NAMHC Minutes of the 261st Meeting
September 15, 2020
Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Mental Health Council
Introduction
The National Advisory Mental Health Council (NAMHC) held its 261st meeting at 9:00 am, September 15, 2020 via Zoom and NIH Videocast. In accordance with Public Law 92-463, the session was open to the public until approximately 1:30 pm, and closed thereafter for consideration of grant applications. Joshua Gordon, M.D., Ph.D., Director of the National Institute of Mental Health (NIMH), presided as Chair.
Chairperson
Joshua Gordon, M.D., Ph.D.
Executive Secretary
Jean Noronha, Ph.D.
Council/Ad Hoc Members Present
- Laura Almasy, Ph.D.
- Marjorie Baldwin, Ph.D.
- Randy Blakely, Ph.D.
- David Goldstein, Ph.D.
- Ian Gotlib, Ph.D.
- Alan Greenberg, M.D., M.P.H.
- David Henderson, M.D.
- Kamilah Jackson, M.D.
- Lisa Jaycox, Ph.D.
- Cheryl King, Ph.D.
- Gregory A. Miller, Ph.D.
- Yael Niv, Ph.D.
- Neil Risch, Ph.D.
- Elyn Saks, Ph.D.
- Brandon Staglin, M.S.
- Joseph Telfair, DrPH, M.P.H.
- Sophia Vinogradov, M.D.
- Hongkui Zeng, Ph.D.
Department of Veteran Affairs
- Amy Kilbourne, Ph.D., M.P.H.
Department of Defense (Ex Officio Member)
- Captain Chad Bradford
Liaison Representative
- Anita Everett, M.D.
Others Present at the Open Policy Session (Others Roster)
Open Policy Session Call to Order & Opening Remarks
Joshua Gordon, M.D., Ph.D.
NIMH Director, Dr. Joshua Gordon, opened the second virtual videocast NAMHC meeting by expressing his thanks to all Council members, especially those on the West Coast, who are dealing with time zone differences and challenges from the ongoing wildfires. Following introductions, the Council passed a motion approving the final Summary Minutes of the May 19, 2020 meeting and the Summary Minutes of the August 2020 closed Council Session.
NIMH Director’s Report
Joshua Gordon, M.D., Ph.D.
Congressional Interactions with NIMH and NIH
Dr. Gordon updated the Council on recent NIMH congressional activities, all of which have occurred virtually in light of the COVID-19 pandemic. These activities included the House Energy and Commerce Committee briefing on the impact of COVID-19 on stress and mental health on May 26, 2020, and a briefing on neurodegenerative diseases and mental illness on May 29, 2020. On July 20, 2020, Dr. Susan Borja, chief of the NIMH Dimensional Traumatic Stress Research Program, and staff from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefed Senator Kirsten Gillibrand’s (D-NY) office on NIMH-supported research related to the pandemic. On July 29, 2020, Dr. Gordon participated in a Congressional Neuroscience Caucus briefing on mental health during COVID-19. He noted that Congress is particularly interested in suicide prevention, especially among Black youth. On September 3, 2020, Dr. Gordon met with Representative Bonnie Watson Coleman (D-NJ) and members of the Congressional Black Caucus Emergency Task Force and Working Group to further discuss efforts to address mental health disparities.
Dr. Gordon also provided an overview of Congressional interaction with the NIH as a whole. On June 30, 2020, the House Committee on Energy and Commerce held a hearing titled “High Anxiety and Stress: Legislation to Improve Mental Health During Crisis ,” which covered many topics and pieces of legislation of interest to NIMH. Additionally, Dr. Francis Collins, director of NIH, testified on July 2, 2020, before a hearing of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies titled “Review of Operation Warp Speed: Researching, Manufacturing, & Distributing a Safe & Effective Coronavirus Vaccine .” On September 9, 2020, Dr. Collins testified before the Senate Health, Education, Labor, and Pensions Committee in a hearing titled “Vaccines: Saving Lives, Ensuring Confidence, and Protecting Public Health .”
Appropriations and Budget Updates
Dr. Gordon explained that the House passed a number of acts, including the Health and Economic Recovery Omnibus Emergency Solutions Act , to provide supplemental appropriates in response to the pandemic, including funding for NIMH and NIH to conduct COVID-19 research and to offset costs caused by pandemic-related logistical disruptions. Dr. Gordon reviewed the fiscal year 2020 budget, which is just over $2 billion. This budget enabled NIMH to support an estimated grantee success rate of 24 percent, despite a continued increase in the number of applications submitted and funded.
COVID-19 Update
Dr. Gordon provided an update on NIH-wide efforts related to the COVID-19 pandemic. One of these initiatives, which began in May 2020, aims to support research to understand the social, behavioral, and economic impacts of COVID-19. He anticipated that $25 million in selected supplements will be distributed across NIH to support this effort in the coming weeks. The second initiative is Rapid Acceleration of Diagnostics - Underserved Populations (RADx-UP) , for which NIH has received nearly $1 billion from Congress to develop and speed the application of testing for COVID-19 with a focus on minority and underserved populations. In addition, NIMH has directly responded to the pandemic including efforts to disseminate information on coping strategies, promoting mental health, and the importance of testing especially in minority and underserved populations.
