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Transforming the understanding
and treatment of mental illnesses.

NAMHC Minutes of the 259th Meeting

May 19, 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 259th meeting at 9:00 am, May, 2020 via the videocast virtual platform, Zoom. In accordance with Public Law 92-463, the session was open to the public until approximately 1:30 pm, and closed thereafter from 2:00 pm 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 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 first virtual videocast NAMHC meeting by expressing gratitude for the members and the work that the National Institutes of Health (NIH) is doing during these challenging times, and he welcomed Current Council members and the public. Dr. Gordon welcomed the four new Council members: David Goldstein, Ph.D., Kamilah Jackson, Ph.D., Joseph Telfair, Ph.D., and Hongkui Zeng, Ph.D., and one new Ex-Officio member CAPT Chad Bradford, representing the Department of Defense (DoD). Following introductions, the Council unanimously passed a motion approving the final Summary Minutes of the February 5, 2020 meeting.

NIMH Director’s Report

Joshua Gordon, M.D., Ph.D.

Legislative Updates

Dr. Gordon provided an update of recent NIH/NIMH congressional activities. Prior to the COVID-19 pandemic, the NIH held a Congressional Networking Reception to celebrate the work of The Children’s Inn at NIH, which accommodates families of children staying at the Clinical Center to receive dire treatment and participate in research. Courtesy visits were conducted with Congressmen Representatives Jerry McNerney (D-CA) and Rep. Eliot Engle (D-NY).

Dr. Gordon contributed to a roundtable discussion with the Congressional Mental Health Caucus, in which members of the Caucus discussed research in suicide prevention, autism, children’s mental health, and psychosis, as well as advances in digital approaches to mental health. Dr. Gordon emphasized the amount of interest garnered specifically towards autism research and the bipartisan interest that was expressed towards mental health in general. He also met with Representative Bonnie Watson Coleman (D-NJ) and members of the Congressional Black Caucus (CBC) Emergency Taskforce on Black Youth Suicide and Mental Health and Working Group to review the Taskforce report, “Ring the Alarm: The Crisis of Black Youth Suicide in America” to glean a better understanding of the increasing rate of suicide in Black youth in the United States.

Dr. Francis Collins, Director of NIH, testified before the House Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies. There were many questions regarding the COVID-19 pandemic, but also inquiries concerning other sections of the NIH budget. Additionally, Dr. Collins and Dr. Gary Disbrow (of the Office of the Assistant Secretary for Preparedness and Response) provided testimony before the Senate Health, Education, Labor and Pensions (HELP) Committee. Dr. Collins presented updates on the NIH’s response to COVID-19, including testing.

Appropriations and NIH/NIMH Budget

Congress has approved multiple Emergency Supplemental Appropriations: the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Congress also passed the Paycheck Protection Program (PPP) and Healthcare Enhancement Act, which provides funding to multiple NIH Institutes, Centers, and Offices, as well as the NIH Office of the Director, to address support needed during the pandemic. The FY 2020 NIMH Budget is estimated to be nearly $2 billion, which may allow NIMH to match last year’s success rate of about 25 percent, with an increasing number of applications and ultimately, awarded applications.

Responding to COVID-19

NIH is heavily engaged in promoting information about COVID-19, providing online resources for both the scientific community and the general public, as well as updates for NIH grantees to continue their research during the pandemic.

NIMH issued a Notice of Special Interest (NOSI) to highlight interest in research intended to strengthen the mental health response to COVID-19 and public health emergencies (NOT-MH-20-047). NIMH also signed onto two related NOSIs with mental health components, one published by the National Institute on Minority Health and Health Disparities (NIMHD), and the second from the National Institute on Aging (NIA). These notices build upon what is already known about mental health during pandemics and other disasters, and focus specifically on the development of interventions in the context of a public health emergency.

NIH has conducted research in response to the pandemic, including a clinical trial of hydroxychloroquine and azithromycin combinations. Hydroxychloroquine has been found ineffective on its own, and the Food and Drug Administration (FDA) has responded with a warning that it only be used in hospital settings. The NIH also supported research surveys of the impact of COVID-19 on the rare diseases research community and on research related to first responders.

