we actually know is that neurological and mental disorders are diagnosed more frequently in females. That's about, I would say, about 19 or nearly 20%. In sheer numbers, it's about 45 million U.S. adults living with mental disorders. We know that there's a higher prevalence of women being diagnosed than men. And that, in fact, it begins in adolescence and persists throughout the remainder of the lifespan of through adulthood. I also want to really bring to your attention that these incidences are also higher in other general conditions, mental disorders, including anxiety, behavioral disorders, mood disorders, and substance use.

So, as you can see in the illustration on the right, in the elliptical of the peach is really to illustrate that specifically neurological disorders, mental disorders, and substance use disorders tend to accelerate and persist for women compared to men. This is really to bring to your attention the issue of maternal mental health and depression. And what we know is up to one in five of those who are pregnant and in postpartum depression will suffer a maternal mental health disorder like postpartum depression. Importantly, I think we need to keep in mind that less than 15% actually receive treatment. We know that maternal depression occurs as frequently during the pregnancy as it does during the postpartum, and that over 600,000 women will suffer from maternal mental health disorder every year in the United States. Importantly, if we put the overlay of the racialized experience on women, we know that the rates of depression more than double in the Black population, really due to the cumulative effects of stress, which some people call weathering. But this is really Bruce McEwen's work on allostatic load related to stress. So, something important to remember.

As we talk about depression -- oops, sorry, I just want to highlight that it really is a complicated phenomenon going from the bottom up that is related to immune signatures and how our body responds to it. It's also related to how our brain is actually affected by it, not only in terms of biochemistry but also the anatomy related to abnormalities of the brain and neuroplasticity. What is the beacon of this is really understanding that the symptoms are twice to be more likely diagnosed in women than men, and that, in fact, women experience a higher symptom severity as well as atypical features, not only somatically but in terms of cognitive and affective systems.

And because of that, it also is important to remember it actually has a higher rate of comorbidity with anxiety.

So, when we talk about anxiety, I think not only do we have to think about anxiety related to maternal mental health but to realize that through childhood, the prevalence of anxiety is similar for boys and girls. But at puberty, the sex differences start to distinguish themselves, and part of it at that time for girls, there is a remodeling that is going on with their brains, which persists through adulthood, perinatal and menopause.

And then the last, let’s look at the issue of postpartum psychosis and risk factors, really just bring to your attention that it's something we need to take care of and pay attention to. And that some of the phenomenon that we are experiencing and having to pay attention to are really related to intimate partner violence, that it has increased depression, anxiety, and post-traumatic stress disorder.

What we need to pay attention to as we start to look at this phenomenon, we have to ensure research to ensure that it's included in the preclinical studies, that we include it not only in human, but animal studies as well, and that it will always have implications for health policy.

And lastly -- I’m almost done. Dr. Simon. I do see you there -- is really to illustrate that the Office of Research on Women's Health is really working along the work that is mapped out in the strategic plan to ensure cross-functionality, partnerships, and innovation across all the NIH institutes to ensure that we're driving synergistic research priorities across all of the different 27 institute centers, and offices.

And lastly, really just to once again bring to everyone's attention that there was a launch of a White House initiative on women's health research as a way to accelerate the existing work that the Office of Research on Women's Health and NIH has really been doing for the past 30 years. It is a comprehensive set of executive actions that are really wanting to strengthen research and data standards for women's health, prioritizing the way that grant-making and awards are done at NIH and across the government to advance women's health research. We’re really want to ensure that there is a backbone in infrastructure related to statutory, regulatory, and budgets as a way of addressing research gaps associated specifically for women's midlife and later years.

It's US government partners of 11 federal agencies you see on the slide. And it's really just quite an exciting time, not only to forward audacious and innovative science but also to work across the federal government.

And I'm just going to skip that, and you have that in your slides, but really to show we have been very active in this. Really looking at the next year's funding to look at new interdisciplinary women's health research and expanding into the innovation space of small business SBIR/STTR investments and really looking to expand and create a comprehensive way of understanding menopause. And creating an easier way for all of you, as researchers, to figure out where the funding opportunities are.

We have a front door here located at the Office of Research on Women's Health, where you can actually come and identify all of the NIH women's health funding opportunities across all the institutes in one place.

I wanted to bring up this Notice of Special Interest, which I think has been an incredibly important and exciting way that NIH has expanded funding pathways for women's health research into 175 different priority topics. What it’s basically done is put a rider or hook into all parent research grants. And that includes research grants, career development grants, fellowships, and small business. So as can you see it has received support from all 30 participating NIH centers, institutes, and offices, and it has truly expanded the way all of you as researchers can actually try to get funding for your work.

MELISSA SIMON: Okay, thank you so much, Dr. Ota Wang. We have to transition.

VIVIAN OTA WANG: There we go!

MELISSA SIMON: Okay. Dr. Meltzer-Brody.

SAMANTHA MELTZER-BRODY: Yes, I am here, and I'm going to share my slides. Okay, okay, let's see. Hmm, let's get this up. All right. Can you see that? Okay.

MELISSA SIMON: Yes, perfect.

SAMANTHA MELTZER-BRODY: Great. Okay. So, it's a pleasure to be here today. And I was honored to be asked to share the story of the development of neurosteroid therapeutics as an innovative, rapidly acting treatment for postpartum depression. So, thank you for this honor today.

I want to acknowledge my disclosures: NIH funding, PCORI funding, sponsored research grants to UNC from Sage Therapeutics, Electromedical Products, and Sirtsei Pharmaceuticals all for clinical trials. I also serve on two different scientific advisory boards, and I'm a clinical advisor and professional corporation owner for a digital health company.

And so today, I'm going to talk about perinatal depression, just to get us all up to speed on the same page with prevalence and symptoms. Talk about the pathophysiology, mention the genetic signature of the Mom Genes Study that we've been working on, and then talk about how precision psychiatry is applied to the perinatal period and the work in novel treatments: Brexanolone and Zuranolone.

I want to acknowledge upfront that everything that I'll be talking about today reflects team science. All of this reflects a wonderful team of collaborators, and this work crosses academia, government, industry, and beyond, and the altruism of our patients who agree to participate in studies and share of their time and participate in this kind of science.

So, I want to acknowledge my enormous gratitude to be part of this very large team of people to try and make things better.

So, my work has taken me across the globe. This is a picture from Malawi. And I've always loved working with perinatal women and other pregnant people because it is such a profound time. I have the opportunity to return to Malawi very soon, where UNC has a program, and it really is always such an enormous privilege, both here in North Carolina and wherever else to participate at this really transformative and profound time in a person's life.

You'll hear the words perinatal depression, including all of pregnancy. If we look at postpartum depression or onset occurring in the late third trimester and into the postpartum period, then we see that the prevalence is 10 to 15% in the general population, occurring in reproductive age women and other people during pregnancy or after childbirth.

The underlying cause is unknown and is likely multifactorial. There's been all kinds of hypotheses, including inflammatory signaling, fluctuations in perinatal hormones, dysregulation of stress pathways, including the hypothalamic-pituitary-adrenal axis, GABA signaling dysfunction, and from work our team has done, it's more heritable than non-perinatal depression. So, you see that in perinatal people, you have it more heritable, up to 54%, compared to non-perinatal depression occurring outside of this window.

We know that postpartum depression is debilitating and a broad range of clinical symptoms, including low mood, decreased interest, or anhedonia, being unable to enjoy the baby, and lots of co-occurring anxiety, ruminating thoughts, vigilance, or hypervigilance. For example, being unable to sleep even when the baby is sleeping. This can interfere with the mother-baby relationship. You can have hopelessness, feeling completely overwhelmed, and most seriously, thoughts of harm to self, including frank suicidal ideation. And untreated postpartum depression can result in significant adverse consequences for the child and family. We know that maternal suicide remains one of the greatest causes of maternal death postpartum. We know that the disruption of a mom who is not doing well leads to enormous stress for all involved, and there are adverse outcomes for the baby's development over time if untreated.

Our team at UNC looked at the Perinatal Depression Treatment Cascade. This was published in 2016 in the Journal of Clinical Psychiatry. What I think this shows us is that there's still an enormous need for intervention. Of all women that suffer with depression during the perinatal period, whether it's antenatal in the lighter gray, postpartum in the black. If you look at the prevalence by those who are diagnosed, by those who receive some form of treatment, by those who receive what we would define as adequate treatment leading to remission, we see a marked falloff. This certainly speaks to the fact that we have a lot of work yet to do. I think we're doing much better with screening, but we really need to figure out how we're ensuring that people are getting adequate treatment that ideally leads to remission. There's quite a bit of work to do, as you can see from these graphs.

We were able, in 2011, to start a specialized perinatal psychiatry inpatient unit, and we were the first one in the United States, although we were 60 years after the mother-baby units in the UK and around many other parts of the world. There are other mother-baby units in the United States. I don't think, in any of the US-based ones, does the baby room in a well-baby nursery setting, as you see internationally.

However, we've worked really hard to provide a home-like atmosphere and protected sleep times. We have three to five patients, depending on how we swing doors for the unit, and this has been an outstanding place to conduct novel research protocols.

And so, I wish there was a specialized unit, at least regionally, because really, for pregnant and postpartum people, you need a specialized unit to provide care, and particularly if you want the baby to come visit, and our babies, the mothers have their babies come and visit -- they just cannot stay on the unit unsupervised.

I want to call your attention to the progesterone to allopregnanolone pathway. During pregnancy, levels of estrogen and progesterone go very high, and at the time of delivery, they rapidly fall. That happens in all women and other pregnant people that give birth. It's normal physiology, and progesterone is converted -- breakdown product -- to allopregnanolone, which is a neuroactive steroid that crosses the blood-brain barrier.

There are multiple hypotheses about the pathophysiology, and I would say that there is not one form of postpartum depression. I often say there's not one form of breast cancer. You can have hormone receptor-positive or negative breast cancer that leads you to very different types of treatment.

There's not going to be one type of postpartum depression either. And so, some of the hypotheses include endocrine mechanisms. So, you see here, at the top of sort of my left on the screen, is looking at the 1st trimester through 3rd trimester and then postpartum, at the time of childbirth, or parturition, you see the levels of estrogen and progesterone going very high -- the highest levels you see in a woman's life -- and then dropping precipitously postpartum. You will see that some percentages of women are going to be very susceptible to this rising and falling of hormones. Not the absolute rising and falling, but just susceptible to the fact that you have the rise and fall.

You also can have epigenetic mechanisms, Estradiol, or otherwise, synaptic transmission mechanisms, alterations in monoamines, and other neurotransmitters. Neural network mechanisms -- there's a literature on imaging studies that have demonstrated altered activity in the amygdala, prefrontal cortex, cingulate cortex, and the insula. Inflammatory mechanisms or altered levels of immune system factors. Neurosteroid mechanisms, altered levels of allopregnanolone and dysfunction, neuroactive steroid signaling, and stress mechanisms. Dysfunction of the HPA axis in women with PPD. So, all of these hypotheses have data around them, and one imagines that in any individual person, there will be contributions that may be more powerful and contribute to why one person develops postpartum depression versus someone else.

In 2010, we started a consortium to start understanding the genetic cause of this, and it brought together people from all over the world. That led to a study eventually, currently named Mom Genes. It started off as the PAT Consortium, moved to Postpartum Depression Act with a smartphone app -- the iPhone, and then Android phone -- and then Mom Genes Fight Postpartum Depression.

This study, which had been really led by Jerry Guintivano -- just to say who came into UNC as a postdoc, and now just has his 1st R01 -- is a geneticist doing psychiatric genetics in the space and has done really fantastic work that we sought to look at a meta-analysis of genome-wide association studies. And the results that came from this global effort to collect DNA samples was published in the American Journal included 70,000 people and showed the 1st genetic risk factors. It was the 1st large-scale genomic interrogation and allowed us to explore the genetic relationship of postpartum depression with other psychiatric traits.

It importantly identified the genetic risk for postpartum depression compared to major depressive disorder, bipolar disorder, insomnia, and other psychiatric disorders. And what the paper showed was the genetic variance was enriched for specific cell types, most notably GABAergic inhibitory neurons in the thalamus and hypothalamus, and there were specific differences noted between postpartum depression and major depression outside of that.

This study was not quite at the level of genome-wide significance. It was at 10 to the minus 7, not the magic 10 to the minus 8, and, like most of the GWAS papers initially, have results show that you need more sample sizes. And we are working on larger sample sizes. We're working on that now.

But one of the most interesting things is that the signal looking at the inhibitory neurons. And if you look at the postpartum depression column compared to the major depressive column and the top bar, looking at inhibitory neurons in the thalamus, you see enrichment in postpartum depression versus major depression, which is very interesting because the GABAergic system is an inhibitory system, and that is part of the underlying hypothesis of how Brexanolone and Zuranolone work.

So, in my career, I have always found it frustrating that the SSRIs, which have been around for 30-plus years, can take months to work -- weeks to months to work. And when you have someone who is suffering from depression, there's been a great need for rapidly acting treatments. That is always even most worrisome in the postpartum population, where you have a new baby, you have the mother, and the crisis that ensues when the mother is not doing well is really profound. And this critical period for both mother-infant attachment and bonding -- the fact that you can have really adverse outcomes in many ways -- has always been a motivation. How can we improve the care? How can we intervene more quickly to ensure better outcomes for all involved?

And we had the privilege to be involved in the clinical trials for Brexanolone, which was the first drug FDA-approved in 2019, and it is an IV drug. It's expensive. It requires being in a medically supervised setting. And there's now the oral drug Zuranolone. And we'll have a chance to talk about this more. So allopregnanolone, the proprietary formulation is Brexanolone, and Zuranolone is similar but the oral drug. But it is not allopregnanolone; it's modified a bit. They are the best-studied neuroactive steroids in postpartum depression and have been studied in major depression. But I want to just call attention to the fact there's other neuroactive steroids under investigation. Pregnenolone and Ganaxolone have been investigated for psychiatric and other medical conditions, including neurocognitive disorders, substance use disorders, stress disorders, and seizure disorders. So, it's an interesting space to see if this class of drug can have efficacy in a number of disorders.

If we talk about Brexanolone, as I mentioned, it's a proprietary formulation of the naturally occurring endogenous neurosteroid allopregnanolone, which I told you earlier, is the neuroactive metabolite of progesterone. This has been developed by Sage Therapeutics, and it was approved as the first FDA-approved drug for postpartum depression in 2019. It is a 60-hour infusion that is administered continuously up to at least 60 micrograms per kilogram per hour, or up to 90. The major side effect is sedation, and we performed the first open-label studies at UNC that led to the phase 2 and phase 3 studies.

The rationale for why to study this is because it's a positive allosteric modulator of GABA, and GABAergic hypofunction has been associated with postpartum depression. Because Brexanolone was a positive allosteric modulator, it was thought it may have therapeutic potential. Note that this drug binds to both intra- and extrasynaptic receptors, which makes it different than other GABAergic drugs.

The phase 3 studies were published in The Lancet in 2018, and I'll show you the data here that was published in that journal article. Women with postpartum depression who had severe symptoms -- a Hamilton Depression Score of, in 2 of the 3 studies, greater than or equal to 26, so quite depressed. There was one study that had more moderate Hamilton Depression Scores of 20 to 25. People were randomized to receive placebo versus Brexanolone 90 versus Brexanolone 60. They had the infusion for 60 hours and then were followed out to day 30 in all of the clinical trials.

The primary and secondary endpoints at the hour 60 were the change in baseline from the Hamilton score, and Brexanolone achieved a significantly greater reduction in least-squares mean that was clinically and statistically significant. So, looking at the 90, the subjects showed improved response with active drug versus placebo, also on the clinical global impression scale.

And what's most striking about the study's use and the work that we've seen subsequently is this rapid onset of action. At hour 12 of the infusion, you start seeing a marked affective state change, and even with the very first patient in the first open-label study, where we went into this with really low expectations of if you give allopregnanolone -- in this case, this proprietary formulation, will you see any signal at all? And we really went into it with low expectations, but thought it was worth doing based on the literature to date and some of the hypothesis around neuroactive steroids and potentially having an effect.

And the dramatic change in affective state from someone who was profoundly depressed, withdrawn, not eating, not interacting to 12 hours later, starting to brighten up to a day later, having an affective state change, wanting to eat, wanting to interact differently, was really amazing. And that formed the basis, after four open-label patients, for the phase 2 and phase 3 studies. The initial protocol developed in the open-label study was kept throughout the clinical trials, and certainly, a 60-hour IV infusion is not convenient, but we are able to care for patients and continue to have a clinical program. And it has been really amazing to see the rapid response. And so, this is the data over time, showing the sustained response. The initial response at the hour 60 mark, and then sustained at day 7 and through day 30 with active drug being more powerful.

The primary adverse reaction is sedation, and that is something that certainly with the IV drug has to be closely monitored. Hence, the treatment in a medically supervised setting, and then this lists the other side effects. But the primary issue is sedation and/or sleepiness.

So, the limitations from the clinical trials where it was uncertain if the results outside of the clinical trials would be relevant in more moderate patients. What would happen when you try to take the sort of setting of a clinical trial and go broader in a population of perinatal women? And what happened after 30 days? So, we saw treatment with Brexanolone -- a 60-hour infusion -- treatment response maintained for 30 days. What would happen after that?

And this was a paper our group published. The first author is my terrific colleague, Dr. Riah Patterson, who is the medical director of our perinatal psychiatry inpatient unit. And with our team, we looked at our clinical Brexanolone program that began after the drug was approved. Our unit is a national referral center for patients that seek care. What would we see at this point? And there were 16 patients who received a Brexanolone infusion starting in the fall of 2019 through the end of 2020, and what we saw was that they continued to have sustained response. Most of the patients did well, with the caveat that a number of them did receive oral antidepressants being prescribed after they had finished the infusion. But all of these patients had a significant treatment response initially with the Brexanolone infusion, and the overwhelming majority were looking very good, being followed up over time.

Zuranolone is the oral drug that is similar to Brexanolone. Note that you have the addition of a ring, so it's not just an oral version of Brexanolone. It is altered, but it is a neuroactive steroid, and it is also now an FDA-approved drug for the treatment of postpartum depression. It is given as a once-a-day dosing, and you see here the plasma concentrations over time.

There were two papers published. Kristina Deligiannidis at Northwell in Long Island has served as the first author, and I had the opportunity to collaborate, our team as well, with many others on these clinical trials. They're very similar. Both of them looked at phase 3 double-blind randomized placebo-controlled trials of Zuranolone. In the first study, it was a 30-milligram dose. In the second study, it was a 50-milligram dose. Two weeks of a daily pill, a once-a-day pill of Zuranolone in postpartum depression.

This was also studied in major depressive disorder outside of the perinatal period. And the robust results for Zuranolone in postpartum depression led to FDA approval for Zuranolone, which was very exciting for postpartum depression, and it continues to be prescribed for postpartum depression. In these studies, it was also women who had significant postpartum depressive symptoms, HAMD, of greater or equal to 26, randomized in a double-blind fashion to receive placebo or Zuranolone at 30 or 50, depending on whether it was the ROBIN or SKYLARK study, followed out to the end. The primary endpoint was two weeks after a two-week period of treatment, and then they were all followed through day 45, and so very similar criteria for the Brexanolone studies but here followed to day 45.

You see rapid onset of action again, but now at day 3. So, Brexanolone, you start seeing onset of action at 12 hours into the infusion. Zuranolone, as an oral drug, you see onset of action at day 3 in the clinical trials, and then you see the difference at the primary endpoint, day 15, and followed out through day 45 of the treatment period.

This shows the difference between response versus remission for the active drug in orange versus the placebo in gray. And you see marked differences over time. The same side effects -- both the ROBIN and SKYLARK studies -- you see sedation being the primary side effect: somnolence, headache, dizziness. Much less intense than what you see with the IV drug, but when it was approved, it was approved with a black box warning that when you take the oral drug, you should be monitoring for sedation.

In the SKYLARK study, which was replicated the study design of the ROBIN study, this time with 50 milligrams again following through day 45, same endpoints, and the same graphs, almost identical, that you saw in the first study. So, these two pivotal phase 3 trials led to the FDA approval of this.

Interestingly, you did not see the same result in the major depressive disorder studies. There was conflicting data, and the primary clinical trial did not have a positive signal in major depressive disorder broadly. That included men and women of all ages. That was the Mountain trial. And so, what happens in major depressive disorder with Zuranolone is interesting. It's also interesting from a women's health perspective, and just the way pharma works and the stock market that Zuranolone was approved as the first oral drug for postpartum depression -- FDA-approved drug -- which was great to see as a new treatment option, and the stocks tanked for Sage Therapeutics because it was not approved for major depression broadly. So, just interesting on the complexity of how all these things fit together.

What's next? We just showed data last week at the International Marce Society on pilot data of Brexanolone in postpartum psychosis, where we have really interesting data that was just presented showing a signal in postpartum psychosis. There's a number of studies that are investigating the underlying mechanism of action of both Brexanolone and Zuranolone. We know they're positive allosteric modulators of GABA. But what does that mean? What is really going on? How do we dive in further to understand who is most likely to respond to this?

I think it's important to note that in the Brexanolone clinical trials, about 70% of people responded to treatment. In the Zuranolone, the oral drug, that dropped down to 60% of people responded -- it's not everyone. So, what is it about the people that are going to respond versus those that don't? And as we think about precision medicine, how do we tailor things so we're giving the right treatment to the right patient at the right time for the best outcomes? The same way we think about it for breast cancer or any other medical illness.