NIMH News to Know
Dr. Gordon announced that the NIH-wide Accelerating Medicines Partnership (AMP) program now includes psychiatry. The AMP program seeks to establish public/private partnerships in the precompetitive space to identify and engage targets for the treatment of disorders. NIMH has partnered with AMP on a schizophrenia-focused project, which will generate tools to develop early-stage interventions for individuals at clinical high risk for developing for psychosis and schizophrenia. Core components of the AMP Schizophrenia (AMP-SCZ) project include the establishment of research networks in the community and a data processing, analysis, and coordination center. Currently, three pharmaceutical companies and four non-profit partners have signed on to the project. Dr. Gordon highlighted the participation of NIMH’s divisional leadership—Dr. Sarah Lisanby, director of the Division of Translational Research, Dr. Bob Heinssen, director of the Division of Services and Intervention Research, Dr. Linda Brady, director of the Division of Neuroscience and Basic Behavioral Science, and Dr. Greg Farber, director of the Office of Technology Development and Coordination —as integral to the success of these partnerships.
He also discussed efforts within the NIH, NIMH, and extramural communities to fully understand the impact of system racism and mental health equity.
Dr. Gordon said that he will continue to Chair the Interagency Autism Coordinating Committee (IACC). Although the IACC is currently on hiatus, the 2018-2019 Strategic Plan Update was published in August 2020.
Dr. Gordon briefed the Council on NIMH staff and leadership news. With great sadness, he announced the passing of Dr. James Jackson, a former NAMHC Councilmember, and acknowledged the passing of Dr. Fred Goodwin, a former NIMH Director. He recognized Dr. Kathleen Anderson for her transition from Deputy Director of the Division of Translational Research to Director of the Division of Extramural Activities at the National Eye Institute (NEI). He added that he and Dr. Linda Brady received the Rona and Ken Purdy Award for Distinguished Service from the National Alliance of Mental Illness.
Individuals in the NIMH Division of Intramural Research Programs have also received numerous awards. Dr. Gordon highlighted Dr. Leslie Ungerleider, who received the Glass Brain Award from the Organization of Human Brain Mapping, and Dr. Peter Bandettini, who received the Gold Medal Award from the International Society for Magnetic Resonance Imaging in Medicine.
Dr. Gordon announced a national search for three NIMH leadership positions and encouraged interested applicants to visit the USAJobs website or to refer their colleagues.
Last, Dr. Gordon discussed the ongoing campaign focused on NIMH from individuals and groups who cite concern for animal welfare. Dr. Elisabeth Murray, a distinguished NIMH investigator whose work with animal models has advanced scientific knowledge of human mental illness, has been the subject of serious attacks, harassment, and threats from animal rights activists. These individuals have also impacted the larger NIMH community by submitting numerous Freedom of Information Act (FOIA) requests to impede scientists’ ability to carry out mental health research. Dr. Gordon expressed his full support for Dr. Murray and for all other mental health investigators who have been targeted by these campaigns.
NIH-Wide Updates
Dr. Gordon welcomed the five new institute directors who have joined NIH: Dr. Rick Woychik of the National Institute of Environmental Health Sciences (NIEHS), Dr. Shannon Zenk of the National Institute of Nursing Research (NINR), Dr. Michael Chiang of the National Eye Institute (NEI), Dr. Lindsey Criswell of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and Dr. Rena D’Souza of the National Institute of Dental and Craniofacial Research (NIDCR).
He noted that Dr. Hannah Valantine, who has been a key advocate for diversity in the workforce and equity in research, will resign as Chief Officer for Scientific Workforce Diversity at NIH at the end of September and congratulated her on her retirement. Dr. Gordon also congratulated Dr. Jean Noronha, Director of the NIMH Division of Extramural Activities, on her upcoming retirement. He highlighted some of her achievements and wished her luck in retirement. Dr. Noronha thanked him and said that she has cherished her time at the NIH.
Dr. Gordon briefly updated the Council about the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative , which held a successful virtual meeting in June, and the All of Us Research Program , which recently announced plans to leverage its diverse participant base to seek insights on COVID-19. He added that the Adolescent Brain Cognitive Development (ABCD) Study will release more data this year.
Science Highlights
Dr. Gordon shared three science highlights. The first highlight was a collaboration between Dr. Vikaas Sohal and Dr. Mark Schnitzer of the BRAIN Initiative, who are working together to use modern technologies for the analysis of neural activity, specifically as it relates to mental illnesses. Using cutting-edge technologies to adapt human learning tasks to study rodent neurobiology, Drs. Sohal and Schnitzer determined that gamma oscillations in the cortex enable different regions of the brain to communicate across structures, which may play a role in encoding working memory, learning, and other cognitive functions involved in mental illnesses.
The next science highlight was work from Dr. Joseph Levy and Dr. Zindel Segal, who are working to adapt cognitive therapy procedures to a virtual context. They administered an online cognitive behavioral therapy (CBT) course to individuals with mood disorders, finding that people who engaged in online CBT showed faster, longer-lasting improvements compared to people who received standard care.
Finally, the Division of AIDS Research has been supporting research to understand the role of the nervous system in perpetuating HIV illness. An ongoing study has examined HIV in a hybrid mouse model with human tissues to determine if HIV in the brain can escape into peripheral systems. They found that when a mouse brain is transplanted with HIV-infected human astrocytes, HIV leaks from the brain and infects CD4-positive cells in the periphery. These findings highlight the need for efforts to eradicate HIV from the central nervous system.
Discussion
Mr. Brandon Staglin expressed his excitement to see discussion of Dr. Sohal’s gamma study. He noted that stimulated gamma synchrony enabled mice to continue rule-shift learning long after the initial stimulation, and wondered if this effect is preserved in the current research. Dr. Gordon said there may be a psychological explanation, but they need to follow up with physiological markers.
Dr. Randy Blakely congratulated NIMH staff for their work on the AMP program and asked if the partnerships are working on other mental illnesses underrepresented in clinical research and therapeutics, such as bipolar disorder. Dr. Gordon said their primary focus in the prior years has been to discover drugs for serious mental illness. He also reported that they had made more substantial investments in schizophrenia than in bipolar disorder. Dr. Gordon clarified that the focus of drug development will be on clinical high-risk individuals with an emphasis on schizophrenia. He noted that the AMP paradigm enables them to study other disorders (e.g., Alzheimer’s disease, Parkinson’s disease, diabetes) and that there is the potential to use this model for underrepresented conditions such as bipolar disorder.