In the short term, NIMH is providing supplements to existing grants in support of research on interventions and the increased demand for mental health services during the pandemic. Dr. Gordon has published multiple Director’s Messages on coping with COVID-19 on the NIMH website. In addition, he and former Representative Patrick Kennedy are co-chairing the National Response Steering Committee, an initiative sponsored by the National Actional Alliance for Suicide Prevention (NAASP) that aims to provide a coordinated mental health and suicide prevention response during the pandemic.

Dr. Gordon acknowledged the NIMH staff for their hard work towards the COVID-19 response.

NIMH News to Know

At the February NAMHC meeting, Council members requested more information on the context of the recent NIMH Principal Investigator Diversity Analysis report which compared demographic data for NIMH application counts and funding rates between 2008 and 2018 and showed disparities by gender and race at NIMH and NIH-wide levels. Dr. Gordon presented a follow-up that highlighted these differences across NIMH divisions. Although there is no significant difference in success rates in gender across NIMH, there is a slight statistically significant difference in gender specifically in the success rates for the Division of Neuroscience and Basic Behavioral Science (DNBBS). This disparity is reflected in the percentage of applications across divisions. In the Division of AIDS Research (DAR) and the Division of Services and Intervention Research (DSIR), there is no gender disparity in applications. In the Division of Translation Research (DTR), males represent 60 percent of applications and females represent 40 percent. In DNBBS, the gender disparity is greater, with males representing 73 percent of the applications and females representing only 27 percent. However, looking at application data across ten years, there does appear to be some equalizing in these gender disparities.

Dr. Gordon also noted that success rates are also related to budget changes. Across divisions that fund mental health research, there is an overall increase of success rates that is related to budget increases. Decreased rates of funding were seen in DAR, which is due to the budget for AIDS research remaining stable while inflation has increased over time.

Dr. Gordon described the differences in success rates by race and ethnicity, with Black and Hispanic applicants (and Asian applicants to a lesser extent) having lower success rates than White applicants. Although there are differences in success rates in race and ethnicity across certain divisions, these differences cannot be fully explained by topic area. These disparities may appear to be decreasing over time, but there is too much variance across the years to conclude if there has been improvement.

Dr. Gordon addressed Council members’ interest about the characteristics of the applicant pool, with the possibility of differences in success rates depending on the institution from which applicants apply. One way to address this question was to consider differences in success rates related to research conducted in states that are in the Institutional Development Award (IDeA) Program. The IDeA program broadens the distribution of NIH funding to states that have historically received less NIH funding by helping these states become more competitive. There are discrepancies in research funding between IDeA-supported and non-IDeA-supported states across gender, race, and ethnicity. Several factors may be involved in this variance, including the institution from which researchers are applying, or the topics for which individuals apply. At the NIMH-level, there is not enough data to analyze these factors. Data from across NIH is needed to further comprehend these trends and how to reduce the disparities.

Dr. Gordon provided an update on the reauthorization of the Interagency Autism Coordinating Committee (IACC). The IACC has received several nominations for new committee members. Once the committee has been appointed, the IACC will resume their meetings. In the meantime, the IACC has provided the autism community with resources on the coronavirus, which Dr. Gordon encouraged Council members to view.

In terms of NIMH staff news, Dr. Gordon announced that Dr. Armin Raznahan was awarded tenure by the NIH Central Tenure Committee.

NIH Policies, Progress, and Initiatives

Dr. Gordon provided a brief update on NIH-wide initiatives. The NIH response to the opioid epidemic is a research effort called the Helping to End Addiction Long-termSM Initiative or NIH HEAL InitiativeSM. A meeting of all HEAL investigators was held shortly before the pandemic, and included a large, multidisciplinary group of experts in pain and addiction research, discussing topics from basic research to services and stigma.