Our group here has been looking at Brexanolone therapeutics in postpartum depression and looking at systemic inflammatory pathways. And I want to acknowledge Dr. Leslie Morrow, the senior author, is a very, very seasoned basic scientist who's been interested in allopregnanolone and neurosteroids throughout her career. And we partnered with patients coming into our clinical Brexanolone program, being admitted to our perinatal psychiatry unit with Dr. Patterson, and then following them over time.

And what we noticed in this investigation was Brexanolone involved inhibition of inflammatory mediator production and inhibition of inflammatory responses to TLR4 and TLR7 activators. And this suggests that inflammation may play a powerful role in postpartum depression, and inhibition of inflammatory pathways may contribute to the therapeutic efficacy of Brexanolone. So, this is an interesting paper. And certainly, as we try and figure out why does it work, that inflammation may indeed be one of the pathways, which, as I presented at the beginning, is certainly one of the theories, at least in some people. And I just want to show the data here. This is Dr. Morrow and Dr. Patterson, and you see that Brexanolone futures altered the in vitro blood cell responses to inflammatory agonists.

So, to conclude, we do know that the pandemic had a terrible impact on mental health, including for mothers and other parents, and has forced innovation and transformation. And it's an exciting time in our field as we think about all the different ways, we can make things better for the patients we serve.

There's a great need for rapidly acting antidepressant therapies. Interestingly enough, in the same two-week period that Brexanolone was approved in March of 2019, so was intranasal ketamine, Spravato, and both those drugs for very different things are meant at being rapidly acting therapies for depression. If you're talking to someone with postpartum depression, or any kind of depression, but certainly postpartum depression, and you have a new baby, and people want to get better faster -- something that's going to work quickly becomes very, very appealing.

The rapid antidepressant effects of Brexanolone and Zuranolone, I think, support the development of neuroactive steroids that are positive allosteric modulators of GABA. And looking at what is the role of this type of drug in major depressive disorder or other types of psychiatric disorders? And how do we develop fast-acting antidepressants to move the field forward? So Brexanolone, I think I will end by saying, is an example of using an underlying hypothesis of pathophysiology to develop novel treatment.

And the aspirational hope is that we will be able to use precision medicine and precision psychiatry to ultimately improve outcomes for our patients, so we have better-tailored treatments -- the right drug or treatment at the right time for the right patient -- because there certainly is a great need to do better for the patients we care for, which impacts the next generation.

So, I'll stop there. Just want to thank all collaborators and the patients who generously participate in this work. Their altruism is inspiring, and to thank everyone at our team at the UNC Center for Women's Mood Disorders.

So, I will stop there.

MELISSA SIMON: Thank you so much, Dr. Meltzer-Brody, and thank you again, Dr. Ota Wang. Those were amazing talks. There are a ton of questions and maybe a few minutes for questions. So, I'm just going to try to get a few of the highlights. Just because we just heard your talk, Dr. Meltzer-Brody, any quick comments about safety in breastfeeding of Brexanolone.

SAMANTHA MELTZER-BRODY: The studies to date have not showed any adverse consequence to use during breastfeeding, and I think with Brexanolone, because you have, you know, the fetus is exposed to third-trimester levels of allopregnanolone that are very high, and Brexanolone is a proprietary formulation of allo given at third-trimester levels. It really becomes an individual decision with the patient and their doctor. And so, we see everything from people that say, "I'm going to pump and dump during that time," because it's a pretty brief time, "I want to have no exposure”, to people that are not particularly worried. There is not an absolute contraindication for either. It really becomes a thoughtful discussion with the individual patient and their doctor on the comfort level and how to proceed.

MELISSA SIMON: Got it. Thank you. And that placebo appears to have a profound effect still. What do you think this is?

SAMANTHA MELTZER-BRODY: Well, I think in the phase 2 studies, you had a very different trajectory where placebo response was much less, and there was a lot of enthusiasm about that. And I think placebo response in depression trials has been one of the banes of the existence of depression clinical trials because people are getting --

you can argue any treatment study, you're getting psychotherapeutic effect of coming in and being cared for. That said, you still see a clinically and significantly different effect from active drug versus placebo.

And I can say that we've had our perinatal psychiatry unit since 2011, and people do not get better, even remotely, as fast as you see with the treatment of this drug. So, it's not just about you're admitted to a unit and therefore you got better -- not even remotely close.

So, I think that placebo response is always a conundrum in all depression clinical trials. People have, you know, really tied themselves up in knots trying to figure out ways around that. It remains an issue, an important issue. And what's remarkable is, despite that, you still saw clinically and statistically significant results.

MELISSA SIMON: And do you think possibly you would continue to see more, better results over a longer period of time because you only have, like, 45 or 90-day outcomes, which are relatively short. So, do you think -- are you intending, or do you think there's going to be studies intending to look at beyond 90-day outcomes?

SAMANTHA MELTZER-BRODY: Yeah, I think that certainly with the oral drug Zuranolone, which is going to be infinitely much easier to take -- most people are going to prefer to take an oral drug once daily as an outpatient -- that there is interest in absolutely knowing what happens after the 45 days of treatment. That's a really, really important question. And I see us at the very beginning of this journey. These are new drugs. There are many, many unanswered questions, and I think that this is the beginning of the journey. But we need to know that as well as many other things.

MELISSA SIMON: So, for both of you -- Dr. Ota Wang, I really want to get equity into this conversation because it's really important. What are your recommendations for making mental health interventions, like standard cognitive behavioral therapy, perhaps others, less lengthy and more adaptive to cultural variations among our different, or very diverse populations?

VIVIAN OTA WANG: Okay, I'm gonna try to be brief with that very important question that really needs a lot more time. I think, you know, practically speaking, it’s really putting the voice and the lived experiences of all people into interventions, and I think that one way to do that is to truly do a comprehensive community engagement that actually goes to all the different sectors of the community to see how they are actually understanding their health care. What are ways that they actually find effective, and that we should be adapting to that instead of them adapting to us? And so, for maybe, you know, individual interventions may work better. There are some that are considered, some segments that have been more collectivistic or family oriented. So, we need to be able to have a menu of ways of doing it, but really being responsive to the lived experience of people in those communities. It sounds easy. It's a heavy lift, but I think it's worth the investment.

MELISSA SIMON: I totally agree. Thank you. I appreciate your answer. And to tag on to that -- so you know Brexanolone, Dr. Meltzer-Brody, is expensive. So how do we mitigate some of these potential disparities in access to this treatment because of that cost?

SAMANTHA MELTZER-BRODY: Well, it is a serious issue, and I can prescribe one of the SSRIs for postpartum depression for patients that you believe need an antidepressant, and that can be obtained for $5 at the Walmart. And so, if you prescribe a drug that is too expensive, and the patient cannot get the drug and cannot afford the drug, then it’s useless to that individual. You know, I have had the honor to work at a large public institution. That’s a safety net hospital for the state.

And so, we serve an extraordinarily diverse group of patients, and we work really hard to make sure patients that need treatments are able to access the treatments.  And I think that certainly with Zuranolone there's been great effort gone into, so far, to have people that want to get it be able to access it, but it's a huge issue.  Cost of new drugs end up being very expensive, as pharma companies price them to recoup research and development costs, and if your patient is not able to obtain the drug, then it doesn't matter whether it works or not.  And that's something we think about a lot and how we think about mental health equity, and that we're treating all people with a drug that will be what's best for them has to be top‑of‑mind, and so it's a really critical issue, not just in our field but in all fields.

MELISSA SIMON:  Thank you. I appreciate you both.  Thank you so much for taking your time to be with us today.  Amazing talks and very enlightening topics that will spawn our next panel's discussion. So, thank you so much!

I am going to transition us to Session One’s roundtable, Clinical Perspectives on Pregnancy‑Related Mental Health Research.  I'm just going to very briefly introduce the four speakers for this roundtable discussion. You can get more details in the agenda and their speaker bios on the link provided in the chat.

Dr. Catherine Monk, she is the Diana Vagelos Professor of Women's Mental Health in the Department of Obstetrics & Gynecology and Professor of Medical Psychology in the Department of Psychiatry at Columbia University.  Followed by Dr. Ai Kubo and Dr. Lyndsay Ammon Avalos; they are research scientists and epidemiologists at Kaiser Permanente Northern California Division of Research. Followed by Dr. Sheehan Fisher, Associate Professor, the Department of Psychiatry and Behavioral Sciences ‑‑ right in my own university, Northwestern.  And then finally, Dr. Nicole Christian Brathwaite, CEO and founder of Well Mind Psychiatry and Consulting.

So, without further ado, I'm gonna start you off, Dr. Monk.  Thank you so much for being here. 

CATHERINE MONK:  Good morning ‑‑ or good afternoon, I guess I should say, and I'm assuming everyone can see.  I also am really pleased to be here.  Thank you for the invitation.

So, I'm gonna be talking about 2Gen perspective on maternal mental health, prevention and intervention.  And here are my disclosures; I'll leave them up there for a second.

All right.  I'm going to be talking very briefly about women's mental health, and that has an asterisk by it because similar to Dr. Ota Wang's talk, I want to be very inclusive in my language and we'll also speak about pregnant individuals, et cetera.  The complexities of gender and biology are absolutely on my mind.  I'm gonna go into something called prenatal programming research, which is really a dyadic focus.  When the pregnant person has a mental health condition, what about the next generation?  And then what are the implications of this dyadic focus in terms of what kind of interventions we want to do and thinking about the health of that future child. And very briefly, because I'm not gonna go through the specifics of the demographics of participants in our studies, I want to say broadly that people range on socioeconomic status, on race and ethnicity, though we are very pleased to have a predominance of Latinx patients in our studies.

So, we've already heard this; I really don't need to go through it.  Women versus men, twice the rate of the two ‑‑ for sure, the two most common mental health conditions, depression and anxiety disorders.  And really to stand back from this, 50% of the U.S. adult population will develop at least one mental health disorder in their lifetime.  We really need to keep in perspective how common this is and how much of a better job we need to be doing in terms of getting people the care they need.

So, what contributes to the higher rates of mental health conditions in women?  Now, Dr. Meltzer‑Brody just gave you such a fabulous overview of understanding some of what's under the skin, the pathophysiology, and I'm gonna pull back and look at some of the psychosocial stressors from that allostatic load, that weathering model, what you experience in your life, in your interactions, in your context, how that can affect your biology, as Dr. Meltzer‑Brody was describing.

So, to start off, this is one of my favorite article titles of all time ‑‑ "Unequal Depression for Equal Work: How the Wage Gap Explains Gender Disparities in Mood Disorders."  So right there, a psychosocial stressor tipping the conditions towards women.  There are other stressors and traumas that women face over their lifetimes ‑‑ disproportionate burden in the care economy, greater emotional stress, balancing paid and unpaid labor, more workforce discrimination, higher rates of childhood abuse and neglect, and higher rates of sexual intimate partner violence ‑‑ and these experiences, these contexts are overlaid on top of the significant biological transitions of puberty and pregnancy and menopause.

We've already heard this; one in seven pregnant/postpartum women will experience ‑‑ I'm gonna be using the term PMADs, perinatal mood and anxiety disorders, as a summary term for these conditions in pregnancy and postpartum, and again to highlight what you've already heard, but these mental health conditions during pregnancy do account significantly for our horrible situation right now of maternal mortality. In this report from New York State, mental health conditions are the third leading factor contributing to these deaths, and they're 100 percent avoidable and it's really about access to mental health care that's affordable, and I'm gonna touch on that later.

I want to really underscore this issue of trauma in women's lives and reference this available‑on‑the‑web report from SAMHSA, really emphasizing the different levels of trauma experiences in people's lives.  So, we're used to thinking about adverse childhood experiences, abuse and neglect, but we can have family trauma, group trauma, community trauma, cultural, racial, historical trauma, and mass trauma, and these different kinds of traumas can be affecting one individual; multiple layers, if you will, of trauma and really needing to keep that in mind.

I also want to reference what we already heard about ‑‑ social determinants of health, how much access to resources and the unfair distribution of that can affect health.  So, I'm using the same slide; I think we already saw before an abbreviated version, but just to emphasize.  56 percent, over half of those living in poverty, experiencing poverty, experience postpartum depression, and then this racialized difference in terms of rates of depression for Black women; again, due to that cumulative effect of weathering stressors on their lives, systemic racism being one of them, contributing to these unequal outcomes in terms of rates of depression.

So, to shift, we're not going to forget about the baby while we take care of the mother.  So, here's what I want to bring in, this dyadic focus.  We can really think about PMADs with the life course and multigenerational perspective.  So, what people experience from childhood and possibly even earlier affects their adult functioning, but as I'm gonna want to demonstrate to you, it also can affect the next generation even before birth.  So, this concept of a person's experiences during pregnancy affecting the next generation before birth is called the developmental origins of health and disease.  It's also known as prenatal programming.  It can also be described as how the first nine months shape the rest of your life.  And here's another great phrase to introduce you to this concept if it's new to you ‑‑ it's one of my favorite phrases ‑‑ "The womb is an influential first home."  This is from David Barker, and Barker is really in many ways the father of this DOHaD field.  And here, what I want to quickly read with you is his conceptual model of how is it that pregnancy experiences are exposures that affect the next generation.

So, in his words, recent findings suggest that human fetuses have to adapt to a limited supply of nutrients, and in doing so, they permanently change their physiology and metabolism. These program changes may be the origins of a number of diseases later in life, such as coronary heart disease and related disorders, stroke, diabetes, and hypertension.  So, what's been added to this model is an evolutionary emphasis recently.  So these maternal experiences are exposures that forecast the postnatal environment to the fetus and the fetus responds with adaptations to improve their fitness in the later stage of life, in the postnatal life, but then the health outcomes may result, in part, from the match between the prenatal and the postnatal environments; and I'm gonna give you an example of that as we go along.  So, you can see that Barker was focused on a nutrition dyad and how that could affect the baby before birth.

Many of us have wondered about the maternal experience of mental health ‑‑ stress, depression, anxiety ‑‑ and how that might affect, before birth, neurodevelopment and the mental health outcomes of those people as they get older.  So, here's a seminal paper in this area, "The Persisting Effect of Maternal Mood in Pregnancy on Child Psychopathology," child mental health problems.  And what you're seeing here on the bottom axis is the age of the children, from 4 to 13 years old, and the Y axis is the percent of people having mental health conditions like ADHD and anxiety, and this is a prospective study looking at people in pregnancy and then following the children.  And what you can see is that for those who endorsed high levels of anxiety in pregnancy, their children had twice the rates of these mental health disorders all the way up to age 13.

Now, this report was seminal and important in our field.  It maybe had some bias in it, because the mother reported on the child outcomes. We've recently done a study with Vanessa Babineau in my lab showing that we have similar outcomes when we do objective tests with the NIH toolbox testing the children, and what we found is maternal prenatal depression was associated with lower levels of inhibitory control ‑‑ so being able not to react ‑‑ and also having sustained attention, particularly in males.  So, you can see how our findings are very much like the prior report I was just describing, really bolstering the evidence for this effect, this prenatal effect.

One of the other challenges to this work is that, is there really an impact to maternal prenatal distress on child outcomes or is prenatal distress merely a marker for the postnatal environment and it's really the postnatal environment that is affecting how those children are developing?  So, we've been doing work, as have many other labs, for a lot of years and we've been looking at prenatal programming effects prior to postnatal influence.  So, we ask the fetus questions.  We assess the fetus in utero in the third trimester, looking at their autonomic nervous system, their heart rate reactivity, heart rate and movement, how much those go together and tell us about central nervous system development, and then we do imaging on newborn babies and we do this ‑‑ as you can see, the pregnant woman in our lab, we're monitoring her blood pressure, respiration and heart rate, and looking at the fetus.

So, what we see in our reports ‑‑ and here I'm gonna use the term "allostatic load" again.  We really asked that question about the kind of manifestation of stress in people's lives, when it's in the body or in the mind, and what you see here is we have 27 different variables.  You can't see them all, but on the top, we're listing some of them with that graph there.  This is in healthy pregnant women with healthy fetuses, and when we asked all these questions and did an analysis, they parsed into three different groups.  We saw in the yellow the physically stressed group ‑‑ higher blood pressure, worse diet ‑‑ then we saw in the red that they had higher depression and anxiety, and the purple were our healthy group.  Well, how they were doing in their stress levels in pregnancy affected the next generation.

So, first, you see twice the rates of preterm birth in the physically stressed group compared to the healthy group, and not only is preterm birth the leading neonatal risk factor for death, but it's also associated with neurodevelopmental outcomes, like ADHD and other problems.  What you're seeing on the right is that coupling of heart rate and movement as a fetus, and you can see the fetuses are doing relatively less well at that.  So, at this time point, the central nervous system development in those physically stressed fetuses of physically stressed mothers is at a decrement compared to the healthy women.  And then looking at who these groups are with the psychologically stressed and more of those social determinants of health ‑‑ less education, more public assistance, lower household income ‑‑ and then the groups, as you can see, differed by the trauma in their background.  So, their childhoods as part of their stress groups are affecting the next generation.

We've done some other work; I'm gonna go through it kind of quickly here.  The Y axis on that top bar ‑‑ let me just focus on that ‑‑ is a change in fetal heart rate when there's stimuli in their environment from their mother reacting to a cognitive challenge in our lab, and the fetuses of depressed and anxious women have a reactivity and the fetuses of those low‑anxious mothers ‑‑ I always say they're imported from California to New York ‑‑ they didn't have a heart rate change.  The fetuses are getting the same stimuli in their environment, because all of the women are responding to the stressor in the lab, but the fetuses are differentiating themselves, showing us they're more reactive if their mother's depressed or anxious.  Those fetuses go on to be more reactive in their temperament at four months old, and we see similar results of depression and basically cortisol being associated with fetal heart rate variability.  There's less heart rate variability in those fetuses.

We've looked at some brain imaging to see less connectivity in the newborn between the prefrontal cortex and the amygdala in fetuses whose mothers had untreated depression.  So that's a more reactive brain; the prefrontal cortex is not as wired to pat down that reactive amygdala.  And a recent report out of Wash U showed that when newborns hear an oddball sound while they're sleeping, those whose mothers are more anxious have more neuronal activation than those whose mothers are not anxious. This is how they were in pregnancy, and, importantly, the neuronal places of activation are in areas that are linked to anxiety disorders in adults, like the medial prefrontal cortex, central lateral prefrontal cortex, et cetera.

So, from a perspective of ‑‑ and I'm just checking my time here ‑‑ of prenatal programming, showing you proof of concept, we're seeing prenatal programming before postnatal influences, preterm birth, evolutionary perspectives, spent less time in a non‑optimal environment, we saw that distress is associated with greater reactivity to the environment.  From an evolutionary perspective, the maternal distress is forecasting an adverse dangerous environment, and the baby is developing to be very reactive in brain and fetal heart rate reactivity; it's prepared for a challenging environment. But that's maybe a mismatch with the environment they come into in the 21st century.  They're supposed to have a lot of control.  So, you can see the manifestations of early symptoms of ADHD and anxiety.

There's been a lot of looking at, again, this pathophysiology of mechanisms.  I'm not actually gonna go through this in much detail, other than just to say we and others have looked at methylation, so the regulation of genes in the placenta that protects the fetus from too much stress hormone, cortisol, and we see differences based on how stressed the mothers are.

So, what are the implications for this kind of work I'm describing?  First of all, we have to be exceptionally careful not to blame the mothers, particularly because factors in people's lives vary unfairly and those are the stressors that can be precipitant to these depressions or anxiety or high stress, and I want the take‑home message, please, to be maternal mental health matters for two generations.  Parenting begins before birth, and for providers, as I am myself, we need to be prepared to answer questions about prenatal stress effects, but I don't think it's useful to bring up these kinds of studies, because the effect sizes are relatively small.  There's lots of room and time for intervention to change any risk factor in that developing child, but I think that prenatal programming research can justify and inform strategies for promoting wellness during pregnancy, and I want to turn to that briefly.

So, the biggest impediment to recovery from PMADs is access to treatment, as I highlighted earlier, and we've already heard.  Very briefly, we have an integrated mental health service in our obstetrics and gynecology department.  I am a clinical psychologist, I'm a direct hire from our ObGyn department.  We're a team of diverse ‑‑ in terms of discipline and other ways ‑‑ diverse providers, and I just want to point out that we are getting people to an evaluation within a week or sooner, and in terms of people actually coming to that first mental health visit, that utilization, we have people coming in at 80 percent of uptake compared to a lot of the other systems.  So, we think our integration and really being there is essential to access to care, and we do take insurance.

We know that there's approaches out there to prevent postpartum depression, and it's really important ‑‑ and Dr. Meltzer‑Brody mentioned this ‑‑ Brexanolone is really developed for those with really significant depressions.  Most depressions we see in the perinatal period are mild to moderate and we can prevent them.  There's the Reach Out and Stay Strong ROSE program, there's the mothers and Babies program and they have evidence backing them.  Elizabeth Werner and I ‑‑ Dr. Werner and I have prepped practical resources for effective postpartum parenting.

You see that word dyadic again. We are preventing postpartum depression working with the mother and the baby in her mind. So, we're working with her in pregnancy.  It's a very brief treatment protocol, five sessions. Again, starting in pregnancy for those who are at risk of postpartum depression.  Mindfulness, psycho‑education, behavioral techniques, and the behavioral techniques are for parenting newborns that are taught before the baby is born.  We can strike while the iron is cold.  We've shown some early efficacy data in the context of poverty as a stressor, having some moderate depressive symptoms, and then an RCT that's currently in submission, depression scores on the two graphs there, and on the far right is a sleep score compared to enhanced treatment as usual.  So, these are preppers lowering these symptoms compared to this enhanced treatment as usual across the board and the different time points.  We can charge now for prep, the insurance.  Most people reach criteria for adjustment disorder in these combined evidence‑based treatments.