Dr. Marjorie Baldwin also commented on the AMP program and thanked the partners on behalf of the community of families and individuals who have schizophrenia. She was also pleased about the award from NAMI and asked about efforts to broadly publicize this initiative to researchers, families, and communities. Dr. Gordon said that NAMI is one of the nonprofit partner organizations of the AMP program, and there are many efforts to publicize the initiative, including blogs and press releases.
Dr. Sophia Vinogradov pointed out that although the AMP program contains the word “medication” in its title, medications may not be the only treatments developed for targets investigators identify. She said that some online methods useful for other disorders might also target important cognitive processes that could be conjoined with molecular and network targets. Dr. Gordon agreed and said they would welcome additional partners who take different treatment approaches. He highlighted NIH Blueprint for Neuroscience Research (NIH Blueprint) , a group of Institutes, Centers, and Offices at the NIH who pool funds to support cross-institute neuroscience initiatives. Recently, Blueprint published an initiative to identify targets and develop compounds and devices that engage those targets at the molecular level.
Mr. Staglin agreed that non-pharmaceutical treatments would be valuable for the AMP project and expressed hope that multiple AMP projects could collaborate on schizophrenia and bipolar disorder given the genetic, behavioral, and symptom similarities between the two conditions.
Special Council Review Discussion
Dr. Gordon briefly discussed the Special Council Review (SCR) process, which permits additional awards to investigators who have more than $1 million in direct research grant support. The policy ensures that research dollars are not concentrated in too few hands at the detriment of early-stage investigators or those at risk of losing their funding. More recently, the SCR process has aimed to improve the diversity of scientific approaches used across the NIH portfolio.
He noted that all but two of the applications for NIMH funding reviewed since 2017 were approved. These results indicate that NIMH staff are skilled at deciding which applications require SCR to express interest, as any application deemed below the top 10th percentile of excellence is not presented for SCR.
Recently, the SCR focused on several different factors, including the quality and strength of science, investigators' productivity, and the potential impact of the science. While this approach has benefits, Dr. Gordon pointed out that they may not be taking advantage of the opportunity to use these resources to fund early-stage or at-risk investigators. The National Institute of Neurological Disorders and Stroke (NINDS) takes another approach, which involves setting more stringent pay lines for applications from well-funded investigators, establishing a specific score that an application must reach to receive funding. Dr. Gordon said that a strict pay line may work for NIMH and that they may consider requiring applications that qualify for SCR to score in the 10th percentile or better to receive a high-priority designation. Using this approach, 18 of the applications considered by NIMH since January 2017 would not have met the criteria for funding. Well-funded investigators would need to pass a higher bar to receive additional grants, requiring both productivity analysis and peer approval of the application.
Dr. Blakely said that this approach, which would require strict advanced planning, may diminish investigators’ flexibility. Dr. Gordon said that some exceptions could be made with regard to timing.
Dr. Cheryl King asked if there is a measure of how familiar investigators are with the SCR policy, and how much weight they give the policy in their decision to apply. She suggested that a more stringent policy may show favorable outcomes by encouraging teams to appoint junior or mid-career investigators to project leadership roles. Dr. Gordon agreed and asked Dr. Noronha to speak to investigators’ familiarity with the policy. Dr. Noronha replied that there is a continual flux of grants beginning and ending, and investigators may be unable to predict if they will reach the $1 million funding criterion by the time the Special Council receives their application. She added that NINDS released a notice when they instituted their policy to ensure broad awareness among investigators.
Dr. Yael Niv asked about the possibility of a more stringent threshold or potential postponement of grant funding by one year. She also asked if the budget for multi-Principal Investigator (PI) grants includes funds that go directly to their lab. Dr. Gordon and Dr. Rebecca Wagenaar-Miller said that the budget for shared grants is split evenly. Dr. Niv disagreed that this is not necessarily the case and noted that a senior PI might take 5 percent of the grant money rather than a larger portion; thus, this hurts all junior PIs receiving mentorship from the senior investigator. Dr. Wagenaar-Miller said that all investigators must be listed for SCR. Dr. Gordon said that they could make exceptions to the rule or create a policy that accounts for these concerns.
Dr. Vinogradov echoed Dr. King’s comment about the importance of fostering junior investigators, and noted that some senior investigators may be hesitant to do this because junior investigators lack an established track record. She said that peer reviewers would need to change their team evaluation strategies to ensure that teams with junior or mid-career leaders are not disparaged. She also asked for outcomes data on the NINDS policy. Dr. Noronha said that NINDS initiated this policy in January 2019 and more information may be available from the NINDS staff member who manages that program.
Dr. Ian Gotlib suggested that NIMH should build in overlap time for funding an investigator when funding is set to expire in less than six months.
Dr. Laura Almasy emphasized the importance of flexibility and said it would be useful to have a guiding rubric.
Mr. Staglin expressed support for motivating original ideas by distributing NIMH funding to investigators who are not already funded.
Dr. Neil Risch commented that the current system tends to fund proven investigators, but peer review is a meritocracy and the process may not be fair and equitable, especially for junior investigators and underrepresented minorities. He said there is a need to create policy that encourages objectivity via stricter rules and rationales.
Dr. Alan Greenberg recommended a decision-making process that uses qualitative and quantitative data from the large sample size of highly-funded investigators. He asked what would happen to funds saved by the policy, wondering if they would be funneled back to junior and/or minority investigators.