Science Highlights

Dr. Gordon concluded his update with a review of science highlights. NIMH encourages multimodal approaches to better understand stress biology and its relevance to depression, as well as genome-wide approaches to study genetic and epigenetic effects. Dr. Gordon presented a study that utilized both approaches—a paper from Dr. Eric Nestler and his team that illustrated the role of long non-coding RNA strands in depression. This study showed that these strands are differentially expressed in several brain regions in individuals with depression. Further, expression differs across males and females —especially in the frontal cortex. Using a genome-wide approach, Dr. Nestler found that one long-coding RNA, LINC00473, was differentially downregulated in females with depression and normally expressed in depressed males. The research team theorized that LINC00473 may be a female-specific driver of stress resilience which is aberrant in females with depression, and an intervention regulates expression of LINC00473 may therefore improve behavioral responses to stress. Dr. Gordon reiterated that this study exemplifies NIMH objectives by utilizing multiple approaches in stress biology and genomics.

Dr. Gordon then highlighted a modeling study that used multi-modal data to stratify individuals towards understanding what predicts responses to medication versus placebo. Predictive modeling to better understand patient response can be challenging, especially when developing an approach for clinical decision-making. This model looked at the relationship between variables in individuals with depression (e.g., age, symptom severity) and the response to medication versus placebo. The research team looked at the response patterns by mapping a single patient variable (an index) with a linker to an outcome variable. This approach of using a single index model with multiple links performed better than previous models to stratify patients and predict responses. The takeaway of this study is that complex relationships can be modeled between multi-modal variables to predict responses using a modeling approach that can be more actionable, generalizable, and require less data than an artificial intelligence approach.

Discussion

Dr. Joseph Telfair inquired about the rollout of a recent Notice of Special Interest, NOT-MH-20-047, specifically where vulnerable populations are of special concern. Dr. Gordon responded that the notice has been out for several weeks and is a supplement to existing grants. These vulnerable populations are being defined as populations with health and mental health disparities, as well as first responders and other essential workers who are at increased risk for COVID-19. The notice is specific to supplements as a fast way to provide funding, and NIH will have a different announcement for new grant funding in the coming weeks.

Dr. Telfair asked if there should be direction for defining essential personnel, particularly personnel that work in high-risk situations but who are not intuitively considered. Dr. Gordon explained the NIMH commitment to include all essential workers, not just first responders and healthcare workers, but also personnel such as grocery clerks or delivery workers. Dr. Telfair added that these populations already experience pre-existing stress, and that the pandemic exacerbates this. Dr. Gordon concurred that people with pre-existing financial, social, and mental health stress are at greater risk and NIMH will consider them as they work to scale up mental health response in the context of a pandemic.

Dr. Neil Risch asked if the race/ethnicity data are broken down by first submission versus revised submission. Dr. Gordon replied that NIMH data were combined, but that it was a great suggestion. Dr. Risch suggested that NIMH consider the amount of improvement between initial and successive submissions, since applicants may improve after receiving feedback.

Mr. Brandon Staglin asked about the goals and progress of the National COVID Response Group and what other organizations were participating. Dr. Gordon explained that the Mental Health & Suicide Prevention National Response to COVID-19 is sponsored by the National Action Alliance for Suicide Prevention, and that several organizations were participating, including organizations such as the Kennedy Forum, federal agencies such as the Substance Abuse and Mental Health Services Administration (SAMHSA), private organizations such as Union Pacific Railroad, large healthcare organizations such as Aetna and Kaiser, and other suicide prevention and advocacy nonprofits. The National Response also provides messaging resources for these different types of organizations, and the best practices they could implement. Former Representative Patrick Kennedy has been a valuable contributor due to his background in mental health advocacy and a public relations campaign has increased awareness of the mental health consequences of the pandemic, including the need for increased access to care.

Dr. Yael Niv commented on the unchanging rate of grant submissions by women and asked why it is still so low and what can be done to increase it. Dr. Gordon responded that across NIMH divisions, NIMH shows a larger portion of women applying than the rest of NIH, but the percentage of women applicants for basic neuroscience is still low. Dr. Niv suggested that the low numbers of female applicants in both basic science and Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative research has been the topic of much discussions, including implicit issues such as how eligibility criteria may have unintended consequences for women. Dr. Gordon wondered if such implicit issues are present across other NIH institutes that include neuroscience. Dr. Niv said it would be interesting to compare NIMH success rates to the National Institute on Drug Abuse (NIDA).

Dr. Laura Almasy inquired about breaking down gender, race, and ethnicity disparities by proposal type. Dr. Gordon responded that there are fewer disparities in the K awards than R01s, but that there were too few grants to determine the significance.