Really quickly I want to go back to what separated our allostatic load stress groups most with social supports. We can really think about the role of social support contexts, relationships, communication, and leverage that and bring it into perinatal care.  At University Y, we offer Birth of a Parent/Birth of a Child Zoom support groups. We have weekly groups where we are leading these drop‑in groups on Zoom with community experts to engage patients and share experiences.  I think we can share reliable information that's out there on social media and we can bring that more into the ObGyn ‑‑ I should say the OB space. Kimberly Seals Allers has a wonderful podcast about the joy of being a Black woman and giving birth, which is a wonderful alternative to some of the other statistics.

I want to thank NIH for incredible funding to do our work and thank you all. 

MELISSA SIMON:  Thank you, Dr. Monk.

Drs. Kubo and Avalos will present next. 

LYNDSAY AMMON AVALOS:  Hi. My name is Lyndsay Avalos. Dr. Kubo and I are very excited to be here today to share the work that we've been doing to address disparities in perinatal mental health.  We were funded by NIMH to conduct a randomized control trial for which we call the Healthy Mama and Baby study, or HMB for short, this study was to test the efficacy of an mHealth mindfulness intervention for Black and Latino pregnant individuals at increased risk of postpartum depression.  This study is ongoing and we're not going to share any results, but we will share information about the aims, study design and intervention, as well as the current status and next steps.

So, fist to talk a little bit about the importance of prevention of perinatal depression.  In 2019, based on a systematic review Dr. Monk just showed, the U.S. Preventive Services Task Force issued new recommendations that all women at increased risk of perinatal depression be referred to counseling services. Those at risk of perinatal depression can include a history of depression, high symptom severity, or a history of adverse life events.  In response to this recommendation, there were several editorials included in journals across the JAMA network all highlighting that prevention of perinatal depression is really the key to improving the health of mothers and children. In our team's invited editorial in JAMA Pediatrics, we noted that successful referral of all women at increased risk of perinatal depression would put enormous pressure on existing mental health resources that are already suffering from a shortage of providers. Thus, we highlighted the urgent need for evidence‑based research on other preventive interventions that may not involve intense healthcare system resources, including remotely delivered care such as mobile health or mHealth interventions.

Disparities in maternal mental treatment initiation have been documented, with non‑white populations being less likely to initiate treatment.  In general, perinatal individuals with mental health concerns often prefer non‑pharmaceutical treatments due to worries about the potential side effects of psychotropic medications on their developing fetus, as well as feelings of guilt associated with taking medication.  In fact, qualitative and quantitative research has documented non‑white populations specifically prefer non‑pharmaceutical treatment options.  We know that access to preferred treatment choice improves treatment initiation, adherence, and outcomes.  Thus, this really highlights the need for evidence‑based research into alternative based treatment options, among these mindfulness‑based interventions offer a promising approach for supporting maternal mental health, and among these, mindfulness‑based interventions offer a promising approach for supporting perinatal mental health.

Mindfulness is defined as the awareness that arises from paying attention on purpose in the present moment and nonjudgmentally.  Mindfulness‑based interventions are evidence‑based interventions for reducing symptoms of depression and preventing relapse in many populations without reliance on trained mental health professionals.  Substantial evidence shows that psychological treatments can be just as effective, if not more so than some medications in addressing mental health issues during the perinatal period.  Just over the past few years there have been a few meta-analysis and reviews demonstrating that mindfulness‑based interventions are helpful in improving depression and anxiety during the perinatal period.

However, most previous studies on mindfulness‑based interventions have relied on traditional in‑person delivery methods.  These approaches pose significant barriers for pregnant and postpartum individuals. Financial circumstances, inflexible work schedules and lack of childcare have all been identified as barriers to perinatal depression treatment, especially among women of color. Qualitative research has documented that Latina patients report declining treatment due to family expectations, that they're responsible for parenting duties and that there's no time for treatment.  Additional barriers include transportation and social support, making it harder to access mental health treatment.  There is an urgent need for effective remotely delivered intervention to enhance convenience, feasibility and affordability, all key factors in developing scalable mhealth solutions.  A self‑paced mHealth mindfulness‑based intervention with smaller dosage shows great potential as a scalable and effective approach, especially given the widespread use of smartphones.   Smartphone‑based behavioral interventions delivered to individuals at a low cost have the potential to increase both adherence and effectiveness, making mental health support more accessible and facilitating widespread efficient implementation.

To address these points, Dr. Kubo and I received funding from NIMH to conduct the HMB study.  Now we will talk about the study setting which is at Kaiser Permanente in Northern California.  First of all, the study is taking place at Kaiser Permanente, and I'll give a little bit of background about Kaiser Permanente.  Kaiser Permanente is the largest integrated healthcare delivery system with over 12.5 million members across the U.S., and our study specifically is being conducted in Kaiser Permanente Northern California. KPNC provides healthcare to over 4.6 million members and over 66,000 pregnancies annually, with members living in a 35‑county catchment area.  Members are covered by employee sponsored insurance plans, the insurance exchange, and Medicare and Medicaid.  Coverage is provided for approximately 40 percent of Northern California, and membership is similar with regard to sociodemographic and medical characteristics to the population living in the same geographic area.  We would like to highlight the strengths of conducting perinatal mental health research in KPNC. KPNC has impleneted an obstetric‑based universal perinatal depression screening program which screens over 66,000 pregnant and postpartum individuals annually. They use the patient health questionnaire at three time points across the perinatal period ‑‑ at entry into prenatal care, at 24 to 28 weeks gestation, and at the postpartum visit.

This brings us to the aims of the HMB study.  The first overall aim of the study was to test the efficacy of a mHealth mindfulness intervention among Black and Latina individuals at increased risk of postpartum depression for reducing postpartum depressive symptoms and, secondarily, anxiety and stress symptoms as well as sleep quality.  Our second aim is to test whether the relationship is mediated by aspects of mindfulness including attention monitoring and acceptance. We will also explore whether the associations identified in aim one are moderated or whether they differ by several factors including structural racism and discrimination,  race ethnicity and baseline anxiety symptoms. Finally in Aim 3 we propose to evaluate barriers to and facilitators of implementation of a mhealth  EBI intervention within a KPNC obstetric clinics.

So now Dr. Kubo will share more about our study.

Okay.  So, I'm going to be describing the study design, recruitment process, and our next steps.  Here's an overview of our randomized clinical trial.  So, participants are first contacted, screen consented, then randomly assigned to either the intervention or control groups.  We are collecting self‑reported data at three time points ‑‑ baseline, immediately after the intervention, and  then at postpartum.

For intervention, we are using a mobile app called Expectful.  It's a commercially available mindfulness app that's specifically designed for pregnant people of color, with cultural tailoring for Black and Latina women. One of the key reasons we chose this app is that it offers the Spanish version, which makes it more accessible to a broader range of participants.  The intervention is for six weeks, and we ask participants to use the app daily for 5 to 20 minutes a day.

Because the app is tailored for pregnancy, participants can input a due date at the beginning and the app will automatically provide the meditations that are relevant to their stage of pregnancy. Those in the active control arm receive access to a nature sound app called Nature Space.  This app provides a variety of soothing soundscapes, such as ocean waves, rivers, raindrops, and animal sounds.  Participants are instructed to use the app 5 to 20 minutes a day over a six‑week period.  So, it narrows the mindfulness intervention arm in terms of the time commitment, attention engagement, and ability to use technology.  While both apps are designed to promote calm and relaxation, only the Expectful app includes mindfulness training, which is a key component of the intervention.  So, this design allows us to isolate the effects of mindfulness on those study outcomes.

As target population, we included adult Black or Latina pregnant individuals at risk of developing postpartum depression.  So, we identified those who had prenatal PHQ‑9 score of 10 to 19, and participants also had to be less than 30 weeks gestation, so they can have enough time to complete the intervention before giving birth.  In addition to the remote nature of the intervention, we made the entire study fully remote, enhancing the feasibility and accessibility for both participants and our  research staff.  We leverage the healthcare setting to efficiently identify population participants, streamlining the recruitment.  As Dr. Avalos mentioned earlier, Kaiser Permanente has been screening for depression among pregnant and postpartum individuals over the past decade, which enabled us to access their PHQ‑9 score during pregnancy.  We then employ multiple contact methods to increase recruitment rates.  We're using snail mail, email and phone calls.  Lastly, the entire process from informed consent to screening and surveys is conducted remotely using  Red Cap software, so participants to complete these tasks independently in a secure and user‑friendly environment.

For measures, we are collecting outcomes, mediator or moderators using online surveys at baseline, immediately after intervention, and at postpartum.  Also, we are use EHR electronic health records to obtain clinical data, such as pregnancy complications, medications, other mental health treatment and diagnosis, and baby's health information.  To access intervention adherence, we've partnered with both of the app companies to access back‑end usage data, and this gives us access adherence objectively without relying on self‑reported data. 

Stakeholder engagement:  A key aspect of our study's success is the involvement of diverse stakeholders. We've established strong relationships with Kaiser Permanente's perinatal depression champions, co‑investigator physicians, and the community advisory board.  Their support has been crucial from the groundbreaking phase to the design and implementation of the study, ensuring that it meets the need of the community and is conducted effectively.  Our community advisory board includes a few  mothers, including some who have participated in a pilot stud,y as well as a physician.  Facilitated by a Black and Latina research staff, the board has been instrumental in revising our study name, logo, recruitment materials, and strategies for participant engagement through a series of collaborative meetings.

We wanted to show you some of the study materials.  This is one of the web pages.  We've developed a website in both English and Spanish to provide information on the study to potential participants.  The website also provides information on how to contact the research staff.  We developed a video with assistance of the advisory board, which has been highly impactful in our recruitment process, and I'd like to show you a clip from this video, which features one of the community advisory board members and as well as a physician stakeholder.  And I hope this works and let me know if you can't see anything. 

[Video played]

"The excitement that came with the pregnancy was I was having another son, I was excited.  I was thinking to myself, I'm able to give my first son a sibling.  I was excited about being a mom again, but what came along after that was the stress and me feeling as though, what if I make mistakes?  The way that I experienced stress in my pregnancy was the changes, not only in my body but also in my emotions, a sense of me feeling guilty, as though I was going to not so much pay attention to my other son, because the new son would be coming along.  As a Latina woman, you're pretty much raised believing that you can take the whole world by storm.  And so having these feelings of anxiety, having these feelings of sadness, having these feelings that just were yucky feelings definitely hit my self‑esteem and at times made me feel as though I wasn't good enough.

"We know that both Black and Latina mothers sometimes have more stress in their pregnancy.  Oftentimes they are the center of their family, the center of their household, yet not given room to take care of themselves.

"My emotions were everywhere, and I didn't have an idea of exactly where these emotions were coming from. There weren't any triggers.

"In terms of stress and birth outcomes, there are issues for both the mother and for the baby ‑‑ high blood pressure, there can be issues with baby's growth, mood.  So, the study that we're doing is looking at a mobile health app, so something that you can do on your phone that we're hoping that this simple intervention that people can do for 10 or 20 minutes a day can make a difference in having a more positive experience.

"We need to take every opportunity we can to support our patients, and this study is an opportunity for patients to get help with their mood, with their nerves, with their sleep, so that they can feel better, have closer relationships with their babies, and take care of their families and communities.  This is an incredible opportunity for patients to get support for themselves and for us to show the world that there are relatively simple solutions to problems that are difficult for the patient and for their whole family."

>> So, this video highlights how we can integrate lived experiences and community engagement into maternal mental health and health equity research.

Moving on to retention strategies. Enrolling patients can be challenging but retaining them is even more difficult. So, with the help of the advisory board, we developed several retention strategies.  We send regular text messages to remind participants to engage with the app and to complete surveys.  We also offer compensation for completing surveys and send a card and small gift when their babies are born to show our appreciation.

Since our study is ongoing, we still don't have the results yet but we are sharing our current status today.  We began our study over two years ago and we've successfully enrolled over 470 peopel, and we're excited to report to you that among them, 93 percent of them have completed the intervention and postpartum survey.  Given the busy  and burdensome nature of new motherhood, this retention rate is quite remarkable, and we  attribute this success with the collaboration of  our advisory board to have helped us building the effective retention and recruitment strategies.

Here's quick baseline demographics of the current participants.  Generally speaking, you can see we have a pretty diverse sociodemographically sample. As our next step, after the randomized trial portion of the study, we will evaluate the implementation of technology‑based mindfulness intervention within a large healthcare setting.  We are using RE‑AIM framework to examine reach, effectiveness, adoption, implementation, and maintenance.   We look forward to reporting the results hopefully about in a year or so,  when our study is completed.

We'd like to acknowledge our study staff, advisory board members and participants, and especially for the NIMH for funding our study.  Thank you so much.

MELISSA SIMON:  Thank you. On to Dr. Fisher.

SHEEHAN FISHER:  Thank you, thank you for the opportunity to present this study.  So, this will be a dive into ‑‑ we'll call it PPDA study. This is looking at prevention of perinatal depression in birthing people who have a history of adverse childhood experiences.  So, this is a study that is conducted by my co‑PI, Emily Miller, and I.  Just for a moment, putting my disclosures.

Sorry, my slides are off a little bit. So, we understand that 20 percent of birthing people develop depression during the perinatal period, and I've put an asterisk next to 20 percent, because most of our research, we have to acknowledge, has been mainly on cisgendered women.  So, the 20 percent number is coming from that population.  We don't fully understand what is the rate across all birthing people is, but this is the rate that typically we discuss within the perinatal period.  And we also understand that inclusion of anxiety helps to actually understand better perinatal mental illness, really thinking about early detection, anxiety and depression being highly correlated, then including both of those types of assessments gives us a better idea of the perinatal experience.

And we know that perinatal depression has a direct impact and indirect impact on the birthing parent's functioning and their own well‑being, how they're able to engage in their own personal life, within their life, career, within their relationships, and also how they feel the experience of well‑being, their quality of life, but also with their parenting behaviors.  That has an impact on how they engage in parenting and how that can influence the child's health outcomes, including safety behaviors with the child, but it also has an impact on their relationship that ‑‑ so a previous research study I worked on looked at parental relationships to see how this is impacted by having depression during the perinatal period.  So, prevention of depression really helps to support the family health trajectory, really starting with the birthing parent but impacts the child, the partner, the whole family.  So, we really wanted to take a preventative approach to understanding how we support this family at an early stage before depression develops.

And so, who might be at risk for these mental health conditions during pregnancy?  Obviously, to prevent, we need to better predict and one of the key things that we looked at was looking at adverse childhood experiences, that pregnant individuals who report exposure to these experiences during childhood are at higher risk.  And if you're not familiar with the ACEs, these include physical, sexual and emotional abuses, neglect, and also household challenges that occur during childhood.  So, if you look at this, for abuse, it includes physical, emotional and sexual, as I mentioned.  For neglect, it includes physical and emotional, and then for the household challenges, that includes a history of mental illness, which we know that birthing people who have depression are likely to have had family members who also dealt with mental illness or a parent who treated them violently, experiencing divorce during childhood, having an incarcerated relative, and also substance use in their home.  So, exposure to these experiences during childhood has an impact not only on their stress levels, but it also has an impact on how they relate to other people, how they feel safe and how they found coping mechanisms to support and protect themselves, but they also can develop different types of problems.

So, individuals exposed to ACEs are an increase for various mental conditions, including perinatal depression and suicidality.  This is something that we know through various research, really showing that ACEs is correlated to almost any medical health outcome you can look at; so thinking about obesity, diabetes, cancer, heart disease, and of course depression, and there's many more of these types of medical disorders and outcomes that we can look at, that having high ACEs is related to so many different health risks that basically puts the person at a risk way before they even become an adult. So, this is something that also applies to the perinatal period, thinking about the ACEs that is associated with hypertensive disorders in pregnancy, preterm birth, and also depression during the perinatal period.  So, it is actually very important for us to understand and look at ACEs, to see how we help support these birthing people prior to the birth and during the pregnancy period to ensure that they have the best health outcomes and health trajectory.

So, we know that about 90 percent of individuals in the U.S. are exposed to at least four ACEs or more.  That's about 20 percent of the U.S. population that's at high risk of having these experiences during childhood.  So, if we're looking at this figure, 90 percent of us have had four or more and still, though, those who've had one or more is at 57 percent and you can also see the distribution between it being neglect, abuse, or having different household challenges.  And the burden, though, is also disproportionately borne on those who are historically and socioeconomically excluded populations. I want to highlight that around 61 percent of Black and non‑Hispanic children experience high ACE scores and about 51 percent for Latino children, versus 61 percent for Blacks, and then it's about 40 percent for White children and about 23 for Asian children.  So, it shows that there's a disproportionate impact on black or brown individuals who experience these type of childhood experiences that then have a long‑term impact on their various medical outcomes, but even specifically on perinatal depression.

So, we designed the study, Emily and I, looking at how do we prevent depression in birthing people who have these experiences.  And so, I just want to show our team.  We put together quite a great team, looking for those who've had expertise in psychology, including Caron Zlotnick, who actually created the ROSE program, which I'll discuss later.  We have a case manager, Heather Visser, along with our research coordinators, including research nurses who were part of our team, and then we also have statisticians, Kathryn Riddle for psychiatry, and also Inger Burnett‑Zeigler, who focused on the implementation science.  So, all together, this is the team that supports this research project that I'm going to describe.

So, we had three aims.  The first aim was whether to ‑‑ basically evaluating the ROSE program and looking at particular outcomes for those who have a history of high ACE scores and looking at the outcomes for perinatal depression symptom trajectory from enrollment all the way through six months postpartum, as measured by the PHQ‑9.  For our secondary outcomes, looking at actual diagnosable perinatal depression through categorical diagnosis.  And then our aims also look at the mediators, seeing for this ROSE program, where are the mediators that have a direct impact on this depression risk.  So, ROSE mediators improve self‑efficacy, attachment, soul‑soothing and optimizing social support, and reduction in stress and anxiety symptoms.

And then later, we'd want to make sure that this study can be utilized broadly.  So, we want to look at the accessibility, the appropriateness, the feasibility, and the fidelity of the study, so that we can think about the implementation outcomes and seeing how we can ensure that this study can be utilized for all families.  So conceptually this is how we understood what we're trying to accomplish, that during childhood, children experience these adverse childhood experiences.  So that before even getting pregnant, they might have issues with forecast, not knowing how to trust or engage and have effective and appropriate attachments with other people, and also not really having great access and utilization of social support, partially sometimes due to distrust, or even the environment they have, they don't always know how to get the support that they need, along with also unresolved trauma.  So, we fear that this can lead to, during pregnancy, unmitigated perinatal stress and that's burgeoning during that time, putting them more at risk for depression and then leading to perinatal depression. So, our goal during the pregnancy period is to utilize the ROSE program to give them skills and to help them change their behaviors of how they relate to others and utilize those social supports, so that we can help to prevent depression during the perinatal period.

So, for the ROSE intervention, we include ‑‑ the ROSE program includes enhanced social support.  So, it teaches them how to enhance the social support, how to engage in effective communication, and be able to utilize their social support system in an effective way by trying to find ways to help them mitigate their stress and help to communicate their needs, while also to be able to develop healthy relationships with them.  So, we expect that the mediators of this would, therefore, be development of healthy attachment, having a true social support system, having increased self‑efficacy so that they can advocate for themselves and also take care of things on their own or with the support system that they created. That, in turn, will also reduce their stress and anxiety symptoms, and all that together through the mediators of the ROSE program, we hope to be able to prevent depression in the perinatal period.

So we're doing this within the Collaborative Care model that we have within Northwestern, and that includes routine screening for ACEs and depression by their obstetric clinical team, and then of course refer to the Collaborative Care model for evaluation by the manager to see whether they're positive for depression and to do follow‑up to make sure they get early intervention, and of course we also include all the patient information into a registry to follow their symptoms over time, just to make sure that we're able to track them and to be able to support them and also even look at the data later.

So, for this study, at the point where there's a verification of pregnancy, we screen for the ACE score and that allows us to kind of determine whether they will be eligible for the study. And then also the PHQ‑9, a ten or more would mean that they would not be eligible for the study but would be referred to COMPASS to be able to get support to deal with their mood symptoms. But if they're basically not dealing with depression or a clinical level of depression, then they will be evaluated and then referred to the ROSE program, the ROSE care manager, who will do an assessment of their depression levels ‑‑ or depression score to evaluate them for clinical depression, using the mini-interview.  And then from there, once again, if they meet the criteria for depression, then they're referred back to COMPASS, but if not, then they're put into the ROSE program and then randomized within the program.

So, this is something that we utilized is our flow chart for understanding where the pregnant person meets the criteria and kind of what resources they will receive, but from there they are entered into our study.  And for the inclusion criteria, I just want to highlight.  Initially we had four or more, but what we found was that our rates of having four or more did not meet the national population.  So, then we worked with our PO and adjusted the scores to two and above to be included into our study.  And of course, as I mentioned, for the PHQ‑9, having a score less than 10, they need to be adults, English‑speaking, have at least one prenatal visit at our hospital, have a viable non‑anomalous pregnancy, and also be 12 to 24 weeks gestation.