Dr. David Henderson agreed that guidelines should be changed, and investigators should be educated about the new policy. He agreed with Dr. Risch that some aspects of the process lack objectivity.
Dr. Gordon thanked Council for their input and said that he will bring some of the data that were requested and consider bringing a representative from NINDS for future conversations about the SCR policy.
Concept Clearances — Part 1
NIMH Mental Health and HIV/AIDS Research Centers (Reissue)
Christopher Gordon, Ph.D., Division of AIDS Research
Dr. Christopher Gordon presented a reissue of the HIV/AIDS Research Centers, a longstanding mechanism sponsored by the Division of AIDS Research that uses the P30 Infrastructure Core Mechanism Awards. The full AIDS Research Center is capped at $1.5 million per year for five years, while the Developmental Center is capped at $750,000 per year for four years. They fund centers focused on behavioral and social sciences, as well as neuro-HIV centers. The mechanisms support an administrative core, a developmental core, and two to three other cores with expertise in faculty mentoring and services geared toward scientific priorities. Currently, these priority areas include research on pervasive inequities, multilevel causes and solutions, biomedical advances in treatment and prevention, and emerging issues in neuro-HIV.
Discussion
Dr. Greenberg said that this work is an important complement to the Center for AIDS Research (CFAR) program, which is supported by NIMH in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) , the National Institute on Drug Abuse (NIDA) , and multiple co-funding Institutes. He reiterated that the four high-priority research areas are health disparities, improving uptake of proven HIV prevention and treatment strategies, implementation science, and central nervous system dysfunction and mental health outcomes in persons living with HIV.
Dr. Amy Kilbourne said she appreciated the focus on implementation science and encouraged them to expand this into community-based research. She suggested adding another priority area for research related to the comorbidities associated with HIV and mental health, particularly cardiovascular disease.
Dr. Noronha called for a motion to approve the concept. A motion to approve was passed.
Strengthening HIV Prevention Efforts among Women in the Southern U.S.
Susannah Allison, Ph.D., Division of AIDS Research
Dr. Susannah Allison presented Strengthening HIV Prevention Efforts Among Women in the Southern U.S., an initiative focused on supporting research to increase awareness, uptake, adherence, and persistence to HIV prevention strategies among women in the Southern U.S. She noted that cisgender women represent one in five new HIV infections in the U.S. each year, and an estimated 14 percent of transgender women currently live with HIV. The majority of these women are African American or Latina, and women living in Southern States account for about half of all new HIV diagnoses. The initiative aims to address dimensions of stigma, class, race, sex, and other important factors that play a role in HIV risk and services access. The initiative would encourage research in three areas: implementation science, communication research, and services research.
Discussion
Dr. Lisa Jaycox expressed her support for this concept and suggested that the statistics on HIV risk among women could be presented more clearly when the concept clearance is announced. She also noted that implementation science and services research overlap, and Dr. Allison might clarify the differences between these focus areas for the benefit of applicants.
Dr. Greenberg suggested clarifying the exact proportion of cases and rates of HIV among women in the South. He said it might be helpful to articulate how this concept relates to the HHS Ending the HIV Epidemic initiative , particularly among women in the 57 Ending the Epidemic hotspots, many of which are in the South. Last, the initiative may consider specifying priority HIV prevention interventions.
Dr. Allison concurred that data should be clearer in terms of specific HIV incidence rates among women in the South. She also agreed about overlap in the three buckets and suggested a full request for applications (RFA) would need to comprehensively specify the specific types of work encouraged under each focus area.
Dr. Noronha called for a motion to approve the concept. A motion to approve passed.
BRAIN Initiative Overview
John Ngai, Ph.D.
Dr. John Ngai, director of the NIH’s Brain Research through Advancing Innovative Neurotechnologies ®(BRAIN) Initiative, provided an overview of the BRAIN 2.0 phase of the NIH BRAIN Initiative® , a large-scale effort to accelerate neuroscience through the development and implementation of technologies that will improve the study of brain signals. To achieve this goal, there is a need to continue leveraging technology to enable new discoveries about neural circuit function, to use these discoveries as a foundation for new therapeutics for human brain disorders, and to focus on disseminating and democratizing these technologies for basic discovery and clinical applications.
He explained that the BRAIN Initiative was announced in 2013 and launched in 2014 by a working group of the Advisory Council to the Director of the NIH. They issued the BRAIN 2025 Report , which informed directions for the BRAIN Initiative over the next decade, including keeping on a productive path, emphasizing behavior and the power of model organisms, balancing individual investigator-initiated research with team science, and supporting large-scale projects that transform neuroscience research and the treatment of human brain disorders. Dr. Ngai focused on the last of these points, reviewing awards made to the BRAIN Initiative from 2014 to 2019. Dr. Ngai focused on the last of these points, reviewing awards made to the BRAIN Initiative from 2014 to 2019. The Initiative has base funding, which is generous, yet uneven, from the 21st Century CURES Act , and will result in a large increase to $810 million investment in the fiscal year 2023.
To take full advantage of this increase in funding resources, the Initiative has developed a series of BRAIN 2.0 transformative projects that aim to expand the solid foundation of discovery and technological innovations developed over the last decade. The first of these transformative projects is Phase 3 of the Brain Cell Census, which will build on the success of the BRAIN Initiative Cell Census Network (BICCN) and shift focus from mouse brain towards building an integrated human brain cell atlas—a “parts list” for the brain. The project relies on methods such as single-cell RNA sequencing and single-cell epigenomics such as methylC-sequencing to learn more about each cell type’s anatomy, connectivity, and function within neural circuits.