Dr. Telfair asked if the diversity award data has been broken down by focus and history of the review panels. Dr. Gordon said that this has been done at the NIH-wide level, which provided a foundation for thinking that a portion of variance was related to topic area. They found that approximately 20 percent of the variance was due to Black researchers applying more often to study sections with overall lower success rates. Again, there are not sufficient data to investigate this within NIMH specifically.

Dr. Gordon mentioned that Dr. Andrea Beckel-Mitchener, Director of the Office of Workforce Diversity and Health Disparity Research, is involved with the transition team for the BRAIN Initiative and is working with participating Institutes and Centers to resolve issues in gender disparity. In the last few months, the NIH Office of Director has been committed to the pandemic response, which has likely delayed progress of this effort.

Dr. Randy Blakely asked if there had been any impact from efforts to balance disparities in training grants and if these numbers deflect from overall trends shown from several decades of data. Dr. Gordon answered that the answer is probably yes and the training team, who provides a presentation on this every year, can analyze outcomes more in depth. It is not always certain where diversity trainees are, but recent data collection has improved. Dr. Gordon will follow up on these questions at the next Council meeting.

Announcing the Workgroup on Clinical High Risk for Psychosis

Dr. Gordon announced a new Workgroup on Clinical High Risk for Psychosis. Schizophrenia is among the top 15 leading causes for disability globally. Individuals and communities are burdened by its early onset, long-lasting trajectory, and the consequences of untreated symptoms. Even with treatment, full recovery can be challenging for individuals with schizophrenia. However, there has been considerable success in enhancing treatment for those with first episode psychosis, but more work is needed to reduce the burden of schizophrenia and prevent the worst of the disabilities. One approach is the early identification and treatment of subpopulations that are at clinically high risk for psychosis. This population has been studied extensively, which has led to the development in predictors of those who will experience psychosis, as well as those who may not be diagnosed but still experience symptomatology that will require long-term care.

The objective of this Workgroup is to bring together public and private stakeholders to advise the NAMHC on initiatives to develop biomarkers and clinical endpoint measures to accurately predict psychosis and non-psychosis outcomes, enhance treatment development, and develop compounds for innovative medications. The overall goal is to identify subgroups who are likely to benefit from a particular intervention. The charge of the Workgroup will be to review and analyze summary statements from applications regarding the following two initiatives: Clinical High Risk for Psychosis Research Network (RFA-MH-20-340) and Clinical High Risk for Psychosis Data Processing, Analysis, and Coordination Center (RFA-MH-20-341). These initiatives were published and applications are currently under review. The Workgroup will provide input for the selection process for grants, which will provide integral input from individuals with lived experience, advocacy groups, drug companies, and other intervention developers. This will ensure that funded applications will translate to meet the specific needs of those at high risk for psychosis, those who are searching for solutions and better methods towards recovery. In addition to reviewing and analyzing applications, the Workgroup will be expected to provide more extensive advice to the Council while incorporating a wider array of stakeholders.

Discussion

Dr. Jean Noronha and Dr. Gordon asked for volunteers from the Council to participate in the Workgroup. Dr. David Henderson and Dr. Gregory A. Miller volunteered to serve. Dr. Noronha suggested there will be a virtual Workgroup meeting, possibly in early August.

NIMH Strategic Plan for Research

Dr. Gordon announced that the new NIMH Strategic Plan for Research is now public and thanked the Council members and other stakeholders for their contribution to its development. The stakeholder feedback was comprised of individuals with lived experience, family members, care providers, scientists from both academia and industry, advocates, and professional organizations. Dr. Gordon also thanked NIH and NIMH staff; NIMH leadership; the Strategic Objective and Cross-Cutting Research Groups; the Interdepartmental Serious Mental Illness Coordinating Committee; and, the NIMH Office of Science Policy, Planning, and Communications (OSPPC) for their contributions and feedback.