And so, for exclusion criteria, if they have an active major depressive episode, they would not be eligible, along with having a substance use disorder or a severe psychiatric diagnosis that would have them excluded from our study.  And of course, if they're participating in other studies at Northwestern, if they're involved in another study that would compete with our outcomes, they are not included in the study.

And then we don't have to go into great detail about this, but we also took the time to think about prevention for suicide, just to make sure that we had a protocol in place that if the mom ‑‑ or the birthing parent did report any suicidality on the PHQ‑9, they were followed up with a CSSRS, and then from there we will provide resources to them and support as needed.

Then for implementation outcomes, we also were looking at these key areas to make sure we had reached that population, make sure, of course, that the study's effective, that this was actually adopted by the clinical setting and also by our team.  And then also looking at, for implementation, the accessibility, the appropriateness, the cost, the feasibility, and the fidelity of this study.  And then this is, as I mentioned, is being overseen by Dr. Burnett‑Zeigler, who has specialty in this area.

So, as I mentioned, our study is ongoing.  We've been adapting our recruitment protocols too and starting to get really good pickup for inclusion to our study.

So, I'm just gonna present some preliminary data.  Of course this is just general data from both arms, since we have not looked at it separately yet, because we have not finished the intervention.  So, our population is around mid to early 30s for those in our ROSE program, those who are identifying as female so far within our study; and then for looking at the racial ethnic background, you can see that this is the distribution for the different arms of the study.  But we've screened over 1400 individuals.  Of those, only 166 were eligible, and that plays into, as I mentioned, us having surprisingly lower ACE scores for the ratio within our population.  So out of those who are consented and screened, we have 36, and therefore randomized there were 26, and therefore randomized 14 through the ROSE program, and then 12 within treatment as usual.

This is just a general, like I mentioned, of the data for looking at the depression scores.  So, for the PHQ‑9, seeing that it started at a lower rate, and this spikes a little bit during the one‑month postpartum and then comes back down, and similar types of patterns with the GAD‑7 for anxiety disorders. And then looking at the mediators that were put into our study.  Emotional support, seeing that there's a slight increase for three to six months postpartum; similar things for the dyadic adjustment scale with self‑efficacy, it actually went a little bit down, and the six‑month postpartum; and then parenting sense of competence scale, showing an increase along with similar levels for the self‑efficacy around breastfeeding.

So right now, as I mentioned, this is just preliminary data.  We'll of course parse this out later once we're actually finalizing the study, but we at least wanted to give a general idea of how the study's looking and the measures that we're utilizing.  So, this is a brief overview.  I want to thank everyone who's participating in the study, worked on our team, and of course NIMH for funding this study, and the institutions, Northwestern Medicine where I'm located and also Brown University where Emily Miller is also located.

So, thank you, everyone.

MELISSA SIMON :  Thank you very much, Dr. Fisher.

Dr. Nicole Christian‑Brathwaite. Your turn. Thank you.

CHRISTIAN‑BRATHWAITE:  Thank you so much.

So let me share my screen and hope that all goes well.

And can everyone see?  All right, awesome.

Well, thank you so much for having me, and I've been sitting in on the morning.  So, this has been an incredible opportunity, both to listen in as an attendee but also as a presenter.  Again, my name is Dr. Nicole Christian‑Brathwaite.  I am a board‑certified child, adolescent and adult psychiatrist.  My full‑time role, I am the medical director of child and adolescent psychiatry at Monte Nido Walden, which is an eating disorder facility; and that's an entirely different conversation, eating disorders and pregnancy, that I will not get into today.  I am also CEO and founder of Well Minds Psychiatry and Consulting.  Today, I will discuss from both the perspective of a mother, a survivor of postpartum depression and postpartum anxiety, as well as a psychiatrist who treats and supports postpartum and perinatal people.

Before I really get into the nitty‑gritty of my story, I just wanted to make sure that we were all on the same page. I know many of the speakers prior to me have gone over perinatal mood and anxiety disorders, and I'm sure I'm preaching to the choir, but it never hurts to reiterate a little bit.  Just again a reminder that postpartum mental illness goes so far beyond just postpartum depression, and the perinatal mood and anxiety disorders is really a large group of illnesses, and also remembering ‑‑ again, this is something that I learned in my own personal experience ‑‑ that the postpartum period is actually a full year, not just a few weeks. And I think often we forget that as postpartum women and postpartum birthing people, it takes a very long time for our bodies and our minds to recover from the experience of giving birth. It is a miracle, it's amazing, but it is also really hard, and I realized ‑‑ before I had my first son, no one really told me how hard it was.  I heard all the beautiful and wonderful and cute chubby baby, but no one told me how difficult it is on your body to actually deliver a living being and delivering a person.  So, again, if you are a provider or if you're just a friend ‑‑ excuse me, not just a friend ‑‑ if you're a friend or a support or an individual who's pregnant, just remembering what to look for and understanding that the baby blues really should only be a couple of weeks.  So, if your symptoms of depression or anxiety or really intrusive negative thoughts go beyond those two to three weeks or you're beginning to notice an impact on the quality of your life, please don't ignore it, please seek care, and recognizing that these are very common, particularly among people who have preexisting mood or anxiety disorders.  The rate of relapse postpartum, for example, for depression is about 30 percent, and for bipolar disorder it can be upwards of 52 percent, and over 15 percent for anxiety.

And again, I know I'm repeating what's already been said and preaching to the choir, but given the severity of overlooking postpartum psychosis, I again just wanted to make sure that we understand what that looks like and the differences between postpartum anxiety and the postpartum psychosis.

I recently gave a lecture to a group of really brilliant psychiatric trainees and psychology trainees and none of them were familiar with the signs or symptoms of postpartum anxiety or psychosis or, frankly, any perinatal mood or anxiety disorder, and these were really phenomenal trainees who had not been exposed and would not be able to identify perinatal mood or anxiety disorder in their patient if they were presented with it. They didn't know that postpartum depression is the most common complication of childbirth.  They didn't realize the rates of suicide in women, particularly women of color, and they didn't know that postpartum psychosis is considered a psychiatric emergency.

So, again, when we're meeting with family, friends, or patients, recognizing that the postpartum anxiety, although sometimes paralyzing, may not and is not an emergency.  So you're looking for things like the fixed illogical or bizarre beliefs, you're looking for behaviors that are so outside of the norm or the content of their thoughts being really illogical, noticing that some of the thoughts or the presentation is really a part of a much larger delusional system, and feeling ‑‑ or talking to the individual and realizing that they feel almost compelled to act on these thoughts or feelings.

I'm going to play a very brief video, which is a story from the mother of a young woman who experienced postpartum psychosis, and it's a very, very brief video, but I do want to offer a trigger warning that she talks about her daughter taking her own life.  And so, if this is not something you're comfortable with, I do want to offer that trigger warning before I share the video.  So, if you wanted to just take a second to lower your volume or step away, please do so. 

[Video played.]

"I knew something was wrong, but I didn't know what.  Every day she became more distant from me and really never looked at the baby.  And when she did look at the baby, she told me that the baby hated her.  She said, 'Oh, Mommy, I'm such a bad mother.'  She said, 'The baby doesn't deserve to have a mother as bad as I am.' She just seemed to have gone into a whole new world all her own.  It was like a monster had entered her body.  I'm telling you; I have never seen anything like it in my life.  She got a cab, she went downtown, she checked in a hotel, and she went up to the 12th floor and she jumped out of a window, and she left her brand new baby that she never got to enjoy.  She left me and broke my heart, but it also made me extremely angry, and I thought, I've gotta do something.  I can't let this murderer kill my daughter and then not try to go after it.  I can't have something called postpartum psychosis take my wonderful daughter from me. I had no idea how deadly it was, and I've done everything that I can to expose this monster, but I haven't done enough, because women are still in prison and women are still committing suicide under the influence of postpartum psychosis and harming their babies."

DR. CHRISTIAN‑BRATHWAITE:  Going to specifically my experience in addressing Black women ‑‑ Black and Latina women, we're in a crisis.  As we've heard from multiple speakers sharing their data, disparities exist throughout medicine.  There literally is not one field of medicine, not one illness that we can look at that we're not identifying disparities where Black and Latino people ‑‑ or Black and Latina women have poor outcomes.  Again, not because of race, but because of racism and the structural, institutional and individual racism that exists throughout medicine.

And again, I won't take a lot of time going through this because a lot of this has already been reviewed, but while about 20 percent of women overall display a sign of perinatal mood or anxiety disorder, when we start looking at African American women, that number more than doubles.  Nearly half of Black women suffer from a perinatal mood or anxiety disorder, but they are much less likely to be screened or treated appropriately.

There was a study a number of years ago from New Jersey ‑‑ I'm originally from Philly, so my preference is more of that northeast area.  But when they looked at Medicaid claims, they found that white women were nearly twice as likely to receive treatment than Black and Latino women, and yet when screened, Black and Latino women were suffering more often, and by the time they entered into treatment, often their symptoms were more significant and more debilitating.  And in general, just to note, rates of mental illness do not vastly differ between African American populations and white populations, but, again, because of delays in treatment, because of misdiagnosis, because of inappropriate treatment, the severity of symptoms and rates of morbidity and mortality are much worse, because the outcomes ultimately are worse.  And again, as we know, suicide is a significant risk factor of perinatal mood and anxiety disorder, and as a result, African American women are at a greater risk of dying from all causes of perinatal or postpartum complications, but certainly from suicide.

The next point that I want to make, truthfully, was almost surprising but not surprising to me, but when we think about financial security and we think about socioeconomic status, I think we assume that the more money you have, the better off you'll be; that the more money you have, the more doors are open to you, the better healthcare you have access to, but unfortunately for Black women, that's not the case. The more education you have, the more money you have, it doesn't improve your outcomes, it's not protective.  When we look at white women, their outcomes do change with greater education and greater money.  And previous research has actually shown that Black mothers and babies have the worst childbirth and morbidity and mortality outcomes, even with significantly more resources.  I'm sure we've all heard and seen Serina Williams' story.  I don't think you can become much higher‑profile than her, and when she was asked about her experience in the hospital and her complications postpartum, she was quoted saying, "Doctors aren't listening to us. There are a lot of prejudging that definitely goes on and it needs to be addressed."

I'm sure also many of us have heard of the story of Kira Dixon Johnson.  She was ‑‑ the TV personality judge, Glenda Hatchett, this was her daughter‑in‑law.  And the more I read about Kira ‑‑ and if you haven't had a chance to Google her, please do.  Her husband is a very active advocate and has done a lot of work and talks around her life, but he talks about Kira as almost as this superhero.  She spoke four languages, she had her pilot's license, she drove race cars, and she was considered to be in excellent health. Yet, her husband describes after a C‑section her spending over 10 hours bleeding internally before dying in the hospital.

And ultimately, what this tells us and what my experience has been, despite being a physician, despite being a psychiatrist, Black women, Black birthing people are not seen, we are not heard, and often we are not respected.  Our pain is ignored, and again, we know this.  Data shows that there are providers, physicians who still believe that Black people's nerve endings are different, that we feel less pain.  So as a Black woman, when we complain, our complaints are ignored, because there's this thought that we somehow are exaggerating or we're not feeling the pain that we think we're feeling.  Not to say that that's the only reason, and we'll kind of get to some of these reasons that Black women and Black birthing people are dying, but it's certainly one.  Black women's voices are not respected or heard in medical institutions.

And I frankly wish I knew me now when I was pregnant.  So, despite being a psychiatrist, as I said, despite understanding and practicing medicine ‑‑ I live in Boston and per capita we probably have more psychiatrists here than many other states and countries in the world.  I was not screened and I, for months, struggled to access care and ultimately hit rock bottom and began to have thoughts of taking my own life.  And before I go into more detail around my personal story, again, I do want to offer a trigger warning around my story.  It involves loss, it involves miscarriages, it involves severe postpartum depression, and it involves suicidal ideation and thoughts.  So, again, I do want to recognize that this is a difficult topic to discuss, and for some people, they may not be ready to hear this.  And so, I do want to give that trigger warning and give everyone the opportunity to step away if this is not something that you're comfortable hearing.  But it is something that I feel is important for me to share, because I struggled in silence for so long and I felt so alone and so isolated and so judged and I truly beat myself up during and after experiencing postpartum depression.

You know, I sometimes still struggle when I go through and think about my story, but certainly at the time, I struggled opening up about experiencing postpartum depression.  And frankly, I didn't know about it.  Even though I was a psychiatrist and a child psychiatrist, I hadn't really been trained.  I was not exposed to the risks of postpartum depression and what it exactly looked like and how to appropriately treat it.

So, I'll forewarn everyone, I'm going to use this opportunity, because it is about lived experience.  I'm going to use this opportunity to do a family slide show.  So, you will be subjected to many, many pictures of my completely objective opinion of my beautiful boys, who are now eight and ten.  And these are my babies, but if you happen to come across my 10‑year‑old, please do not tell him I publicly, in front of hundreds of people, called him a baby, because he will say I have absolutely ruined his life. And he is not a baby; he's a very mature 10‑year‑old.  So, we'll just keep this between us.  You know, again, I was a psychiatrist.  And this picture on the left, this is my husband.  I was eight months pregnant.  The picture on the right, I had just presented research ‑‑ a poster at a national conference.  At the bottom is my first‑born.  He was 9 pounds, 14 ounces of yummy baby, but it was a very difficult pregnancy and a very difficult delivery.

So just to be honest, I wasn't screened. I wasn't screened by my OB; I wasn't screened by my PCP.  The only person who expressed any concern was my son's pediatrician, an African American pediatrician.  Her name was Dr. Jean Broadmax, who was just absolutely phenomenal.  But I will accept responsibility.  I was reluctant to seek help at various stages of both my fertility challenges and my postpartum depression.  We suffered a miscarriage before my first son and I remember lying in bed for days just weeping, and I truly hid my pain from my husband, from the world.  Now, in hindsight, obviously I recognize I was suffering from depression even at that point, and I didn't tell and none of my providers asked.

In addition to the stigma of mental health in black communities, there's certainly the stigma around infertility. It just wasn't discussed.  I found out much later when I talked to people, when I opened up ‑‑ "Oh, yeah, that happened to me.  Oh, yeah, I went through that too."  Nobody wanted to tell me that we have this beautiful community here and nobody wanted to let me know that I wasn't alone, but I also realize that I wasn't ready to share.  But I truly felt like a failure; I started questioning myself and my womanhood. And after another year of trying and a second miscarriage and fertility treatments, we finally got pregnant, and I think I was a little bit too excited because I gained well over 50 pounds with my first pregnancy.  So I think I was so grateful to have been able to become pregnant, recognizing that not everyone can do that and realizing how much we had to go through, that I felt like I was a terrible person because I wasn't grateful for this beautiful baby that I had with me, but I also didn't realize that I had numerous risk factors for postpartum depression.  I didn't know that because of my traumatic birth where I had third‑degree lacerations and I had more than one third‑degree laceration ‑‑ I didn't realize that an intern needing to do five attempts at placing an epidural during active labor, which I considered to be traumatic, increased my risk factor. I didn't realize that having difficulty breastfeeding because my son had a tongue‑tie was a risk factor.  I didn't realize that excessive sleep deprivation because I had a colicky baby was a risk factor.

So, there were all of these things that I was experiencing, let alone previous depression, that I should've been screened.  And there should be universal screening, but I certainly should have been screened, but, instead, I walked around feeling like a failure, really truly believing that my family would be better off without me.  And everyone just kept telling me how beautiful my baby was and how blessed I was, and I'm like I am, right, but why don't I feel it?  Why am I so sad all the time?  Why can I not stop crying?  And it just finally got to the point where one day I was driving to work ‑‑ because I only got two weeks of maternity leave at the time ‑‑ and I was driving to work and the postpartum depression truly said, "You would be better off dead”, and I thought about driving my car into a median. And at that moment I received a phone call, and I don't even remember who the call was from, but it stopped me from actually attempting to hurt myself, to take my own life.

And I finally reached back out to my son's pediatrician, because she was the only provider who had expressed any concern, and she helped me find a therapist and a psychiatrist.  It still took weeks, if not months to get treatment, but at least I felt like I had support and I had a place to go.  Subsequently with my second child, I was more prepared. I was on medication, and I still ended up with postpartum anxiety, but at that time, at least I had a team, and I had support, and I wasn't going in blindly.

And just quickly, because I realize we are at time.  Again, these are all risk factors that we're aware of and certainly need to teach and communicate about, because, again, there's so many risk factors that exist and our patients, our family members just don't know that as a result of different lived experiences, they're at much higher risk of experiencing a perinatal mood or anxiety disorder.  One thing that I'll just quickly point out is something called weathering, and earlier one of the speakers talked about the allostatic load, the stress of simply living as a Black person, a Black woman or a Black birthing person in the U.S. leads to stress.  And the researcher who coined the term mentioned this quote in one of her papers: "African Americans are expected to do things even though they were set up for failure, and if they succeed at them, it exacts a physical price.  There is a toll to having to prove yourself all the time and interact with the people who disparage you."  So, essentially, "weathering" means that physiologically, on average, Black people are ten years older than their white counterparts. Even though we know the term black doesn't track on the outside, but on the inside our bodies are suffering and aging prematurely.

And again, why the discrepancy? There are many reasons.   

Certainly, one is just a lack of education.  There is brilliant research happening, as we've seen today, and that is not being translated into education ‑‑ not in medical school education, not in education around social work, nurse practitioners, residency.  We are not learning these important facts.  We are not learning that women and birthing people are suffering and dying, and this research needs to be translated into education in order for it then to be translated into daily clinical work.

And that's my very sweet baby when he would have a sad face, and I just thought it was the yummiest thing ever.

So next steps, now what?  Again, there are a number of things we can do.  Certainly, in Massachusetts, our House of Representatives passed a comprehensive maternal health bill that creates a state licensure pathway for midwives and certainly covers postpartum depression screenings, which is a huge step forward.  We need to screen everybody.  Any birthing person that walks into your office ‑‑ no matter what your degree, your background ‑‑ screen them, ask them questions.  Again, incorporating research, listen to Black women.  Listen to us, hear us, screen us, but then ensure that ‑‑ we're using certainly the Edinburgh postnatal depression screening, but going beyond that, listening to make sure there aren't somatic symptoms that you're missing, other cultural symptoms that may not present in a typical way.

Lastly, because of my experience I decided to pursue additional training.  So, I went through the Postpartum Support International and received certification in treating postpartum people, which I feel like both educated me but also increased the number of clinicians and providers available, because so many behavioral health providers are afraid to treat birthing people and we really have to change that, and the best way to do that is through education.

Thank you.

MELISSA SIMON:  Thank you so much for that really powerful personal story and talk.

I'm going to bring all the panelists back up here.  You all gave us a lot of things to learn and food for thought, and wow!

Yeah, I need a moment too.  I personally have experienced six‑plus childhood ACEs growing up, and so, yes, this all speaks to me.  And I have four children.  So, this all is very hard for me as a moderator right now.  So, what we all heard specifically relevant to today's series of roundtables is about the power of research and research that includes personal on‑the‑ground experience to inform how we give better care.  This panel was for clinical care of pregnant and birthing persons with respect to mental health and well‑being, and so I really would like to take a moment and hear from you all about critical research gaps, because you clearly are doing some amazing state‑of‑the‑art research.

Right now, we do have some more funding at NIH and some funding opportunities through the White House initiative and IMPROVE and other initiatives as a start.  It's not enough.  I mean, we have about 51 percent of the United States population is pregnant‑capable at one point in their life, a little bit more or less, and yet not 50 percent of the NIH budget focuses on people who are pregnant‑capable.  Not that I'm saying that all research should focus on pregnancy and postpartum, but the people who have pregnancy capability have different needs and a different life course in terms of their health and well‑being and different types of healthcare at different epochs in our lives.

So, what is critical, one critical research gap that would address specifically pregnancy‑related mental health in clinical settings that you think should be at the top of a funding proposal request, an RFA or a program announcement for NIMH in the next year or so? Go ahead, Dr. Monk.

CATHERINE MONK:  Can I jump in.

Such a pleasure to hear all these talks. I'm gonna say two things, one of which is gonna be very unpopular and not actually what you had in mind.  One of them is, I do think as the IMPROVE initiative is done ‑‑ and I'm proud to be part of one of those centers of excellence ‑‑ is to require community experts and people with lived experience to be part of any grant applications.  That's part of any project and already it should be part of the planning, and then they should be funded comparable to other PI's and staff to be on the project and bring in new ideas.  I really think the rate limiting factor is we have to have financial models, economic models that support access to mental health care.  And we can screen and screen, but if we don't have places to send people that they can afford and access care, it doesn't do anything.  So, I think funding that actually allows us to ask questions about the financial model and what works is huge.

MELISSA SIMON:  Thank you. Wow, everybody's hand's up.

I think Dr. Fisher and then Dr. Lyndsay Ammon Avalos.

SHEEHAN FISHER:  So, one is just, as I mentioned, we need to do more research on birthing people broadly, so that we don't keep reiterating a hetero‑normative view of the family unit. It just means that I think for the newer generation, about 20 percent identify as cisgender minorities.  We're gonna miss a huge part of the population if we don't take that part seriously to make sure we have interventions that's specifically designed to them, but in order to do that, we need to understand their direct experiences.  And I just came back from the Congressional Black Caucus.  They were talking about ‑‑ I was on a panel focused on utilization of the father to support mom's mental health.  So, I think we need to think about the partners, how they can be utilized, and we obviously have a shortage around providers, especially for Black and Latina families.  So, I know Congresswoman Underwood has a program for an omnibus that she's trying to push forward to help that.  And in the meantime, we need to figure out how to re‑train the fathers or the families or something to support the family, because we don't have enough medical providers who are in the Black and Brown environments to support them, and to best address, we need to do something to support the families directly.