Dr. Ngai provided a brief background of the BICCN, one of the largest, most organized consortia within the BRAIN Initiative. It centers on three large U19 awards that generate and analyze data, as well as a series of smaller U01 awards focused on analytical techniques, technological development, and coordination. He highlighted four collaborative studies from U19 and U01 investigators across multiple sites. First, they determined if they could conduct an integrated analysis based on data generated from multiple RNA sequencing and epigenomic platforms. They used spatial transcriptomic to place the identities of those cells into their anatomical positions and patterns within the laminar cortex. Then, they used the Patch-seq technique to patch-clamp recordings from individual cells, obtaining information about cell physiology by sequencing RNA. The study was extended into nonhuman primates and humans, and the results suggested that nonhuman primate and rodent brains show significant conservation in cell types, and that mouse brains may be adequate analogs for larger brains.
The second of the transformative projects is the development of next-generation technologies for performing brain cell microconnectivity analysis. The project aims to create a wiring diagram of the whole brain at multiple scales and potentially across species. Together with the Brain Cell Census, this project will reveal information about disease-relevant cellular and neuronal components of brain circuitry. Thus far, they have developed powerful imaging modalities to visualize activity within neural circuits in awake animals. Dr. Ngai emphasized the importance of looking at dynamic maps, which will increase understanding of the brain’s information traffic patterns.
The last project is to develop resources for gaining access to cell types in the brain for monitoring and manipulation. Dr. Ngai explained that they refer to this project as the “cell-type specific armamentarium,” the creation of a large toolkit to gain access to cells, both in rodents and in other model organisms that are less amenable to transgenic and germ-line analyses. Eventually, they aim to adapt these strategies for the human brain. To do so, they aim to access cell types in somatic cells using viral and non-viral vectors that could target both research and therapeutic applications. Dr. Ngai discussed the importance of democratizing these technologies. Although many new, exciting gene therapies have been launched, these multimillion-dollar trials may be prohibitively expensive. He proposed that the “modular toolkit” would reduce cost and enable investigators to apply a certain therapy or certain gene editor using pre-validated components, reducing barriers to entry.
To conclude, he talked about opportunities for interventions in humans. The BRAIN Initiative intends to lay a foundation for novel interventions in human brain disorders, and these new technologies are advancing scientific understanding of the circuits and computations underlying complex behaviors. Dr. Ngai predicts that these efforts will lead to the identification of cells and circuits affected in neuropsychiatric disorders and the identification of new therapeutic targets. For example, studies related to treatment-resistant depression, obsessive-compulsive disorder, and deep brain stimulation are currently underway. Dr. Ngai expressed hope that these and similar projects will make great strides in human therapeutics within the next five to ten years.
Dr. Ngai ended his presentation by thanking the many staff and scientists who have contributed to these efforts.
Discussion
Dr. Gordon thanked Dr. Ngai for his presentation and asked if any of the projects are ready to launch or if preliminary technology development is still needed. Dr. Ngai replied that they will use their time until the 2023 funding boost to continue planning, developing, and obtaining pilot data. He anticipated that launch by 2023 will be possible given the rapid pace of technological advancement. In particular, the connectivity project will require ongoing workshops and brainstorming before launch, while the armamentarium project is underway, and the Cell Census project is ready to roll out.
Concept Clearances — Part 2
Identification of Positive Valence System Targets for Novel Suicide Prevention Approaches
Sarah H. Lisanby, M.D., Division of Translational Research
Dr. Lisanby presented a new concept on the identification of positive valence system (PVS)-related targets for novel approaches to prevent suicide. The Research Domains Criteria (RDoC) framework aims to provide a rigorous method for parsing individual heterogeneity across levels of analysis, from genes to circuits to behavior. Examining how RDoC domains of function are related to suicide may facilitate development of precision psychiatric approaches to prevent suicide, a challenging objective given the multiple subtypes and individual pathways that lead to suicide. Currently, the PVS (which includes constructs for reward responsivity, reward learning, and reward valuation) represents a relative gap in the RDoC framework. This concept seeks to encourage studies that test the relationship between the PVS and suicidal thoughts and behaviors. Ideal study designs would link neurocircuitry to behavioral and clinical outcomes and would identify modifiable targets to inform the selection of treatments for the development of PVS-targeted novel interventions. Suicide prevention remains a top priority at NIMH, and new funding opportunities like these will encourage important efforts in this area.
Discussion
Dr. King expressed strong support for this innovative concept and agreed that PVS is a gap in the RDoC framework. She said this concept has the potential to develop novel intervention targets for both behavioral and neurobiological interventions, and to tailor these treatments to the individual and improve effects among targeted groups.
Dr. Ian Henderson had previously expressed support for the concept but was unable to comment at the time due to a power outage.
Dr. Noronha called for a motion to approve the concept. A motion to approve passed.
Systems-Level Interventions for Detecting and Preventing Suicide and Suicidal Behavior in At-Risk Youth
Denise Juliano-Bult, M.S.W., Division of Services and Intervention Research
Ms. Denise Juliano-Bult reviewed an initiative to support research targeting at-risk, underserved youth and developing and testing strategies to improve suicide prevention. This concept aligns with the goals outlined in the National Strategy for Suicide Prevention that aim to reduce the suicide rate in the U.S. by 20 percent by 2025. She explained that suicide is the second leading cause of death for youth aged 10-24 years, and some special populations in this age group (specifically, racial/ethnic minorities) are at even higher risk. Effective, sustainable suicide prevention approaches should account for context and culture and target settings where efforts can reach large numbers of at-risk youth. This concept includes coordination and collaboration within or across youth service providers, programs, and systems; efforts will include risk identification, evaluation, and rapid engagement for at-risk youth. Ideal research will establish feasibility, effectiveness, and rapid uptake of programs to promote suicide prevention.
Discussion
Dr. King suggested that this concept parallels the Zero Suicide Initiative , put forth by the National Action Alliance for Suicide Prevention (NAASP) to provide coordinated risk identification and intervention. She appreciated that the concept expands beyond health systems to target special populations with unmet service needs in other settings, such as juvenile justice and child welfare. She noted that the concept is fairly broad and suggested establishing more specific research priorities and expectations.
Dr. Joseph Telfair agreed that the concept needs more specificity. He also noted that the target population should include homeless and poor youth. He recommended adding an outreach component, which may be facilitated through an established group like the YMCA. Last, he suggested that the concept should allow for intermittent change and consistent identification, so he would expand the last goal to include “challenge and resolve” issues related to services and institutions involved with at-risk populations. Other important factors may include integrating comorbidities, such as opioid use.
Dr. Anita Everett wondered about the opportunity to include retention within measures of quality of care. She also recommended more clearly defined outreach data to determine the trajectory of “caring contacts” rather than limiting the project to office-based care.
Dr. Noronha called for a motion to approve the concept. A motion to approve passed.
PROMOTID: PRomoting Outstanding MentOring: Training, Inclusion, and Diversity
Jay Churchill, Ph.D., NIMH Training Team
Dr. Jay Churchill introduced PRomoting Outstanding MentOring: Training, Inclusion, and Diversity (PROMOTID), jointly developed by the NIMH Training Team and the NIMH Office for Disparities Research and Workforce Diversity. While the importance of diversity has received increasing attention in recent years, much work still remains to be done. One potential area for improvement is the development of a training pipeline to offer upstream opportunities for additional efforts focused on enriching the diversity of the biomedical workforce. Mentors play a key role in this process, and this initiative aims to recognize investigators with an exemplary record of inclusive mentoring and continued commitment to these activities. Investigators with research support from NIMH will be eligible for this award. Dr. Churchill expressed hope that an NIH award to formally recognize inclusive mentoring excellence will elevate and motivate mentoring.
Discussion
Dr. David Henderson asked what type of NIMH support would make one eligible for this award and how the mentorship will be evaluated. He pointed out that other factors across race and ethnicity also require attention. He suggested they consider developing specific guidelines to discourage opportunistic individuals from seeking the award without deeply committing themselves to the cause.
Dr. Joseph Telfair pointed out the need to inform individuals that this opportunity exists. Additionally, other contextual considerations need more clarity, including roles and definitions of mentor and mentee. He recommended considering eligibility exceptions, given that the targeted individuals may be less likely to have the types of NIMH support required for the award.
Dr. Niv expressed concern that increased mentoring activities may come at the expense of other opportunities, including R01s or PI status on large grants. This is particularly troubling, given that researchers of color disproportionately carry the burden of mentoring. She wondered what activities will be funded in pursuit of the workforce pipeline and suggested supporting an activity to develop high-quality mentorship training materials and best practices, which otherwise may be difficult to find.
Dr. Risch expressed mixed feelings about the concept because it implies a need to incentivize mentoring minority scientists, which should be expected and not specifically rewarded. Dr. Gordon answered that there have been mixed responses to the concept. He added that although minority mentorship should be “ground zero,” there are still gaps in the diversity of the workforce pipeline. Dr. Risch indicated that the messaging of this initiative implies that minority mentorship is a burden that must be incentivized.
Dr. Vinogradov highlighted the need to recognize the burden experienced by BIPOC (Black, Indigenous, and people of color) mentors and investigators, who are more often sought for complex mentorship roles than white investigators. She noted that minority investigators might need additional support to manage the cognitively and socially taxing nature of being a minority in a white-dominated culture. Dr. Risch agreed.
Dr. Telfair pointed out that the award may provide a level of appreciation and symbolic support that would provide beneficiaries with a level of clout that would free them up to conduct important work.
Dr. Baldwin said that, from the perspective of university promotion and tenure committee, this might provide committees with more objective, concrete evidence of high-quality mentorship. They heavily weigh mentoring in the decision to promote, but there is little concrete evidence present in the materials they receive during the decision-making process.
Dr. Gotlib agreed that this is a tangible opportunity to recognize the people who are committed to making changes towards diversity and inclusion.
Dr. Niv opposed the idea that mentoring should not be incentivized. She emphasized that training and mentorship take time, effort, and energy. Incentivization acknowledges that these efforts are work on par with research output and publication.
Dr. Blakely added that he interpreted the initiative as a funding mechanism to recognize the broader impact of mentorship on campuses, local universities, programs, and education. He expressed confusion about who will receive the award—the individual or the program that the individual runs. Dr. Churchill answered that it could work both at the individual and the institutional levels. Dr. Blakely recommended clarifying this in the concept. Dr. Risch recommended that the initiative should support programs rather than individuals.
Dr. Noronha called for a motion to approve the concept. One abstained. A motion to approve passed.
Prevention of Perinatal Depression: Identifying who is at Increased Risk and Determining Ways to Improve Intervention Delivery
Eve Reider, Ph.D., Division of Services and Intervention Research
Dr. Eve Reider presented a concept to encourage research addressing major gaps identified in the 2019 U.S. Preventive Services Task Force (USPSTF) recommendation statement concerning use of CBT during the postpartum period. These interventions include strategies for identifying high-risk women, developing and testing tools for selecting women who are most likely to benefit, and implementing service-ready preventive interventions. Their ultimate goal is to contribute to an evidence base of service-ready, scalable, effective perinatal depression prevention interventions that can be sustainably implemented in health care and community settings.
Discussion
Dr. Kamilah Jackson suggested that other factors, such as cost of the models and interventions, would be helpful for policymakers, funders, and legislators. Cost analysis, with consideration for insurance status of the individuals served, may improve traction for implementation and uptake.