MELISSA SIMON:  Thank you.

Dr. Ammon Avalos.

LYNDSAY AMMON AVALOS:  Yeah, I think in addition to the points that have been raised already, one thing that we all kind of raised as well is prevention and really addressing prevention and not necessarily treatment only but identifying scalable interventions that can be used and accessible and acceptable to diverse populations.  As we know, there is a huge shortage of mental health care providers.  So, we really need to identify other evidence‑based interventions that are scalable and that address prevention, I think.

MELISSA SIMON:  Yeah.  So, workforce and research data, actionable data, implementation science, bridging NIH funding opportunities with CDC/HRSA, more on‑the‑ground implementation type grant opportunities from the other federal agencies in partnership.  We're gonna hear more about that next.

Dr. Monk.

CATHERINE MONK:  Can I just jump in for a second?  Thank you.

I agree we need to diversify the workforce, not only in terms of demographics but in terms of different skill sets and work with midwives and doulas absolutely great, but I just want to question the issue of having a mental health care workforce shortage. We do have that certainly in rural areas.  In places like New York City and Boston, we don't actually have a shortage, but we have a shortage of people who take insurance.  So, I have no problem making a referral for someone who can afford three to five hundred dollars a week.  I cannot find people who are taking commercial or government insurance; that's the issue.  I think we have to be really clear about that, because it does come down to the financial incentives and it's such a huge problem.

MELISSA SIMON:  Thank you for highlighting that.  Yeah, many people are charging $300 an hour, $350.  That is not sustainable or not even accessible to most of us.

Do you foresee ways in which technology could enhance mental health care to help reach people who may be in rural areas or who aren't able to pay the 300‑plus dollars an hour?

We've got lots of hands.  Dr. Christian‑Brathwaite.

CHRISTIAN‑BRATHWAITE:  So, I think it goes back to Dr. Monk's point.  I used to work in telehealth.  Pre‑COVID I was in the technology behavioral health boom, and then with COVID we saw all of these start‑ups, but it didn't necessarily improve access.  One, because people in rural communities may not have the internet bandwidth, may not have the understanding.  I can't tell you how many patients, like the entire visit was looking up their nose because the phone was like here, or like they kept breaking up or they didn't have a space big enough in their own home to be able to privately have a conversation.

So, I do think technology can be helpful, but, again, if it's all out of pocket or if the technology advances don't benefit everyone, those concerns still exist.  I still think telehealth is a very effective median.  I used to have a clinic ‑‑ I live in Boston, but I used to have a clinic in very rural Illinois where there was no child psychiatrist for over a hundred miles.  So, I really was the only option for many of those people, and I worked in an organization that accepted all insurance, but that's not the case universally.  And so there really will need to be changes on a local but also legislative level to ensure that providers are paid for the work that they're doing and there's true parity and the reimbursement rates are appropriate for every level of care.

MELISSA SIMON:  Dr. Kubo.

AI KUBO:  I agree with what folks just said.  I do think that ‑‑ I've been doing technology‑based interventions for over a decade, and there seems to be more preference, especially among people who have depressive symptoms, not to do in‑person and be in a private setting.  So having technology, being able to reach more people and perhaps having integration with electronic health record, so that the clinicians can also track adherence, especially in a setting like what we have. We can integrate, say, mobile app or other technology‑based platform to their medical record, which can allow clinicians to monitor their progress and mental health.  So also, technology and just use of electric health record to monitor patient can be useful in coordinating different providers, which is not just mental health providers, it's obstetrician and so on.  So, I do think it's really a key in mental health care.

MELISSA SIMON:  Thank you.

Dr. Fisher.

SHEEHAN FISHER:  Yeah. I will just add I agree, but also, like you mentioned, using apps to make sure we can reach rural areas.  Even now that AI is kind of burgeoning, we can think about ways to use that for treatment or even prediction.  There's a lot that I think can be done.  I just submitted a grant on this, trying to use the ROSE program but adapted in that way to really try to address Black and Latino families, given they don't always have the accessibility; they can't always pay $300 an hour for intervention, but how can they still get support and clinical treatment.  So, I think there's a lot that needs to be done moving in that direction, but of course, once again, we still need to address the workforce too, and also understand who's influencing the development of those things to make sure it's coming from a diverse background as developing that technology.

MELISSA SIMON:  Thank you.

Dr. Christian‑Brathwaite, did you have another comment or is your hand up from previous?  Hand up from previous, no worries.

CHRISTIAN‑BRATHWAITE:  I'll lower it, sorry.

MELISSA SIMON:  So, I assume it's correct to say that if a person is experiencing postpartum depression and they get pregnant again within one year or less than the recommended two years that general ObGyn, obstetrics care providers recommend, I assume that it compounds the depression and could cause postpartum depression more likely to happen in the next pregnancy.  That's correct clinically, if somebody gets pregnant within a year and already had postpartum depression from the current postpartum period.

Dr. Fisher. 

SHEEHAN FISHER:  I will say yes.  I think clinically that's something I do discuss in working with patients, is kind of seeing when they recovered.  And we don't look at it in a bubble, because there are also the social determinants, like their environmental factors, the fact they don't have parental leave, they don't have access to ‑‑ even some of the financial aspects of supporting two kids and things.  I think there's a lot to be aware of the risk factor for them developing depression again. You know, it's not like a rule of thumb, but it's really a conversation with them to see how much they at risk are and what are those factors that need to be addressed prior to getting pregnant again, to make sure they're on the best footing, which usually actually leads to positive outcomes.

MELISSA SIMON:  Thank you.

So then, family planning opportunities and contraception and other things to space pregnancies is really critical, more so than in other pregnancies, but really critical when somebody is experiencing postpartum depression. Therefore, I'm thinking about recent, you know, policy changes in our country around Roe versus Wade being overturned and relative pockets of our country and regions of our country that don't have as much access to contraception or family planning opportunities as other parts of the country. So, I think this is really an important area of research, as well, of what's happening there with respect to pregnant persons and postpartum persons who are experiencing depression but then also don't have access to space their pregnancies with the tools that we have in modern-day clinical care.

Any comments on that? A lot of heads shaking.

Okay, all right.

CATHERINE MONK: I think there's a JAMA report from a couple of years ago, just when the Dobbs decision came out about a year afterwards, showing increased rates of depression in trigger states. So, there's already -- and then there's just no doubt that that's going to be one of these stressors, and it's not going to be equally distributed for many reasons. And it's going to lead to another aspect of, you know, of a risk factor. I just really want to emphasize that yes, a prior depression at any point in the life course is a risk factor for postpartum or pregnancy depression. However, having gotten treatment that was effective can be really protective, especially if the person can reconnect with the provider. I'd like to think, can go back to the tools that worked. Maybe that someday will be on an app. I mean, it can be really strengthening of a sense of resilience to have overcome and to feel like you have the team together as you go into a second or third pregnancy with a concern about depression.

MELISSA SIMON: Thank you, and on that, I am going to give us all a 5-minute break before we transition to the next panel. Thank you all for your time, your stories, and your amazing talks. Thank you.

5-minute break, everybody.

[BREAK]

MELISSA SIMON: Thank you. I appreciate y'all. Okay, we're going into session 2, everybody -- Innovative Models of Maternal Mental Health Care. We have again more phenomenal speakers, just like we've had a whole panel before of phenomenal speakers. I'm going to introduce all four of our speakers, and then they'll just come on sequentially. Okay, again, I am only giving a one-liner for each of their amazing biographies that are super, super extensive. You can refer to those speaker bios online, and also to the agenda through the links provided in the chat.

The first of our panelists for innovative models of maternal mental health care is going to be Dr. Mary Shaw, who is the Chair of the Department of Behavioral Health, Promotion, and Education at Jackson State University, followed by Dr. Wanjiku Njoroge. She is an Associate Professor at the University of Pennsylvania, Perlman School of Medicine, and the Medical Director of the Young Child Clinic at Children's Hospital of Philadelphia, followed by Dr. Kara Zivin, who is the Marcia Valenstein Collegiate Professor of Psychiatry and Professor of Health Management and Policy, and a Research Career Scientist at the Center for Clinical Management at the University of Michigan. And then, last but not least, Dr. Nima Sheth will join us. She is the Associate Administrator for Women's Services, the Chair of the Advisory Committee for Women Services, Senior Medical Advisor for the Substance Abuse and Mental Health Services Administration, or SAMHSA. So, I'm going to start this panel off with Dr. Shaw. You're on.

MARY SHAW: Got it. Okay, so I'm going to shift the conversation a little bit. We are also funded by the NIH IMPROVE, and I want to kind of go back and address several things that were addressed in the first panel. Actually, they set me up very nicely to talk about the rural setting. And I'm going to contextualize this as health culture in place, because the conversations are a little bit different when we start talking about rural Mississippi. I appreciated Dr. Braithwaite's discussion when she said, we've got a lot of psychiatrists. We've got a lot of mental health professionals, and you flip that in Mississippi. We are a little bit more challenged.

So, I want to start off with a quote, the context being, when you're in Mississippi, the rest of America doesn't always seem real. And when you're in the rest of America, Mississippi doesn't seem real. I think that is the context for the work that we find ourselves trying to do here in Mississippi. We were funded as a Center of Excellence at an HBCU to address what we refer to as preventable maternal mortality, decrease severe maternal mortality, and promote maternal health equity in partnership -- key thing, in partnership -- with the Mississippi Delta community. Jackson State, as most of you all know, is actually in Jackson, Mississippi. So, it takes us approximately 2 hours when we're commuting back and forth to the various counties that we're working with.

So, the Mississippi Delta Center of Excellence in Maternal Health is a collaborative. And I'm really pleased to say that it's a collaborative where we have people from different institutions. We have the Health Department working with us. It's Jackson State University, the University of Mississippi Medical Center, and the Harvard T.H. Chan School of Public Health is working with us. And then I think I heard someone mention some of the challenges around reproductive health and access to contraceptive options. And so, one of our partners is Converge Partners in Access to deal with some of the issues in the rural counties. We have framed our partner networks because we have a number of -- this particular project, a big piece of it is community care, so MommyCare Postpartum Community/Partner Networks.

These are the principal investigators that are working with the Jackson State Center: Dr. Tiemeier from Harvard. Dr. Polk has actually transitioned, and we have another person in her place now with the Mississippi State Department of Health, and she is a social worker. Me. And then we have our community partner, the individual who's helping us make the connections across the Delta counties. We have 82 counties in Mississippi. Much of Mississippi is rural, so this conversation is really specific to the rural communities and not the cities in Mississippi.

So, we had four aims for the project, and I highlighted the key pieces: determining the effectiveness of an evidence-based community worker home visiting program. Community workers -- our keyword -- those individuals who are indigenous to these rural counties that I'll talk about, grounded in extensive patient and community participation. Project 2 aims to evaluate the effectiveness of a multi-level patient clinical linkage, and the key pieces for us is how to increase trust and engagement in postpartum healthcare among Black women in the Mississippi Delta.

Aim 3 is focused on our community partners, and we had to have them in order to have meaningful and equal community partnerships because the community partners are key to the success of this research endeavor because of the cultural context that they bring to this project.

And Aim 4 is establishing a training program for early-stage investigators to address the interpersonal and structural factors that many of the individuals who spoke this morning talked about when we start talking about mental health.

The key components of the Center around Project One. And if you notice, it says, evidence-based community worker home visiting program. So, we know that home visiting programs are not new. We know that there are a number of them, some of them focusing across the continuum from pregnancy, through delivery, through postpartum. But our home visiting program is only focusing on the postpartum period. And the reasons for that stem from many of the comments that you all made earlier, where we know that in Mississippi, where we have some of the highest mortality and morbidity rates in the country, that a lot of these situations happen in the postpartum period. So that's where we're focusing. We're looking at the mental health piece as critical to the overall health and well-being of these women when we make these home visits.

Project 2 is more focused on looking at the community connections, the partners, and to what extent women are experiencing health literacy issues, whether that be perceptions that the provider doesn't communicate well, or they're challenged with understanding what these providers want to communicate. And this issue of trust and engagement. We know we have a large number of women after they give birth, and I'll talk about this a little bit in a few minutes about the distance that women in the Delta have to travel to get to the University of Mississippi Medical Center if they're high risk. And our target group are high-risk women who are from five different counties in the Mississippi Delta, which I've already said. It's about 2.5 hours to each of the counties, and I probably should have put a map in here. But we're talking about women who are referred from their local OB/GYN or clinics because they're high risk. They're determined to be that early on in the pregnancy, and so the commute to Jackson, where the University of Mississippi Medical Center is located and can handle the high-risk cases, is about 2, 2.5 hours. So, I want you to keep that in mind. So even for mental health services, if we're talking about referrals, many of these may be referrals into Jackson, but there could be some that are happening in the Mississippi Delta. So, our partnerships with community-based organizations, service providers, those are so critical. And the relationships that exist between the women and these organizations.

And then the training program is specifically intended to increase the number of early career investigators who are interested in working in the Mississippi Delta, in partnering with those organizations so that we can do more translational kinds of things to know what's evidence-based, and to be able to apply it in these Delta counties. And of course, the most important people in this entire venture are our community partners, so facilitating relationships that support equity in postpartum care. And I think I heard someone earlier talk about the importance of NIH and other federal agencies that are interested in postpartum and maternal healthcare to begin considering funding those community organizations that can do this work.

So, here's a little bit about what we call the “Thee JSU” research team. Project One is actually led by the Mississippi State Department of Health. Dr. Polk, who has retired, is still going to be working with us from the Division of Health Services, and the Co-PI for that is Dr. Henning from Harvard. The target population are high-risk, Black postpartum women who meet the eligibility criteria. And actually, we selected 5 counties, 5 counties in rural Mississippi, because those counties are where we have the highest number of pregnancies for teens. And so, we were projecting out, looking at teen births as an indicator of potential high-risk women that could participate in the study. We will recruit from 5 of those counties where we have seen some of our highest rates of birth mortality and morbidities. But now, remember, I have to go back and say, these women when they're referred, they come into Jackson. And that's another set of issues that we'll have. We can talk about that very briefly when we have the panel discussion.

Project 2: Empowering Women for Postpartum Care and Reproductive Health. So that is housed here at Jackson State, and I have a wonderful team working with us, and there are two junior investigators, Dr. Angela Omondi, and Dr. Felicia Caples. Our team is very diverse in terms of coming from different backgrounds, so we don't have -- I think we have two clinical people, and then the rest are coming from other areas, fields related to public health. So, the women who are enrolled in Project One are potential recruits for Project 2. But we will also be recruiting directly from clinics and hospitals in the Mississippi Delta counties, and we're talking about recruiting providers and women from the participating clinics. The only criteria are that they have to be receiving services in the selected counties.

This is kind of our community partner, the young lady that I showed in one of the earlier slides. We had to map what's happening in these counties. Who? Where are the providers? What type of OB/GYN services? What type of mental health services? So, we had a better picture of what was actually going on about in terms of accessibility, availability, affordability, and acceptability to the women that we recruit into this particular project. So, you see that there are five counties. So, it's Bolivar County, Carroll County, Humphreys, Scott, and Washington County, and there may be people on this webinar that are familiar with how these counties are located in proximity to the Mississippi Delta.

We also have some other partners that are critical to the work, and that's the Children's Defense Fund, the Women in Health Children's Imperative, the Diaper Bank of the Delta. We have, when you see ROSE/MOM ME, that is an organization that has worked extensively to increase the number of baby-friendly hospitals in Mississippi, and as well as provide lactation support, the Mississippi Department of Health, and again, the Mississippi Center for Justice. One of the challenges that I'll talk about a little bit later is making sure that women have access to a range of contraceptive choices, and I'll talk a little bit about what Converge is going to be doing with us as one of our partners.

So, we've kind of framed everything around for HER: health, education, and research. MommyCare Postpartum, both Projects One and Project Two, are focused on the best care possible for Mommy in the postpartum period. And so conceptually, we are using a culture-based model that I forgot to put the slide on, but it is a model that was developed by Collins Airhihenbuwa, who is at Georgia State, which is grounded in culture, the PEN-3 model. And the PEN-3 model basically says, you know, when we're dealing with any culture, any new culture -- and for us, the Delta is a different culture than what we experience in the urban areas -- looking at what are the enablers and barriers of behavior change. The behavior changes that we're talking about specifically now is getting women to, one, be able to have the conversations about mental health, slash mental well-being; and two, what interventions and policies best address the culture and social determinants, local social determinants. And then the implementation strategies -- what specific actions could we use to change the behavior? So that's the framework that we're working from. And of course, this could be couched within the social ecological model, which is in my department, this is a model that we use often. So, when we take a look at the Delta, when we leave Jackson and we're out in the Delta, we have to consider, one, the social services that are actually available in the Delta. That's what that earlier map was about. We have to look at the local politics because this has been an area for years that has been underserved, but lots of money flows in. That's the interesting thing. If you were here, lots of money flows into the Delta, but then we seem to be able to make very minimal changes.

So those of you who know anything about Mississippi know that we are in a place where, historically, I would say, historical grief and oppression, we have to consider all those factors, and it impacts the willingness of women, particularly Black women, to talk about mental health, mental well-being, and definitely, I think someone said it earlier. I think it was Dr. Braithwaite who said, you know, you kind of establish a norm. You think this is okay, that, you know, I shouldn’t talk about it, I should be fine, but we frame it as part of what happens, whether it's your first baby, your second baby, or your third, is that you have to establish a new norm every single time.

And so, when you consider all of the other factors that are coming into play in the Delta, around education, around economic opportunity, around transportation -- major, major issues with transportation -- just getting to your provider in the postpartum care. So, Project One and Project Two is really community care-focused, looking at how we can better make the connections and make sure that within 7 to 10 days that women are discharged from the hospital. We're starting with UMMC in Jackson. Once they're discharged and go back to the Delta, what we're trying to do is reach them in those first 10 days, and actually, the goal is within the first 7 days and begin the postpartum home visits.

The way Project One team has mapped it out -- and there's a lot I couldn't share in this presentation -- is that there will be 3 to 4 visits. Some of it may be done via telehealth. Depending -- We still have some issues with women maybe not being receptive to a home visit, an in-person home visit. So, we are working through those challenges. We roll this out probably in beginning January ‘25. The nurse and the maternal community health workers make 3 to 4 visits, beginning 7 to 10 days after discharge from the hospital, UMMC located.

These women go back, which I said was a 2.5-hour distance from the hospital where they delivered, and all follow-up visits will be conducted through this care team. Home visit two will focus on mental health screening. Very, very important.

I think I heard Dr. Braithwaite, several of you all talk about the importance of being screened, every woman being screened. So, our target group is approximately 500 women over a 3-to-4-year period, and the goal would be to have all of these women screened. And again, part of the conversation with the women will be kind of creating that norm, that mental health screening is okay, and we can talk about it.

The second project shifts a little bit from the home visits to linking women with community support care. So, they're back in the Delta. They're receiving the home visits, and they can then focus in on what we refer to as mommy care postpartum support groups. And this came about because we talked about some of the things that were already happening. I believe several of you all mentioned that, you know, in rural communities. I think, Dr. Braithwaite said, we have so many mental health professionals in Boston. Well, we wish we could have some of those people here in rural Mississippi, or close enough to rural Mississippi. So, we paired up with a young woman who is a therapist who is with the VA. And they had launched a program called Interpersonal Therapy for Women Veterans. Well, we know we're going to have some veterans, probably, that enroll in this study, but not all of them will be veterans. And so, we had a counterpart that was created by one of the nurses who works with us. Walk A Mile in My Shoes. It's going to be a formative research workshop because part of the success of any mental health endeavor in the Delta is getting women to feel comfortable talking about the subject, the awareness level, and then being able to make linkages and referrals to the appropriate providers who they can connect with. Earlier, I mentioned not only accessibility, but there’s also an affordability issue. Many of these women may be Medicaid-eligible, or they are receiving Medicaid, but the appropriateness and a key piece for us is having women accept, accept whoever they are paired with, referred to. That sometimes can be a challenge, and I don't know if I heard anybody talking about that as an issue with mental health providers. So, we have a culture that we have to understand.

So, the title of our postpartum care groups is, "Ain't Nobody's Business but My Own." It will focus on several key pieces to Project 2 maternal health literacy, maternal health, spiritual, emotional. We're kind of trying to integrate those concepts -- trust in the healthcare system, reproductive autonomy, and structuring family support. Those will be online. This will be our first time trying an online model, but we've read enough and seen enough. We know that it will work. I think I heard several people talking about their online postpartum groups, and the key is, if they are not able to join an online group, then we have the option of connecting them with mental health clinics or centers in the community, linking mothers with lifelong mental health facilities.

There are some challenges, but with this counseling support group we will meet once a week, 1-hour duration, 12 months, which is approximately 3 months of the postpartum period. And then we've had some success doing what we call Mom Talks. These are phone conversations, very short, very much directed by the women themselves. I will have a mental health professional that's leading these Mom Talks. They're not structured interviews like we would do in qualitative, but we kind of have some guiding questions that kind of open up the -- “You want to talk about this?” Let's talk about mental well-being as part of the holistic approach to well-woman care.