Dr. King pointed out that the rationale focuses narrowly on the need for trials to understand how existing interventions can be implemented effectively, sustainably, with fidelity, and at scale. Yet, the goal of the written concept clearance is much broader and includes identification of at-risk women. She wondered if there are clear research questions related to identification, and asked if this interacts with heterogeneity of effectiveness of identification among different subgroups. She also suggested highlighting underserved populations among the priority research areas.
Dr. Noronha called for a motion to approve the concept. A motion to approve passed.
Refinement and Testing of Service-Ready Interventions for Attention-deficit/Hyperactivity Disorder
Mary Rooney, Ph.D., Division of Services and Intervention Research
Dr. Mary Rooney explained that the goal of this concept is to solicit pilot effectiveness projects that apply a mechanisms-based approach to the development and evaluation of interventions for preschoolers with attention-deficit/hyperactivity disorder (ADHD). A growing body of ADHD literature indicates that ADHD onset typically occurs during the preschool years and is impairing and associated with elevated family stress, parent mental health problems, and expulsion from school settings. As a result, there is a need to systematically adapt evidence-based behavioral interventions to meet the needs of preschoolers with ADHD. This initiative will solicit deployment-focused intervention development projects for preschoolers with ADHD with a focus on strategies to tailor interventions, monitor or prevent the emergence of additional ADHD symptoms, target and mediate adverse ADHD trajectories, and incorporate pharmacotherapy as a second-line treatment combined with behavioral intervention.
Discussion
Dr. Everett pointed out that an important component of practical care is the pressure among parents and providers to skip behavioral interventions in favor of medications. She was pleased that the concept emphasizes pharmacotherapy as a second-line treatment. From a services implementation perspective, she recommended focusing on effectiveness in real settings. She also suggested explicitly noting that interventions should occur in multiple settings, not just the preschool environment. Last, she noted that “service-ready” might not be the right term and recommended using “readily implementable” or “easily applied.”
Dr. Jaycox also questioned the term “service-ready.” She said that the mechanism-based approach might contradict applied studies, as mechanisms are more difficult to measure in preschool or home settings than in the lab. A mechanism focus may limit deployment in real-world settings, and the concept may be better served by a different RFA. Dr. Everett added that the possibility of comparative effectiveness might be an adequate approach to position broader uptake.
Mr. Staglin hoped to see strengths-based interventions that recognize that each child may have strengths that are concomitant with ADHD and may be weakened if ADHD is treated too aggressively. This may require individualized work to help each child develop their strengths and pursue success.
Dr. Noronha called for a motion to approve the concept. A motion to approve passed.
NIMH Support for Clinical Trials Research (Reissue)
Mi Hillefors, M.D., Ph.D., Division of Translational Research
Dr. Mi Hillefors presented the reissue of the series of NIMH Clinical Trials funding opportunity announcements (FOAs). These FOAs emphasize an experimental therapeutics approach in pursuit of treatment and prevention of mental illnesses across the lifespan. The concept spans the clinical trial pipeline, from first-in-human trials, early testing of new interventions, confirmatory efficacy trials, and effectiveness trials. Proposed studies must demonstrate an experimental therapeutics approach to examine the mechanisms underlying a disorder or an intervention response, requiring identification of a target or mediator of the intervention and clearly defined go/no-go criteria.
Discussion
Dr. David Henderson asked how NIMH evaluates the impact of the shift of clinical trials focus and wondered what discoveries may have been lost when NIMH shifted their focus to mechanisms. Dr. Hillefors answered that they are considering the impact of this change, but five years post-shift may be too early to fully understand the implications. From the perspective of application success, the success rate is on par with the overall NIH success rate. The next reissue represents an opportunity to closely examine impact.
Dr. Vinogradov added that although the change to an experimental therapeutics approach remained unpopular for several years, most investigators and reviewers by now have accepted the value of the approach. She agreed about the need to examine the outcomes of this shift.
Dr. Noronha called for a motion to approve the concept. A motion to approve passed.
Innovative Mental Health Services Research Not Involving Clinical Trials (Reissue)
Susan Azrin, Ph.D., Division of Services and Intervention Research
Dr. Susan Azrin presented the reissue of PAR-17-264 , “Innovative Mental Health Service Research Not Involving Clinical Trials (R01)”, which has resulted in the funding of mental health services grants in high-priority research areas aligned with Research Goal 4 of the NIMH Strategic Plan for Research (Strengthen the Public Health Impact of NIMH-Supported Research). Priority research areas include but are not limited to suicide prevention, increased access to evidence-based mental health care, optimizing treatment for serious mental illness (SMI), rigorous quality improvement research, optimizing service delivery for people with autism spectrum disorder, and advancing innovative mental health services research methods. The reissue emphasizes projects that will obtain relevant, practical, actionable findings. To this end, researchers will be encouraged to include stakeholder involvement, practice-based research, and full representation of target populations.
Discussion
Dr. Kilbourne expressed her support and said the concept complements others focused on clinical trials by systematically identifying the barriers and facilitators to mental health treatment among diverse populations. She suggested looking at the recent National Academy of Medicine Future of Health Services Research Report , which highlights important research areas that may be of interest to NIMH. These include social determinants of health, community-based participatory research, complex systems engineering, and other artificial intelligence (AI) methods.
Mr. Staglin appreciated the intent of this concept and suggested dissemination to universities and public and private stakeholders such as health care systems. In terms of access to care, he recommended focusing on the fact that two-thirds of referrals to specialized care for SMI never follow up. Improved follow-up and care-seeking behaviors will require efforts to foster trust and reduce stigma in the mental health care system.
Dr. Telfair added that access in general includes access to programs—not just access to care—at the community and hard-to reach (e.g., rural, inner city) population level.
Dr. Noronha called for a motion to approve the concept. A motion to approve passed.
BRAIN Initiative Cell Census Network (BICCN) - Phase III (abbreviated)
Yong Yao, Ph.D., Office of Technology Development and Coordination
Dr. Rausch presented a second concept to continue support for the CNS HIV Antiretroviral Therapy Effects Research (CHARTER), a research cohort focused on the effect of HIV on the central nervous system (CNS). The CHARTER cohort was established in 2002 and is one of few long-term cohorts that has followed patients with HIV CNS disease. This concept would continue to expand the understanding of the mechanisms and genetic factors related to CNS complications in HIV, and to facilitate the development of novel, preclinical strategies.
Discussion
Dr. Blakely expressed excitement that the concept is moving from mouse models to human systems.
Dr. Noronha called for a motion to approve the concept. A motion to approve was passed.
Adjournment
Dr. Noronha said that public commenters can email their written comments to karen.gavin-evans@nih.gov, and these will be shared with Council members.
Dr. Gordon expressed appreciation for the Council’s participation. The open session of the NAMHC meeting adjourned at 1:19 p.m.
Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Mental Health Council
Summary of 261st Meeting, September 15, 2020
Others present:
- Debra Gilliam, Transcriber
- Marie Rowland, Science Writer
Staff Present Virtually:
|
Lisa Alberts |
Bruce Cuthbert |
Sarah Lisanby |
Department of Health and Human Services
National Institutes of Health
National Institutes of Health
National Advisory Mental Health Council
(Terms end 9/30 of designated year)
- Joshua A. Gordon, M.D., Ph.D.
Director
National Institute of Mental Health
Bethesda, MD
Executive Secretary
- Jean Noronha, Ph.D.
Director
Division of Extramural Activities
National Institute of Mental Health
Bethesda, MD
Members
- Laura A. Almasy, Ph.D. (22)
Professor
Department of Genetics
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA - Marjorie L. Baldwin, Ph.D. (22)
Professor
Department of Economics
W. P. Carey School of Business
Arizona State University
Tempe, AZ - Randy D. Blakely, Ph.D. (20)
Executive Director
Florida Atlantic University Brain Institute
Professor of Biomedical Science
Charles E. Schmidt College of Medicine
Florida Atlantic University
Jupiter, FL - David Goldstein, Ph.D. (23)
Director
Institute for Genetic Medicine
Columbia University
Hammer Building
New York, NY - Ian H. Gotlib, Ph.D. (20)
David Starr Jordan Professor and Chair
Department of Psychology
Stanford University
Stanford, CA - Alan E. Greenberg, M.D., M.P.H. (20)
Professor and Chair
Department of Epidemiology
School of Public Health
George Washington University
Washington, DC - David C. Henderson, M.D. (20)
Professor and Chair of Psychiatry
Assistant Dean, Office of Diversity and Inclusion
Boston University School of Medicine
Psychiatrist-in-Chief
Boston, MA - Kamilah Jackson, M.D. (23)
Medical Director
PerformCare
Robbinsville, NJ - Lisa H. Jaycox, Ph.D. (20)
Senior Behavioral Scientist
Rand Corporation
Arlington, VA - Cheryl A. King, Ph.D. (21)
Professor and Director
Youth and Young Adult Suicide Prevention Program
Department of Psychiatry
University of Michigan
Rachel Upjohn Building
Ann Arbor, MI - Gregory A. Miller, Ph.D. (20)
Distinguished Professor
Department of Psychology
Distinguished Professor
Department of Psychiatry and Biobehavioral Sciences Member
University of California, Los Angeles
Los Angeles, CA - Yael Niv, Ph.D. (21)
Professor
Princeton Neuroscience Institute
Department of Psychology
Princeton University
Princeton, NJ - Neil J. Risch, Ph.D. (21)
Director
Institute of Human Genetics
Lamond Family Foundation Distinguished Professor In Human Genetics
University of California, San Francisco
San Francisco, CA - Elyn R. Saks, J.D., Ph.D. (20)
Orrin B. Evans Professor of Law
Gould School of Law
University of Southern California
Los Angeles, CA - Brandon Staglin, M.S. (21)
President
One Mind Institute
Rutherford, CA - Joseph Telfair, DrPH, MPH, (23)
Professor and Associate Dean for Public Health Practice and Research
Karl E. Peace Distinguished Chair of Public Health
Fellow, Royal Society of Public Health
Jiann-Ping Hsu College of Public Health
Georgia Southern University
Statesboro, GA - Sophia Vinogradov, M.D. (22)
Donald W. Hastings Endowed Chair
University of Minnesota Medical School
Professor and Department Head
Department of Psychiatry
Minneapolis, MN - Hongkui Zeng, Ph.D., (23)
Executive Vice President and Director
Allen Institute for Brain Science
Seattle, WA
Ex Officio Members
Office of the Secretary, DHHS
Xavier Becerra
Secretary
Department of Health and Human Services
Washington, DC
National Institutes of Health
Francis Collins, M.D., Ph.D.
Director
National Institutes of Health
Bethesda, MD
Department of Veterans Affairs
Amy M. Kilbourne, Ph.D., M.P.H..
Director
Quality Enhancement Research Initiative
Health Services Research & Development
Department of Veterans Affairs, Ann Arbor
Ann Arbor, MI
Department of Defense
CAPT Chad Bradford
Program Director for Mental Health Policy
Office of the Secretary of Defense
Health Services Policy and Oversight
Falls Church, VA
Liaison Representative
Anita Everett, M.D., DFAPA
Director
Center for Mental Health Services
US, HHS Substance Abuse and Mental Services Administration
Rockville, MD