So, I want to conclude. I think I wanted to bring it to a close with a quote that I use often because I think when you're in Mississippi, it becomes important to realize that we share some common beliefs. And this comes from the former Governor, William Winter, and it simply says, "Wherever I've gone, we can probably agree on these things, irrespective of racial or cultural differences. I've found that people agree on several basic propositions. Everybody wants a decent education for their children. Everybody wants a fair chance to secure a job that will sustain them and their family. Everybody wants to be able to live in a decent house on a safe street. Everybody wants access to adequate healthcare, which includes mental health care, and everybody wants to be treated with dignity and respect."

And I conclude this short presentation with saying, these are the things -- this is the context for what we're dealing with here in Mississippi, and particularly our rural communities. Thank you so much.

MELISSA SIMON: Thank you so much, Dr. Shaw. Dr. Njoroge, you're up. Thank you.

WANJIKU NJOROGE: Good afternoon, everyone, and thank you so much for those of you who've stayed throughout this entire afternoon of really rich conversation. Let me share my screen. Okay.

And let me reduce this. Okay. So as already stated, my name is Wanjiku Njoroge, and I am going to for the next. I'm going to try and shorten my talk a little bit so we can get back on time. But here are my disclosures. And I created some objectives that I think will be helpful as we talk for the next 15 min or so. One of the things I would like to do is really to highlight the criticality of early neurodevelopment. To then, on top of that layer, our understanding associations of race, racism and discrimination, and how those impacts on the mental health of mothers and their young children, and then really think about research, not only during the peripartum period, but also extending a bit beyond and then really drill down into my program research.

Which has been of late looking at this syndemic and its impact on maternal and mental health, and then briefly discuss future directions.

So, you might think -- Ask -- why is there an infant psychiatrist? That's part of this discussion. But I think that if you look at this Dr. Covey quote of begin with the end in mind, it might make a bit more sense, and some of the earlier panelists also talked about this intergenerational or two-gen way of thinking about maternal mental health.

So, one of the things that I worry about as an infant psychiatrist is really what happens in the first 5 years of life, because it's such a critical point in time. And 90% of the child's brain develops during the first 5 years of life. You can see here from this figure all of the systems that are coming online. And when we understand that this is all happening within a larger context or these larger environments in which young children find themselves and the experiences that they have in those first 5 years of life. You can, I think, begin to understand why an infant psychiatrist was invited to be part of this very august panel.

Importantly, we also have heard throughout this afternoon that these experiences really begin in utero and prenatally, and then they extend. We also have heard from some of the early panelists the first panel, really thinking about stressors that can happen in the first five years of life, and we know from Feliti and colleagues, and the work that they did in the eighties and really defining ACEs, or these adverse childhood experiences what this might mean for early childhood development. And we have really broadened those original ACEs to really consider some other things. And for my work, specifically, it's looking at factors of racism as well as parent or caregiver mental illness, and recognizing that if experienced in the first 5 years of life that the sort of hormones that are created really can impact what we would consider to be optimal development and lead to these levels of toxic stress.

So, to put a sort of period to the end of the statement, one of my favorite quotes is from -- we're all sort of sharing our favorite quotes today -- and one of my favorite quotes is a quote from Winnicott, where he said, there's no such thing as an infant. And what he meant, of course, is that where one finds an infant, one also finds maternal care. And so, I hope over the course of the next several minutes I'll be able to convince you of the importance and the intertwining of this intergenerational examination of stressors and health and well-being.

So now that we've sort of covered early neurodevelopment in a sprint. Let's talk a little bit about the impacts of race, racism and discrimination which has already been discussed by Dr. Shaw and clearly in the first panel.

So, we know from a body of research that racism discrimination impacts maternal health. And I think that that has been very clear and has been well reported by colleagues who've been doing work in this space for decades.

When we're thinking about racism, it's really important for us to unpack that there are multiple forms of racism that are operating all the time and simultaneously. For the purposes of our conversation today, I'm going to focus on just two forms of racism that I'm looking at in my own work, which are structural racism and personally mediated or interpersonal racism.

And again, I think at this point in time we are all fairly well versed on these different forms of racism, but I always think it's good that when we're having these large discussions that we start with sort of everyone on the same playing field. So, I've put up two different definitions of the way one may think about structural systemic racism and personally mediated or interpersonal racism.

What's really important about the structural racism piece is thinking about this as these sorts of public policies and institutional practices that were deliberately put into place and that really can be reinforcing and continue to perpetuate racial group inequity. In the same way, personally mediated or interpersonal racism operates very differently in that it can be both implicit or unconscious or explicit and conscious. When we're talking about the very littlest amongst us, it's important to understand how they are impacted by interpersonal racism, and that it can be directly or indirectly and vicariously through their caregivers and their parents.

So, when we're thinking about race and racism specifically, in this peripartum and perinatal period, we've already heard from the earlier talks about what we know when it comes to increased rates of morbidity and mortality for women of color, and particularly for Black women and for Indigenous women. We also heard sadly about the increased rates for Black infant babies’ mortality. And so again, I think that that's an important thing to keep in mind when we're considering the impacts of racism on health.

Similarly, there are these differences that we see in infant and toddler outcomes. And again we heard this from Dr. Brathwaite and others, when we're really thinking about the importance of the in utero experience of this developing fetus, because what the research has begun to show is that the discrimination experience, everyday discrimination that can be experienced by mothers can lead to during their pregnancies, can lead and impact the ways in which their child has these sort of emotionality, consequences, separation, inhibition, consequences at both 6 months and 1 year of age. So let me say that again, since there was a little bit of background noise. Everyday discrimination reported during pregnancy can have long-term consequences on this dyad which we've heard again discussed earlier by Dr. Monk. And that's thinking about this parent or the primary caregiver, and this infant, and the dance that we expect them to do could be impacted by mother's experience during pregnancy. And I think that's a really profound statement when we're thinking about the impacts of racism on maternal health and well-being and clearly of that of infant health.

And though for the purposes of this talk I'm only focusing on the sort of very first years of life. What we know from the research is, not only do these experiences of racism and pregnancy impact mothers and infants and toddlers. But this can extend through the preschool years and even up into early adolescence.

So, we all sort of had a great understanding. We're really beginning to develop this body of research by all of the researchers you've heard today, and many others that have been doing work. And then this happened. And for many of us, as we began to grapple with the pandemic, we began to see headlines, and I started collecting them, because I think it was very helpful for me to begin to really reflect on the ways in which, while we were all experiencing COVID-19. We were experiencing it in different ways. And so, what these headlines and many others reflected, was, there was a disproportionate impact that Covid was having on various communities, and particularly in communities of color. We also began to be very concerned about infants and toddlers and very young people and their development. And what was happening during the pandemic, with a series of cities and schools and services being closed. And we know from the CDC. And the early data that people of color, BIPOC folk, were more impacted with illness, hospitalizations, and deaths, and it became very clear, very early on that, while we were all experiencing COVID-19, we were experiencing it differently. And we needed to think a little bit more broadly about intersectionality and structural and systems, and what that meant for the health of our nation's BIPOC folk.

So, I focused, living in Philadelphia, on structural racism, specifically on redlining. And again, I feel like this is sort of well-trod territory by this point in time, but I still think it's important to really reflect on what was happening in the 30’s and 40’s when the Homeowners Loan Corporation decided to carve up over 230 cities across the United States and grade them with a grade that they themselves created. You can see in the legend here on the figure. And this is a map. This is the original sort of hand-drawn map of Philadelphia. But you'll see that there were 4 grades really from A to D, with the green being the best, and red being the neighborhoods that were deemed most hazardous.

This was important because it meant that development could or would occur or not in particular neighborhoods. And as we've come to know, the neighborhoods that were deemed yellow, definitely declining, or red, hazardous, were neighborhoods where predominantly folk of color lived, and specifically Black folk. And what that meant was that there was disinvestment in those communities in the 1930s which has extended into what we're seeing today, in many communities.

Colleagues at Drexel were doing this really incredible work very early in the pandemic where they created a series of maps. I'm just showing you three of them for brevity. But if you look at these maps, they were looking at where COVID-19 was being most impacted in the city, where the greatest rates of positivity, the greatest rates of illness, the greatest rates of death. They also were looking at the quality of buildings, because at that time we were being told about not sharing bathrooms and not sharing kitchens, and so they were looking at neighborhoods to see who had that kind of flexibility, to have more than one kitchen or multiple bathrooms, if you had multiple family members and multiple generations living in one house.

And of no surprise I'm sure to this audience is that when they layered their maps that they created in the spring of 2020 on top of our original redlining map of Philadelphia, what you will note is that many of the communities that were suffering the most from COVID-19 were those communities that were historically redlined in the mid-thirties. And importantly, those are still the communities where the majority of Black folk live in Philadelphia.

So, let's put this all together, and really think about this when it comes to our population and the families with whom we've been able to work and serve with over the past 4 years. So, the framework that I'm using that we've used is the framework about the syndemic, which really is important because it's an aggregation of two or more endemics in an epidemic condition. This was originally used with respect to HIV in the Black community, with HIV being the epidemic and the endemic being structural racism and factors that were impacting Black folks specifically.

We were able to, with permission from a colleague in Florida. Clarence Gravelee, really sort of adapt a beautiful article that he wrote to think about this endemic as it applied to pediatric populations, and seeing the epidemic as COVID-19 and the endemic as structural racism and other forms of racism, and how that really impacted child outcomes and parent health.

So, we started following a cohort of women very early in the pandemic who were being seen across the Penn health system during their pregnancy. And what I've included here in the next few slides is data on the 2 largest groups of women who participated in this initial online survey, and then who we followed longitudinally.

So, as you can see, the large group of women were Black women and non-Latinx White women. And again, I'm using the term "women" specifically because that is a term that we used when we were recruiting, but we recognize that that term extends to Black and non-Latinx White birthing individuals.

What we found, however, in this initial pregnancy survey was that there were differences between Black women and non-Latinx White women, which again, from the earlier talks, I'm sure, is of no surprise to any of us. But what the Black women reported at that time -- and again, this was April 2020 -- was that they were significantly more worried about their prenatal care, about their birthing experience, and their postnatal needs, which makes sense, considering the rates of Black morbidity and mortality.

They also were very concerned about what the pandemic was going to mean for their economic well-being -- that they may suffer a more lasting burden, and it may indeed affect their employment more so than the non-Latinx White women who participated.

We continued to follow these women through their delivery, and again, we noted substantive differences between what Black women reported and what non-Latinx White women reported. Black women again reported significantly higher levels of distress during their delivery, and they were more likely to fear for their lives and that of their children. Again, considering the research in the literature, this is not a surprise, though concerning in 2020 that this was happening in 2021. They also reported that they indeed were suffering from greater negative effects from the pandemic, and we asked them for the very first time about their experiences of racism, their everyday experiences of racism, and the Black women reported having more of those.

We then looked in the postpartum period at just Black women, drilling down on some of these differences that we’d been finding in the delivery period -- I mean, the pregnancy period -- and just thinking about what it was to be a Black woman during the pandemic at this point in time. And again, as you'll see, we also started to layer on these experiences of racism, for not just interpersonal or personally mediated experiences of racism, and how women felt on surveys about their being treated by the world at large, but also structural factors.

Then we ended up using the addresses of our participants and layering them onto these HOLC maps, as you can see. Maybe a little bit -- the majority of our Black women participants are living still in historically redlined neighborhoods. What we found, importantly, is that women who experienced higher racism, whether it was because of where they were living and their neighborhood factors or their interpersonal experiences of racism, that that, as well with their negative COVID-19 experiences, were associated with a higher increased risk for postpartum depression and anxiety.

And on this slide, I just show you the structural racism factors, and on this slide, I show you the interpersonal racism factors.

So, if we take all of that body of work together, I think what it shows is that racial disparities existed -- we knew they existed prior to the pandemic -- but we certainly saw the ways in which they were profoundly experienced by Black women in our sample through pregnancy, delivery, and even into the postpartum period.

What I also think is important about that body of work is that it really highlighted that we needed to understand more. And we’ve talked about this a little bit in the first few sessions about following up on efforts that we need to understand these stressors more. We need to understand how these racial disparities continue to impact Black women and also how they're impacting their young children.

And that leads to where we are now. I, as well, have been really blessed to receive funding from NIH and NIMH with my study, the Prenatal Preschool Study, which we call P2P. And here, as you can see, I put the aims of the study, and this came up also in the last panel. I think Dr. Braithwaite was the one who stated that it's really important for us not just to talk about risk, but also to talk about resilience. So, that has been a very important part of my research. The other important part of my research really goes back to some of those initial slides that I showed that were talking about the importance of understanding these contexts and these environments in which infants live, and that it’s not just their mothers or primary caregivers, but there may be a system of support. And so, what we tried to do was also include fathers and secondary caregivers in our study to better understand the ways in which this family system was working to support these women and these children.

Then we really wanted to drill down again on the impact of the syndemic, specifically on Black women’s mental health. So, this is just a quick map of our sample at 12 months and 24 months. As you can see, again, this is a much larger sample, and we don’t have the HOLC overlaid here, but it really gives some insight into where our families were living. We didn’t have much movement per se, though we have had some over the subsequent years as we’re really trying to understand this syndemic and its impact on early childhood and maternal mental health.

So, what's next? So, I, like everyone else, am continuing on my work. Our little ones have now just turned 4 in April of 2024, and so we are continuing to follow these families and these little ones, and to really be able to understand how all of the past four years have impacted everyone's health and well-being. And I think when we're thinking broadly about research and thinking about what's next, we have already talked a little bit today about social determinants of health. And I think we're broadening that term. So, people have called it social determinants of health, or structural determinants, political determinants, social drivers. I think all of those things are important when we're thinking about the importance of understanding that it's just not the medical factors that influence health outcomes, but there's a whole bevy of things we need to consider -- considering how people are born, grow, work, live, and age, as well as policies and systems. These political determinants, these economic policies, all of these things impact the health of the families that we see, the communities in which we live, and the patients that we serve.

So again, this is another really outstanding figure by Kaiser, which again speaks to these sorts of social drivers but also talks about racism and discrimination. And that's something that, in the United States at the very least, we need to consider in all of our discussions when it comes to thinking about maternal health and infant health, and specifically when we're talking about historically minoritized and racialized communities.

And so, the last sort of thing that I'll focus on as we're thinking about next steps is really recognizing that there are significant demographic changes afoot. I think we all know from the CDC that we are becoming an ever more diverse country. And so, these kinds of discussions that we're having today are incredibly impactful when we're thinking about being innovative in the future and ensuring that we have optimal development of all young children and optimal mental health of all our nation's women and birthing people.

And the only way this can be done really is through collaboration. And its collaboration across researchers, clinicians, and practitioners, across policymakers, and engaging with families and communities, which we've heard of again throughout today's panelists and speakers. And through these kinds of collaborations, we will be able to make a substantive difference in the future in the health and well-being of our nation's families.

So, this work is done by a massive team, whom I've included here, and I'd like to give a specific thanks as well to our families that have hung in with us over the past 4 years through thousands of survey questions and dyadic interviews, and all kinds of ways in which they've really helped us to better understand how they've been doing and how we might help future generations.

Thank you for your time.

MELISSA SIMON: Thank you so much. Dr. Njoroge. Dr Zivin, you're next.

KARA ZIVIN: Good afternoon. Thank you so much for having me here. I've been asked to talk about both my personal experience as well as my perspective as a health services and policy researcher. So, I'm going to do that. I'm going to skim over some background, since I think we've covered a lot of these topics in depth and share with you some findings from our team as well as some policy-based recommendations.

So briefly here, I also was going to share some personal background. I was very moved by the earlier presentation. So, after struggling with my own moods as an adolescent, I ultimately decided to pursue a career focused on public health and policy approaches to improving access, quality, and costs of mental health care at the population level. I wrote peer-reviewed papers, pursued grants, analyzed data, and gave lectures.

In 2010, I became pregnant for the first and only time after a whirlwind of personal changes in my life, including getting remarried, becoming a stepmother, buying a new home, and pursuing tenure. I wanted to have a medication-free pregnancy and stopped taking antidepressants. Although I look happy in these pictures of my late pregnancy and early motherhood, my smiles hide the pain and anguish that I experienced.

First trimester insomnia led to depression and anxiety as my pregnancy progressed, leading me to a place of desperation and suicidality. In 2011, during my eighth month of pregnancy, I took an overdose of multiple medications and woke up two days later in a hospital. Like others have expressed earlier, I too had the belief, excuse me, that my family would be better off without me.

I spontaneously went into labor the next day and gave birth to my son. He ended up in the neonatal intensive care unit, and I was transferred to the psychiatric ward. He was discharged four days later, and I followed him three days after that. But when continuing to remain ill for many weeks after my discharge, I made the difficult decision to undergo electroconvulsive therapy. I have almost no recollection of that period, including the first few months of his life, which is a known side effect of ECT.

As I've heard presentations here and elsewhere about the advances in care since 2010, I note that if I was pregnant now, in the same circumstances that happened, it might have turned out very differently with the advent of new medications, which are really encouraging. And so, it's really challenging to talk about these topics. You know, you're continuously reliving some of the worst moments of your life. But I think it's really important, because even though, you know, I've recovered after an uphill climb to returning to health and becoming a mother, I also recognize that it's still important to talk about these issues.

So, I think we've covered in previous talks a number of risk factors for pregnancy and postpartum. And I'll just add that I'm really fully aware that if I had a different skin color, educational attainment, financial circumstances, marital status, employment status, insurance coverage, zip code, or even year of delivery, the outcomes for my son and me could have been substantially worse.

So again, we've covered topics such as the prevalence of perinatal mood anxiety disorders as a major public health outcome, leading to a number of negative outcomes both for mothers and families, and a leading cause of maternal mortality. We've talked about the depression treatment cascade, noting that very few people get treatment and through remission.

Some work I'd like to highlight that I think is somewhat unique from my team and yet has really received a lot of attention over time is that we were asked by several foundations to estimate the costs of untreated perinatal mood and anxiety disorders, which we estimated at $14 billion dollars, with a “B”, in 2017 from a birth cohort from conception to five years postpartum, or for the mother and child dyad to $32,000. We've looked at this in a number of states, with different modifications, including California, Washington, Colorado, Texas, and Vermont, where a number of mothers are funded through Medicaid. We've also started to look at cost savings of these conditions with access to things like perinatal psychiatry access programs. By the way, all of the references I note here will be cited at the end and in the slides available to you after this talk.

So, I want to pivot now to talking about some of the empirical work that my team has done to be at a societal level, using a variety of large data sets, including administrative claims from private and public insurance, as well as large surveys. One of the analyses we did look at increasing trends in suicidality during pregnancy and postpartum, where we found that Black and lower-income individuals experienced larger increases. We also found that individuals with perinatal mood anxiety disorders had higher risks of having a C-section than those without perinatal mood anxiety disorders.

We found that those with perinatal mood and anxiety disorders had a higher incidence of severe maternal morbidity, increased hospital transfers, lengths of delivery stays, and other delivery-related costs compared to other deliveries. We've also looked at outcomes for infants, noting that mothers of infants with neonatal intensive care stays had higher odds of mental health diagnoses than mothers whose infants did not have these stays. Non-white individuals had a higher probability of interrupted health insurance or uninsurance during the perinatal period. And recently, we published this work looking at a sample of privately insured childbearing individuals from all 50 states, where we observed a 93% increase in perinatal mood and anxiety disorders between 2008 and 2020. While we saw that psychotherapy rates increased, so did suicidality after the implementation of the Affordable Care Act in 2014. Perinatal mood anxiety diagnosis rates began increasing, and so did psychotherapy. But fortunately, suicidality rates began to decline.

Here I wanted to show some work we did specifically looking at the Mental Health Parity Addiction and Equity Act that was passed in 2010 and implemented in --- sorry implemented in 2010, and the ACA, that was implemented in 2014. We looked at both the cost -- sorry, the use of psychotherapy as well as costs. While there's a bit of detail and nuance in these figures, it's just to say that these policies had mixed effects on access to care, which demonstrated complementary and complex impacts of policy change. But, as you can see on the left, rates of psychotherapy increased relative to what might have happened had these policies not been changed, whereas evidence suggests they went down on our right-hand side.

Here I wanted to talk about a different study that we've done looking at mortality using CDC data from the National Violent Death Reporting System. We found that mental health conditions, substance use, and intimate partner problems represent important precipitating factors for completed suicide. This is using data from more than 1,100 women who died while pregnant or during a year after birth, with their deaths listed either as suicide or as an undetermined cause. We compared these to almost 18,000 individuals aged 10 to 50, who did not have a pregnancy in the last year. This work suggests that pregnancy is an important transition period where preexisting factors can contribute to suicide risk, in addition to social, psychological, and biological risk factors associated with the perinatal period itself.

Here I wanted to highlight, over the past almost two decades, a variety of different policies, and of course, there are others that influence access to care and outcomes for perinatal mood and anxiety disorders. For example, here we show that states were only required to start screening for depression not that long ago, and many states still don't have a requirement to screen. I've already mentioned mental health parity, and there are other acts, some that have been funded and others that have not. More recently, we've seen that a number of professional organizations and government sources have been recommending more screening and providing opportunities for Medicaid expansion to cover individuals not just for the first 60 days after delivery but for one year. Many of these factors may influence both the diagnosis as well as treatment and outcomes for perinatal mood and anxiety disorders.

Here we had a number of policy recommendations that we've talked about in bits and pieces throughout the day. Just to highlight several for you, one of the areas we know is that care can often be quite siloed, between OBGYN, mental health, and sometimes primary care. If we can have better communication and coordination across specialties, I think that would be one way of helping, including incentivizing whole-person health, not just your mind versus your body.

I think it's important to enhance insurance coverage. Most states now have extended Medicaid coverage, but not all have done so. Also, trying to consider alternative payment models that would encourage coordinated and high-value maternity care. It's important to measure outcomes. There are a number of quality measures that we use across different conditions, but very few are focused on either mental health or obstetrics and gynecology, or the intersection of those two. Yet, what we measure drives what we do.

We've talked about workforce shortages, both in terms of maternity care as well as mental health care. More than 2 million individuals of childbearing age live in what people call a "maternity care desert" with no access to obstetric care or birth centers. We really need to address these needs.

Finally, stepping beyond the clinical realms, it's really important to think of the broader social context. For example, implementing paid parental leave and universal childcare would also go a long way towards addressing mental health needs and supporting both childbearing individuals and their families.

So, circling back to my own experience, this is actually from 18 months ago. Now, my son is 13, and he's several inches taller than me. But I highlight some successes that he's had in his life. And yet, none of that would have been possible, obviously, if I had not survived my experiences with perinatal mood and anxiety disorders.

As we've talked about with the really stunning examples we heard earlier, others are not so fortunate, and maternal mortality rates continue to rise. Yet, they exclude discussing and counting mental health and substance use conditions -- so overdose, suicide, interpersonal violence -- and any statistics that you might hear about maternal mortality rates really are a substantial underestimate of the true population burden, not to mention the substantial racial disparities that exist.

I wanted to acknowledge my team as well and our various studies funded by the National Institutes of Health. You'll again get a copy of all these different references if they interest you. And here's some contact information. I just wanted to put in a brief plug while I have the floor. I have written a personal narrative, including both data and my personal story as a book-like manuscript. If anybody is interested in talking about this further and helping me get this out into the world, I'd be very grateful. So, thank you, and I look forward to our discussion.

MELISSA SIMON: Thank you, Dr. Zivin. That was fantastic. Thank you for sharing your story as well. Dr. Sheth, you're up. Thank you.

NIMA SHETH: Hi, everyone! Good afternoon. Thank you so much for having me here. Get my slides going.

All right. So, I'm gonna talk a little bit about the National Maternal Mental Health Strategy that we released this past May. So, I have had the privilege of working on this task force now for over a year, and we were tasked by Congress to create a strategy to improve the state of maternal mental health in the second year, and a report to Congress in the first year. But our task force was so ambitious, and there was an ask from our leadership to actually expedite the strategy so that we could capitalize on all of the momentum and the initiatives and the passion that we have right now in the Federal Government on this particular topic. So, we were able to work to get the strategy out a year in advance, and I have to say just a thank you to the task force for those of you that were on. We met over 40 -- over 40 meetings -- in just a matter of a few months. We met that many times. We had amazing co-chairs of various work groups, and today I'm going to highlight, specifically, the ones in the research and data subgroup. But just want to start with that.

We've had -- we had a number of -- I’ll cover the participating agencies and folks. It's just such an amazing, diverse task force. We have over 120 folks on the task force, both Federal and non-federal, and I'll cover a little bit about the report to Congress highlights. And then, like I said, I'll do a deep dive into our Pillar 3, which is the research, data, and accountability pillar. And then we'll review some next steps. And you'll have to forgive me, I have the fall viruses from my two little kids, so I apologize if my voice goes in and out, or if I am coughing in between.

So, these are the participating Federal agencies. I think what we're really proud of here is that it's not just folks across Health and Human Services. We also have people across the Federal Government. So, we have, you know, Department of Labor, we have Department of Defense, Department of Homeland Security. We really have tried to be very comprehensive in the reach and collaboration across the Federal Government here. This is a list of all of the participating non-federal entities. So, just a lot of great minds in rooms together, I think, has been part of the success of the work of the task force so far. So, also just want to take a minute to say that the work of the task force and the strategy is built upon existing work in the Federal Government, a lot of which you've already heard. But there's also some initiatives here that we really want to highlight. This is not comprehensive by all means, but there's just so many amazing things that are going on in the Federal Government that this initiative has built on, and these things continue to kind of work together. You know, it's really a cohesive effort.

So, I'll briefly cover the report to Congress highlights. It's about six chapters. We present -- see, so the way the task force is structured is it's a subcommittee of a FAC, or a Federal Advisory Committee that is within SAMHSA, the Advisory Committee for Women's Services. And so, all of the documents and the writing, and all of that, is technically product of the FAC, which makes it a really unique task force because these are not technically Health and Human Service documents. They're FAC documents, which gives us the ability to have a lot of input and flexibility in what we say, and a lot of input from the public, which is exactly what we did.

So, we have a chapter in that report to Congress that talks about the background and statistics and prevalence -- all of which you've heard today, so I won't repeat. We also -- Congress asked for a kind of a list of best practices from the task force, so what the task force put together -- they're kind of top two to three from each kind of area or sub-area of the congressional language that included like screening, prevention, diagnosis, treatment, community-based practices, intergenerational approaches, dyadic approaches -- and we put together a chapter of best practices that the task force considers in all of those different realms and areas.

And then we put together a whole list of all of the Federal programs related to those services. Every committee work group that we have that coordinates work on this topic, all of that was included in this one chapter. So, it's a really good reference chapter. If you ever have questions of what this agency is doing with regards to perinatal, you know, mental health and substance use prevention or treatment, it’s really comprehensive in that way.

And then we had four listening sessions with state and local government stakeholders and partners, and it was kind of the start of what's going to be our report to Congress, or report to -- of Congress -- from governors. Essentially, a report on governors on perinatal mental health and substance use that we'll be doing in 2026. This is kind of a little bit of a primer for that. So, we had some listening sessions, and we put in the overarching themes and results from those sessions in this particular chapter. And so, that's kind of what the report to Congress comprises. If you have a chance to look at it, it's really comprehensive.

And I'll spend the rest of the time delving into the National Strategy itself. So, the vision of the strategy is that, you know, we have the perinatal and mental health and substance use is integrated across medical, community, and social systems, and that we really try to reduce this distinction between mental and medical care, and that care is, you know, there when you need it, at the right time, in the right place, and delivered in the right way according to one's culture, and that's trauma-informed.

So, the audience for the strategy is the Federal Government, however, and there's really -- the Federal Government, right, can't do its work without collaboration and partnerships across the board with all of the stakeholders, also includes, like you, as well as other folks that are on the task force. So, although it's speaking to the Federal Government and the different entities within the Federal Government, like Congress, the Executive branch, and the agencies, it really is talking about all of us collectively -- how we could come together to do this work across public, private entities, industry, and medical professional societies. And if you were to see that list of the folks, I said that are on the task force, you'll see that all of those different sectors are represented there.

And so, what's emphasized is that we have a whole-of-government approach. This is an image that captures -- excuse me -- this is an image that kind of captures all five of our pillars and recommendations. If you notice, all five of the pillars are aiming up at whole-person and dyad perinatal mental health and SUD care. So, we really maintain that as the focus. And I won't read the pillars because we're going to go through them a little bit more in depth. And on the outside is our trans-cross-cutting, trans-strategy principles: equity and access, Federal collaboration, trauma-informed and culturally relevant care.

So, I'm going to briefly cover the other pillars, and like I said, I'll do a deep dive into Pillar 3. Pillar 1 is all about building a national infrastructure that prioritizes perinatal mental health and well-being. We have multiple priorities under each pillar, and then each priority has multiple recommendations. Under each recommendation is a "why" section, and then a "how" section, and the how section starts to lay the groundwork and a little bit of a roadmap for how to obtain that particular recommendation, like what are some really concrete steps that we can take.

So, this first priority, 1.1, is to promote really integrated perinatal mental health and substance use models of care that have a focus on mother-infant dyads, and they have multidisciplinary, interdisciplinary teams. So, it's really a lot about integration across all of our systems. But then priority 1.2 is establishing and enhancing policies that focus on, you know, promotion and also a reduction in disparities. Some examples of recommendations in this pillar, for example, are to create -- to have a federal law on at least six months of paid family leave, guaranteed universal childcare, embedding childcare more in healthcare settings so that people can go to their appointments and have childcare. There's also a recommendation on recognizing and reducing historical trauma and structural racism, and there's a really strong recommendation that goes more in-depth there. As you've already heard from the wonderful presentations ahead of this, how important and how big of a role racism plays in perinatal mental well-being.

So, those are the examples of some of the types of recommendations that are in this pillar. Pillar 2 is all about making care and services accessible, affordable, and equitable. Our three priorities here are to implement culturally relevant and trauma-informed screening, diagnosis, and linkages. This priority has recommendations that talk about how to improve screening across the board, have more integrated forms of screening, and then that linkages piece -- so in the referral -- so people don't get lost. We also know that screening is more than just asking questions, but it's really about education, it's about building rapport, it's about creating a safe space and how that can be done. Wherever possible, we call out models -- across the board you'll see throughout the strategy there’s all kinds of models that we call out, whether they’re Federal or non-federal, and we call for those models to be scaled up and spread. So, we do talk a lot about specifics here.

Priority 2.2 we’re talking about accessibility and integrated care that's affordable and reimbursable. So, here we do talk about increasing reimbursement, like Medicaid reimbursement, and in all states where it's possible, we talk about improving reimbursement for all payers across the board -- so commercial as well as Medicaid. We also talk about care that is more patient-centered and flexible, where you know, evening scheduling or home-based care, improving telehealth infrastructure so we could bring care to more places that don’t have it, like in rural settings. So, we talk a lot about that. And then 2.3 is focused all on workforce. There are about four core recommendations here that talk about how to expand federal programs that are enhancing workforce, how to expand the diversity within the workforce, and then how to improve training both from the technical assistance perspective of training that’s offered from the Federal Government, but also curricula -- national curricula for all the various disciplines within behavioral health. Social work, psychology, psychiatry, counseling, and making sure that this topic is a core part of that curriculum. So, that’s also what goes into priority 2.3.

Okay, so here’s Pillar 3, and then we’ll get into each recommendation. Our two priorities within Pillar 3 are using data and research to support strategies and innovations that improve outcomes, and then building a foundation for accountability, prevention, screening, intervention, and treatment.

The first recommendation in Priority 3.1 actually calls for this beautiful national research agenda. So, it’s to establish an interdisciplinary, interagency expert panel to determine high-priority areas of research, surveillance, and implementation science that will directly affect national improvements in perinatal mental health conditions and substance use disorders. The expert panel would be charged with ensuring coordination across the Federal Government, translating data to action, and monitoring and sustaining research and surveillance in this area. So, in the how section, there’s actually a national research agenda that is starting to get proposed, and there are some example topics of the types of things that national research agenda would focus on. So, that’s the first recommendation here.

The second one is all about both looking at the harms that research has done historically to various populations, and rebuilding trust in these communities, and also calling on more perinatal populations to be part of research. So, it’s investing in ways to build trust of under-resourced communities who have experienced past abuses, and a lot of those abuses are outlined in the why section of this recommendation. And it’s really calling on engaging communities, namely pregnant and postpartum people, and ensuring that research, data collection, analysis, and reporting are equity-focused, representative, culturally relevant, and maintaining confidentiality protections, and of course, the highest ethical regard for under-resourced and vulnerable populations. So, this is our second recommendation in this bucket.

Also, still, within Priority 3.1, we have a recommendation around supporting and funding integrated data systems by sharing data across healthcare and community services, of course while preserving confidentiality. This is so we could use data to inform and drive the development of more equitable policies and effective practices and improve outcomes, ultimately. So, this gets a little bit more into data sharing.

And then 3.1.4 is talking about building a central clearinghouse of information so that it’s accessible to all across providers, public health, and government officials. And it’s kind of accessible at fingertips to be able to use and have central resources for perinatal health. But it’s a central clearinghouse of data collection programs.

3.1.5 is to pair implementation guidance and dissemination strategies with research findings, scientific findings, and surveillance findings. So, it’s -- when new research comes out -- giving guidance to folks on how to -- what the uptake of those findings looks like, how to roll out particular recommendations and clinical guidelines. So, it’s really implementation and dissemination support that we think, you know, there’s still a gap around right now.

And then our three recommendations within our second priority around accountability have a lot to do with quality improvement. So, 3.2.1 is to establish and implement QI metrics for providers, hospital systems, and insurers, and have multi-year longitudinal tracking of costs and outcomes. And then creating mechanisms to ensure the implementation of those evidence-based solutions. There are some more specific examples, again, that are given in the how section for that.

And then in recommendation 3.2.2, we call on fully funding and expanding support for perinatal quality collaboratives in all 50 states, because we're not quite there yet. And then in 3.2.3, we do have MMRCs in all 50 states, but the task force thought it was really important to call out, to continue to fund all of those, because we don't, you know, it's not guaranteed that they would continue sustainably.

Okay, so that's our Pillar 3. Pillar 4 is to promote prevention and engage, educate, and partner with communities. So, this is all around primary prevention strategies at the community level. We do call on specific models that we think have worked, like PREP or Centering Pregnancy. And then, think about models like the HAIR model that came out of the University of Maryland, or others that could potentially be adapted to be brought into the primary prevention realm.

And then 4.2 is about elevating education of the public and engaging communities with outreach. So, a little bit more communications-focused, and they do think about things like national campaigns, like the postpartum depression campaign that we have out right now. Could we do more things like that to engage and educate communities?

Pillar 5 is all about lifting up lived experience. Really proud of this pillar. It was accomplished through our colleagues at US Digital Services that did a separate research sprint of folks with lived experience as well as providers. And there is a basically set of recommendations that came out of this research sprint that have all been matched up with recommendations from the task force. That did not happen on purpose. They happen to very naturally align, and there's a table in the strategy that actually talks about what their recommendations are, along with the task force recommendations, and talks about the alignment, which is really interesting.

And then there are quotes from the research sprint that are all throughout the report to Congress and the National Strategy that really support the recommendations.

And so, what do next steps look like? This year, we're really looking at planning and implementing the recommendations that we now have out, because there's a total of 29 recommendations. It doesn't mean we're going to be tackling all 29. A lot of them are kind of in process as well from work that has been started even decades ago. But we really want to take a look at some concrete new things that we can do to also reach those recommendations, to really put them in motion. There are also annual updates to the report to Congress and the National Strategy. So, every year Congress is called on for an annual update for both documents. So, we'll continue to do that. In FY26, like I said, we'll have the report to governors, continued focus on implementation, and again with the annual update, so that might mean a change in the recommendations, or revision of recommendations, or potentially an expansion of scope.

These are some of the current implementation activities. We are going to be having -- and currently have -- a federal and a non-federal co-chair that are leading each pillar of the National Strategy in terms of helping to track and push implementation of those recommendations. We have built out an implementation tracker that is going to outline action steps and partners and ideas and all of that. And then we have federal agency actions that will be tracked in that tracker.

We want to support any Congressional action that would be taken. We are exploring public-private partnerships. We are in conversations with many folks around private sector commitments that would be announced hopefully sometime in January through the White House, and then the private sector commitment calls are going to be going out in September. And then we have continued partnership with states and local government, and the rest I think I've talked about. So, this is our contact information, and that's it. Thank you so much for your time and looking forward to discussion.

MELISSA SIMON: Thank you so much. All right, Dr. Sheth, that was great. I'm going to invite all four of our panelists back on. Again, a very powerful panel with really important data and research, but also thank you for sharing your personal stories, Dr. Zivin. That takes a lot of courage, and it's important to be able to see how this is all weaved together -- like the clinical care, personal story, community efforts, the policy right from SAMHSA, etc., and the research, and how research can help drive a lot of this together.

And so, what brings me to these questions is, it clearly takes a collaborative effort across all the sectors, right? Research, government policymaking, community partners, people with lived experiences, academic institutions, etc. And I'm wondering, in what ways will such collaborative efforts really help improve pregnancy-related mental health outcomes? Like, what should we be doing starting tomorrow -- or really yesterday, if we could -- to move the needle forward to push these collaborative efforts more, because this is what makes us all healthier. Anyone can jump in.

KARA ZIVIN: Right. I've been, you know, following some of the -- not just the national strategy that we've just heard about, although I think that is a really, really important step and just represents a ton of individuals and thought leaders about a wide range of topics related to perinatal health. But also, you know, the White House blueprint. You know, there’s been a number of initiatives where it's clear that people are paying more attention. Of course, we always need more resources to implement all of the recommendations, you know, including trying to incentivize more providers, because having more access to care through, you know, better insurance coverage only works if you have enough providers to actually give the care to people who need it. So, those are just a few thoughts I've had on that topic.

WANJIKŨ FM NJOROGE: I agree. I mean, I think clearly, resources are important. I think that we also need to think a little bit more innovatively about where we're getting these resources, right? And so, we need to start including insurance companies in these kinds of conversations, recognizing that they're paying for folks to get higher levels of care, or if we'd spent money on prevention, then that may at the end of the day have not only saved these families, these young children, but also the system itself from the stress that it's under.

So, I think that there are ways for us to be innovative. Folks are doing it, and they're showing it's effective, but it really does -- it's really important that we are engaging everyone in these discussions. I think, you know, in years past, we weren't necessarily having everyone at the table. I think the research that's been presented today has really very clearly shown that everyone's engaging with community partners in a true way, having them at the table from the very beginning and being part of these discussions. It's only through that authentic engagement and resources that we can really move the needle.

MELISSA SIMON: Thank you. And you know, in order to get to that real authentic engagement and true collaboration, you need trust. And Dr. Shaw, you had to get a lot of trust in Mississippi. Can you tell us, like, you talked to us a little bit about trust and how to garner that? Because it’s not just with the people -- the pregnant and birthing persons and the people on the ground experiencing this -- it’s with community. It’s across policymakers, academic institutions, clinicians, etc.

MARY SHAW: So, let me try to give some response to that.

MELISSA SIMON: It's a hard question. I apologize.

MARY SHAW: Loaded one. But that's okay, because I need everybody to know that one, I'm not a Mississippian, so I'm an outsider. I'm from Texas, and that has made it even more difficult for me now on the team and with our partners. What we've tried to do is -- most of the people are from Mississippi. I am probably the transplant leading the initiative. But one of the things that's been critical for me, based on a lot of work that I did in my early years of my career, is understanding the culture. Okay? So, to gain trust first. And what I found in the Delta, and I think my colleagues and partners, if they were here with me, they would say some of these same observations, but trust in the Delta has multiple levels. So, there's trust among the people themselves. Remember, these are counties and communities that have been marginalized. Oppressed. It is one of the most underserved areas in Mississippi. So, getting people themselves to trust each other -- okay, that's one level. And then there is the trust with the provider system. And then there is -- I think I would be safe in saying that probably the trust level is highest among those community-based organizations, the presence, because there is a different kind of dynamics and interaction than with the healthcare system. With the healthcare system, and I always say -- and I know I got a lot of mental health people on here -- perceptions are real, and you have to deal with them, whether they're true or not. I can't remember who did the presentation about the birthing experiences during COVID-19. We had a study that was done here in Mississippi, and I think probably many of you know we were one of the states where it was very difficult to get the uptake of the mandated practices -- wearing the mask and getting the immunizations and everything. So, trust was a major issue. Did they trust the healthcare system enough, even though there were conflicting messages coming from outside of Mississippi? That was a big one.

But one of the things that I have learned in working with the communities, the five counties that we're working with in the Delta, is that I had to rely on the local individuals to help me better understand the culture, the cultural norms, which is the perceptions that people have about -- and we can say mental health perceptions, whether it is the woman or her family. So, in the Delta, the networks are so, so tight. And so, the trust issue begins within the communities.

Let me just kind of depart a little bit. So, the first time I went to the Delta was back in 2017, and I’m in this meeting, and we were talking about transportation issues to get to your appointment, okay, to get to your doctor’s appointment. And one of the things I questioned was two things. One was the use of -- there are a lot of churches, and the churches have vans, and this came up more recently in a meeting, and the churches use vans to transport people. But my question was, can those vans not be used to transport women to their appointments and to the hospitals? Right? And so, it was a different issue that came up, which was liability.

Okay. The second issue was, I thought, well, this be a great opportunity for Uber or Lyft to come in and help bridge some of these connections? Well, I was totally not aware of the culture and issues that are deeper than what I was thinking. And so, I would say what we’ve relied on are those individuals, those community-based organizations, those individuals that live there who give me context for understanding something deeper than what I’m looking at, if that makes sense to everyone. It’s so critical for us.

So, as we’re trying to deal with this mental health piece, clearly in any rural community -- I think having, in Texas, having had a mother who grew up in a rural community -- the conversations around mental wellness, mental health, are almost taboo. Okay, it's a very difficult -- it's okay to talk about this. So, we have depended also on the women. We have several levels. One is creating the awareness, the comfort level to be able to talk about mental health, not only for yourself but beyond yourself, okay, in that neighborhood, in that community. And so, that's what the workshop is about. One of the workshops is about. We did one about two years ago, dealing with Mom and Baby Excel, and there was a session on mental health. And what does that look like? But trust: What does it look like? What does it feel like? What does it sound like for the woman? But then, what does it look like, feel like, and sound like for the provider? And the congruence is what we're looking for -- trying to be able to communicate what would trust look like. Because we use that a lot, all of us do. But what does it really mean? And maybe in the Delta, it has a different meaning based on our history of racism and oppression than what it would somewhere else. I don't know. That’s what we’re trying to find out.

MELISSA SIMON: Thank you. I appreciate that answer. I know that one of the audience members was asking around the issue of mandated reporting for abuse and neglect. And from our experience, it's about being transparent about what are the boundaries of what you can and cannot report, and what you have to report, all of that, and it is about first garnering that trust and being very upfront.

MARY SHAW: Trust.

MELISSA SIMON: Right.

MARY SHAW: Yes.

MELISSA SIMON: So, I have a couple of other just very quick questions. One is, there is an audience member that works for NAMI in Ohio, and they're wondering if they can -- they're trying to start a support group for maternal mental health, and they want to know what screening tool to use for postpartum depression. And you know my experience is PHQ-2 to a PHQ-9 is relatively easy and has multiple languages translated in it as opposed to the Edinburgh. But anyone else have experience?

NIMA SHETH: It's just a couple of things on maybe all of what's been said so far. I think I want to get to the screening question, but also the reporting versus notification, and that we're working a lot around, you know, plans of safe care and with particular states, especially through the Secretary’s Collaborative on Maternal Health and Mortality.

And I think part of it is also your clinical competency of understanding how to assess for abuse versus neglect, versus none of the above, and understanding that addiction is an illness. Because most states right now will say you have to report even if it's just present, and I think we don't have standardized implementation of plans of safe care across the board. There are some, and so the key, I think, gets back to your first question, Melissa, as to what we can do now is we need to lift up models that have worked. We need to spotlight the models that work, like there’s plans of safe care that our task force brought up in Alaska that are doing this really, really well. How do we lift up that model for the other states and help give training to clinicians to understand when you actually report, when you don’t, how do you make a notification without a report to get that family the help that they need? And then I think the screening piece around this is also important because if you're in a non-clinical setting -- and I understand from their question it’s not a clinician that is doing this, they’re not medically trained -- I’m not sure you want to use a clinical screening tool because that can also -- it depends on the resources that are going to be available for that individual. So, if they answer yes to the last question on the PHQ-9 around crisis and suicide, what do you have set up? Maybe you have systems set up to address it, which is great, but it’s sometimes appropriate and sometimes not unless you are trained to provide the support and care that’s needed in the peer space and in the support group space it’s very appropriate to inquire and talk about these things, but it’s important to note what is a clinical intervention and what isn’t. And so, I think that sometimes also thinking we need to use formalized screeners to assess, provide support, and understand what’s going on is also a problem. It’s a barrier at times. A lot of times -- I’m a trauma specialist -- when I work with trauma, I don’t always use the screener. First, I just talk about their life and what is going on right and what is going well for them and where they want to see things go better. And I think starting with those open-ended questions and building that can be the foundation for a support group. I would not actually recommend starting with a clinical screener in a support group like that.

DR. MARY SHAW: I agree.

MELISSA SIMON: And so, having referrals in place though, if something were to happen during the support group, or something was identified, having referrals in place for the “what if” somebody is experiencing suicidal thoughts or being harmed, etc., it's important to have that before you start that support group.

NIMA SHETH: And two quick plugs: There’s the TLC MAMA Hotline that HRSA has, a maternal mental health hotline, so quick plug for that, and also SAMHSA’s 988 hotline. Both of those are definitely -- you know what could be called. But to tell someone, “Well, you just said this, here, call this number,” I mean, it's not so simple, right? So, if you're going to do that, make the call with them, stay with them, or connect them to a local crisis support system. I don’t think just handing them the number is sufficient, but I think they are good resources.

MELISSA SIMON: Yeah, I agree. Warm handoffs are important. All right, Dr. Zivin, you had just put in the chat that you did a study that compared the different screening methods -- PHQ-9 and the Edinburgh Depression Scale -- and you found they were equivalent for screening.

There was one more question about screening for anxiety. Somebody experienced getting fine scores, negative or normal scores, on the depression scales both mentioned, but is there something for anxiety screening?

WANJIKŨ FM NJOROGE: So, I put into the chat, the GAD-7 is something that we've been using in our studies and that we use in our clinics because it's similar to the PHQ-9 in that it's only seven questions. So, the burden on families to complete these kinds of questions isn’t so intense. And again, there's quite a bit of data about it being very helpful. But you know, I guess I would say the same thing that Dr. Sheth was saying in that -- forgive me if I'm mispronouncing your last name -- but that we use it a lot in both our clinical practices as well as in research. But there are plenty of other tools which might be more appropriate depending on the audience.

So, I think again, it goes back to making sure that when you're thinking about using any kind of measure or any kind of screener, that it's in the languages that will best serve your population, that it takes into consideration that there are differences in the way in which we experience these mental health challenges and the way we talk about these challenges, and so that some measures may be more reflective or give the opportunity to reflect in different kinds of ways. And even though they might be a bit longer, they really will get to the concerns at hand. So those are the caveats I would put around the GAD-7.

MELISSA SIMON: Thank you. And again, there are warm handoffs and referral patterns in place to get people to that next step, because it is a journey, right? Just coming to a support group or coming to a community organization or a clinic or somewhere, and you find that somebody needs some connection to something -- to the next step in that care journey, that mental health wellness journey -- and that has to happen somehow. So, really important to think through all of that.

NIMA SHETH: I would agree with the GAD for more formal screening. And I think, but I think it's starting -- because we're getting a lot of questions on screening. I'm seeing, I think, starting the screening process with a focus on resiliency, right? Like, what's going right for you versus like, what's wrong with you, right? Because it's already like, being a mom is so hard. Pregnancy is so hard. There's so many feelings of guilt and shame that we experience as mothers all throughout our journeys. And I think that, and so it's really following that trauma-informed approach.

I teach a lot, and I always tell the students, yes, these clinical screeners are important. They tell you something, and measurement-based care is also important where you come back to measures and look at assessment and follow-up. But I think that having those initial conversations around, you know, like, tell me how you're doing now, where do you want to be, what’s different? Potentially, with some of those comparative questions like, what’s different about the way you cope with things now versus when you were feeling better in the past? Asking some of those comparative questions helps them reflect.

And then starting with, what have you been doing well, that you feel like you've been doing well, right? And it gives you insights on their strengths and coping strategies, and where some of the problems might be. It gives you a lot more insight than just a simple screener. And I think the screeners have to be paired then with that kind of art of interview style. But I just want to say that that piece is important and starting with a focus on resiliency.

MELISSA SIMON: I completely agree. Well, I need to close this panel because we’ve run out of time and went over a little bit. Thank you so much for your time and talks today. They've been remarkably helpful and extraordinary and thank you all for the work that you do. I am going to transition us to Dr. Dana Meaney-Delman as the discussant. She is the Chief of Infant Outcomes Monitoring Research and Prevention Branch for the US Centers for Disease Control and Prevention. So, take it away. You have the extraordinary task of summarizing today’s amazing, powerful panels and discussions. Thank you.

DANA MEANEY-DELMAN: Thank you so much. Well, I’ve been listening here, and I just have to say it’s just been an amazing roundtable discussion, a fantastic moderator, just learned so much. So, I’m going to pull up some slides, and you all can feel free to edit or make suggestions because I’m sure I didn’t capture everything. I did my very best, but I’m sure I didn’t capture everything, so I just need to -- A lot of things on my screen right now -- let’s see if I can get to -- Can you see the summary of the Round Table? Yeah, can anyone see this?

MELISSA SIMON: All good, yes.

DANA MEANEY-DELMAN: Okay, wonderful. Thank you. Okay, so as I said, my name is Dana Meaney-Delman, I actually work at the CDC, and as you’ll see here, I do have some disclosures. The biggest one is that I served as the co-lead with Nima for the Data Research Quality Improvement workgroup for the National Strategy for Maternal Mental Health. So, I was involved in that, and thank you for summarizing that so well, Nima, really appreciate it. And for all the work the whole task force has done to raise this issue up to much, much higher levels.

I also want to acknowledge that I am a very, very strong proponent of bringing together experts, and I think this is a perfect example of that -- from across the Federal Government, academia, and women with lived experience from diverse communities -- to, as all my mentors have told me, address and not admire the problem. I think we’ve spent many, many years -- and I can say I’ve spent many years at the CDC where we’ve really admired the problem by looking at data and chopping it up into different ways to look at the data, but not actually addressing the real-world problems. And I think the National Strategy and this Round Table really has moved us forward in trying to truly address those problems.

So, here’s some of the things I heard in our landscape of maternal mental health. I want to thank NIMH and the Office of Research on Women’s Health for bringing us together. But it’s really clear that maternal mental health disorders are common, are increasing, and are untreated, and we need a broader focus than just postpartum depression. I think this just came out in the last talk about how do we screen for anxiety? I think there’s been -- as an OB-GYN, I can tell you -- a disproportionate focus on depression. But we’ve left off postpartum psychosis, anxiety, intimate partner violence, and some of those other things.

And we all agree, we’ve been overly reliant on research in men, and I think there is the tip of an iceberg. There’s a lot of initiative now, including the White House Initiative, including the National Strategy, that is providing opportunities for innovation, creating centers of excellence with NIH solidly in the lead here, and we very much appreciate that, and love collaborating with SAMHSA, Office of Women’s Health, and NIH as we move this forward. It really is going to take all of us to do this. The bad news, as we heard, is that there are disproportionate risks among the younger generations of women, and this concerns me for my two daughters, and clearly a disproportionate impact on Black women and on socially disadvantaged women. And that’s something we need to not continue to admire, but to actually address.

There’s broader recognition of the social determinants of health, including economic and social stressors as a component of mental health disorders. Again, I still think there’s a tremendous amount of work we need to do to actually address some of the social determinants of health that impact these disorders. I’ve really appreciated this term “syndemic,” where we recognize the disproportionate burden of mental health disorders as well as the intersection with systemic and intergenerational racism. And this really -- I think this term in my world at CDC has often been applied to infectious diseases, but I think it’s perfectly applicable here and raises it to a level I think that hopefully will generate more buy-in, more resources, and more understanding that we are talking about complex intersecting issues that need to be addressed from multiple vantage points.

Exciting new drug discoveries, some with faster activity, but I think there’s much more to learn -- not just about drugs but also about combined interventions. And it seems like we still need a better understanding of the placebo effect, which I think Melissa pointed out really well. That has been seen in many studies for a long time and, you know, I think needs to be really dissected a bit more to really fully understand. You know, what can we glean from that aspect of our research arms? Maybe it’s not necessarily about the drug. What are we doing in that aspect of research and providing more voice or more support to women who are suffering?

Trauma and intergenerational trauma in particular are now recognized risk factors, compounded by family, community, and the mass societal trauma of the pandemic. So, prior to this, I don’t think I had that concept in my head that was shown to us earlier today, where we have the individual, the family, the community, and then the mass societal trauma that, I think, is not just applying to the pandemic but is applying to many different parts of our lives.

I had a few webinars light bulb moments. I like to use this term. These were things that were brand new to me. Having worked in this space for a long time, you may have had others, but I did not realize that postpartum depression is more inheritable than general depression. That is something that I think is very actionable, and something I have not been asking my patients about, so that was of extreme interest to me. I knew these new medications were focused on the GABAnergic pathways, but I thought we really understood it a little more than we do, so that was interesting to me. And I expect that maybe we’ll have more drugs that will target that pathway as time goes on, and hopefully ones that will be well tolerated and will have faster recovery because I think waiting the six weeks or the four weeks it takes for some of our patients to feel better is just way too long for new moms.

I talked about being in a trial. I didn’t realize as much of the placebo effect, but I think that’s really interesting and why it warrants more discovery. The two-generational impact -- I’ve heard Dr. Monk speak before, but each time I’m so impressed that we really have been diving into maternal stress and trauma, and the impact not only on mothers but also on their offspring, without it being in a blame or guilty way, where we’re putting the blame on women. We’re really, I think, demonstrating these inherent stressors, the inherent concerns that really need to be addressed to improve the health and wellness of the mother just as much as the infant. So, I applaud you, Dr. Monk, and others who are really addressing it from a holistic dyadic approach.

And then the intergenerational racism. I don’t think I quite had an appreciation for the real long-term impact that has on families. So those were some of my personal light bulb moments that hopefully you have some as well.

I saw some low-hanging fruit that I feel like is important to call out -- things that I think we could address right now with not a lot of resources. And that includes better identification of women at risk, so better understanding of the specific risk factors, whether they be ACEs or genetics or the social determinants of health, and really incorporating that more into provider training and to even order sets that could exist within IT systems where we know this is a risk factor. It’s an identified risk factor, and therefore that warrants an immediate referral to a social worker, to services that may exist, or maybe even to a mindfulness intervention. I think we saw the wonderful work with mHealth as a preventive option for Black and Latina women, and I think that could be expanded, and mindfulness in general could really be expanded. I personally talk to patients very often, even while they’re pregnant, about using some of the apps that exist around mindfulness and really getting into a good sleep routine so that when the baby comes, they prioritize their sleep and wellness, since that is so critically tied into mental health.

And then, as Nima mentioned, I think this 1-833-TLC-MAMA is a very underutilized hotline. I know we talked a lot about access to care. This hotline allows providers to call and identify with the individuals on the hotline and a place for our patients who are experiencing mental health disorders or symptoms to be connected directly to providers who are accepting patients. There are still major issues around insurance coverage, but at least it's a warm body handoff, and I think that's really important.

What wasn’t mentioned -- and patients can also call TLC Mama as well, so it doesn’t have to be just the provider. What wasn’t mentioned on this webinar, but I thought would be important to pull out, is that there also is a HRSA teleconsultation program, which is for providers, and it’s only in 11 states. But I know they’re hoping to expand this where providers who may not feel comfortable treating substance use disorders or providing SSRIs or other options can call and get assistance.

I can tell you, as an OB-GYN in a practice, I still have some reticence by many of my residents in terms of prescribing SSRIs and getting comfortable even with very safe drugs and longstanding drugs like Wellbutrin. I think it’s been demonstrated, and the beautiful work in Mississippi demonstrates the benefit of community engagement in research and in implementation. So, in translating that research into changes in people's lives, that was just a beautiful example and one that I think many other states and jurisdictions could learn from.

We do need to improve cultural responsiveness. So, it’s one thing to have CBT programs, but it’s another to make them accessible and also make them culturally appropriate for the patient population who may be experiencing very different stressors than others that may have been seen the day before, or even the hour before, in a mental health clinic. And then, of course, Nima and others have been working very hard on executing the National Mental Health Strategy. So, it’s wonderful that we have a maternal mental health strategy, but now we need to execute it. And this needs to happen across the US government, academia, community-based partnerships, and also with our nonprofit organizations who are advocates in this space.

In terms of the path forward, I heard quite a bit. There’s a lot we still need to do. So, I think the biggest thing that occurs to me is that we still have not fully incorporated perinatal mood and anxiety disorders into the medical home and into health IT. There’s still a lot more to be done. It still feels like it’s separate from physical health. And really integrating that as part and parcel of health and wellbeing, I think, is critical. And that means bringing more mental health providers directly into clinics and making them more widely available.

I think the wonderful research that NIMH and others have funded is really paving the way. And we need that research to be more rapidly translated into evidence-based practice for all women, children, and families. And I think we see these great examples, but I’m not sure yet that we have the implementation mechanism to take these wonderful studies and have them be available for all women across the nation. That’s a real hope that I think we can realize together.

We’ve seen some proven effective models of innovative care, and again, using those models, bringing them to jurisdictions and ensuring that those jurisdictions have appropriate payment to sustain these models and elevate care for all women -- not just for women who have, you know, the fancy private insurance or are in an integrated healthcare plan. So that’s a real challenge for us, and I think it’s going to take more work with the insurance companies. As someone said towards the end of this webinar, I think that’s really critical -- demonstrating to them economically that these prevention strategies or these early intervention strategies, in the long run, are going to be less costly for them. So, I think it’s important that we bring in those insurance providers sooner rather than later.

And then, as we talked about before, the widespread availability of targeted, culturally appropriate interventions, and marrying those with comprehensive strategies that enable women to seek and maintain care and health and wellness. That means childcare, leave policies, electronically available teleconsultation, and those sorts of things. So that, you know, women who have very, very busy lives can access and maintain their care, and when other things come up in their family, they are still able to prioritize their own health and wellbeing, both for themselves as well as for their families.

We need faster drug discovery. We need an evaluation of combined regimens. So, I still think it’s easier for me to write a prescription than to find a place for my patient to get counseling, and I think we need to really look at that paradigm shift. And that means we need to expand the workforce. I think we heard that loud and clear. We need more mental health providers, and for them to be integrated into our clinics.

I heard loud and clear that CBT needs to be adapted to address cultural differences and to specifically address the social determinants of health. Some of those cannot be changed by the individual. And so, we also need to be thinking about policies. And this is where the National Strategy and the White House blueprint try to look at strategies at a higher level, because an individual cannot necessarily change their social determinants of health themselves. And yet, we know it’s contributing to their overall health and wellbeing.

Towards the end, we heard about incentivizing providers to increase the workforce and to improve access. So that means perhaps -- I wasn’t exactly sure what people were getting at -- but to me, it means getting providers to go into the field and making it easier and more streamlined for them to go into the field, but also paying them, you know, to see patients at a reasonable rate so that they continue to want to stay in practice full time and in specific resource-poor settings.

We clearly heard the loud and clear need for additional resources, whether it be to support the strategy, for more research, for more implementation science, and again, including perhaps some of those resources coming from insurance companies. Clearly, we are already demonstrating continued collaboration across different domains, but that genuine collaboration -- I think that’s what you said, Melissa -- that genuine, authentic collaboration where everyone really is working toward the same goal, I think, is key.

And then this was a big theme, and I think it’s really important to acknowledge what has happened in our country and to improve trust with patients, community clinicians, and academic institutions. And the only way to do that is to, again, stop admiring and really address the longstanding health inequities in our country in mental health, but really across the board.

I want to steal Dr. Zivin’s policy recommendations because I thought these were right on. None of this is going to happen without changes in policy. So, these were five amazing instructions that I think we could all rally around to make sure we have coordinated care -- and again, that goes back to integrating into the medical home, to enhance the insurance coverage, to make sure we’re measuring outcomes. So, what may have worked in Mississippi, or may have worked in Boston, or may have worked at UNC, may not necessarily work in Atlanta, Georgia, where I practice. So, we need to be sure that as we implement strategies that are evidence-based, we adapt them for the community that we’re serving.

We must address our workforce shortages, and I really wholeheartedly agree that the majority of the burden right now for childcare, for duties in the home, still falls to women. And unless we get paid leave and paid childcare, women are always going to be struggling until we can really have a true 50/50 sharing of household responsibilities.

And then some good news. This just came out September 9th, so take a look at it. I put the link down at the bottom. The Biden-Harris administration is lowering mental health care costs by improving access to mental health and substance use. And you can see here, they’re really using this prior act, the MHPAEA -- that’s a hard one to say -- to make sure that the health plans are requiring -- excuse me -- making meaningful changes, so that they have meaningful reimbursement, meaningful insurance coverage for mental health services. Whereas before, we’ve talked about how unless you have the top-tier best insurance, even then, there’s still an out-of-pocket expense. So, this is, you know, preventing denying pre-authorization and making it very clear and regulating what the health care plans should be doing and making it clear to the individuals they are insuring what they are covering and what they are not covering upfront.

I think I heard a statistic that even those with private insurance -- many of them have to go outside of their healthcare plan to receive mental health coverage. So, we still have a major, major problem, and that’s for the most insured -- not to mention those who are minimally insured in this country, which still, unfortunately, the underinsured makes up a pretty significant portion of our population.

So, with that, hopefully, I captured some of the main themes. I could go on for hours because it was a really amazing webinar, but I’m really honored to be here and to be a discussant with you. And so, I believe I’m turning it over to Dr. Lauren Hill.

And thank you all for your incredible presentations and for this wonderful webinar. I think we had over 500 participants at one point. And this is being recorded, so I think this is a very huge step in the right direction and a continuation of the path that I think we’re all on to improve mental health and prevent mothers from dying and families from experiencing negative consequences for mental health disorders and substance use disorders. So, thank you all. Dr. Hill.

LAUREN HILL: Thank you so much, Dr. Meany-Delman. Can you all see me?

MELISSA SIMON: Yes, we can see you.

LAUREN HILL: Okay, fantastic. I’m going to wrap it up very quickly here. What a fantastic, fantastic workshop and webinar. So, I’m just going to offer a few words of thanks and then wrap us up. I’m Lauren Hill. I’m the Deputy Director of the NIMH Office for Disparities Research and Workforce Diversity. And I’d like to thank all of our incredible and expert panelists today, and to extend a special appreciation to our experts who shared their personal experiences with perinatal mental illnesses. Your stories, experiences, and authenticity were powerful and very generous and reminded us of our common humanity, that research and clinical care are human endeavors, and the work that all of us do matters in people’s lives.

In terms of NIMH or NIH, you all know that we have a research mission, but there’s absolutely no way we can reach our public health goals alone. We are going to benefit from the whole-of-government approach that my colleagues spoke about, Dr. Ota Wang, and then also Nima Sheth. At the end of the day, we’re going to benefit from that approach. It is large, it is complex, but so is this problem. These challenges that we talked about today, we need the entire research enterprise. We need academia. We need investigators, trainees, mentors. We need the pharmaceutical industry. We need policymakers. We need public and private payers. We need innovators. We need creatives. We need healthcare providers, community members, community-based organizations, families, and patients in order for us to address this problem.

Research matters only when it informs practices and policies that generate solutions or interventions that are accessible, and that people will also utilize. And that’s only part of the work. There are many parts to play.

So, in conclusion, to our attendees and our very distinguished panelists: thank you all so much for whatever part you play in this endeavor, for the contributions you make to this important work, and we look forward to continuing to work with you as we address the very complex and very challenging undertaking of improving perinatal and maternal health for all. Good afternoon.