Dr. Gordon reviewed the timeline and process of stakeholder input for the Strategic Plan, providing several examples of how feedback had been integrated. Dr. Gordon also reviewed the feedback gathered from the Request for Information (RFI), for which over 6,000 comments were received. NIMH staff developed a process to address these comments, which categorized feedback into three topics: general, personal experience, and actionable recommendations. Some common themes from the RFI were prevention, stakeholder-informed research design, development across the life span, animal models, environmental influences, and contributions and interactions of multiple factors.

Dr. Meredith Fox, Director of OSPPC, thanked her team for their contributions. She briefly reviewed each section of the Strategic Plan, highlighting the four Goals of the plan, which are: Define the Brain Mechanisms Underlying Complex Behavior, Examine Mental Illness Trajectories Across the Lifespan, Strive for Prevention and Cures, and Strengthen the Public Health Impact of NIMH-Supported Research.

Dr. Fox then reviewed the digital version of the Strategic Plan. A downloadable PDF of the plan is also available online. Dr. Fox provided instructions for navigating the website and emphasized that the digital version of the Strategic Plan is advantageous because it can be updated as new information becomes available.

Dr. Fox then explained the plan for the broad dissemination of the Strategic Plan. In order to reach a wide-ranging audience, NIMH will promote the Strategic Plan via media outreach, NIMH’s Exhibits Program, national conference presentations, the NIMH Education and Awareness portal, and social media. Dr. Fox provided a link to download the materials.

Discussion

Dr. Gordon conveyed his appreciation for the ability to continuously update the digital version of the Strategic Plan in real time, and that he hopes to link it with other strategic plans within other NIH Institutes and Offices. He reviewed comments from Council members, expressing their appreciation for its accessibility and ability to update it. There was an inquiry about embedded links to other NIMH resources, specifically for outreach or educators. Dr. Fox provided the link for the education and awareness page.

Dr. Gordon responded to a question from Mr. Staglin about how NIMH defines “cure” and how realistic the goal is within the timeline of the plan. Dr. Gordon responded that this topic was part of a previous Council discussion and that the word “cure” was met with some controversy, with some striving for a cure and others suggesting that “cure” should not necessarily be a goal. Therefore, NIMH has included “cure” as an aspirational goal that may not be achievable in the next five years but can still provide opportunities and strategic direction. Mr. Staglin agreed that “cure” is an admirable goal but defining it and the different perspectives involved should be considered in the future. Dr. Telfair asked how NIMH will define or assess outcomes of the Strategic Plan, suggesting that operational definitions are integral in analyzing indicators of progress. Dr. Fox replied that outcome measures of the Strategic Plan will be considered in the next phase of plan development.

Dr. Gordon reviewed a comment from the public about the definition of “special interest groups” that responded to the RFI. Dr. Gordon responded that special interest groups also include advocacy groups including individuals with lived experiences, family and community support groups, and issue-oriented groups.

Mr. Staglin inquired about the initiatives to encourage public engagement with the Strategic Plan. Dr. Fox responded that there has been significant preparation including engagement via conferences, sharing through nonprofits such as the National Alliance on Mental Illness and Mental Health America, social media, and webinars. She welcomed suggestions for engaging with different stakeholders.

Concept Clearances

From Genomic Association to Causation: A Convergent Neuroscience Approach 2.0

Linda Brady. Ph.D.

Dr. Brady explained that the objective of this project is to develop an explanatory model of psychopathology, with attention to a mechanistic understanding across disorders and across neurodevelopmental trajectories. Applicants for Convergent Neuroscience 2.0 are encouraged to use unbiased genetic studies, generate predictive multiscale computational models, iteratively self-revise, and harmonize data across consortia. Currently, applications are urgently sought in copy number variance and high-penetrance single gene variant effects, polygenic contributions, and higher-order levels of analysis (such as behavioral domains or clinical measures).

Discussion

Dr. Blakely asked if the project would solicit neuroscience approaches that were not specifically covered, suggesting that, when instructing biomedical researchers, the word “encouraged” is less vague than the word “allow.” This suggestion comes from his own experience in building data-sharing consortia with a top-down approach to genetic data, and he pointed out the need to build a program that can flexibly accommodate unpredicted outcomes.

Dr. Niv suggested that a multidisciplinary, multi-data approach may be too restrictive for genomic hypotheses about psychopathology; rather, NIMH might consider using environmental data to include epigenetic influences. Dr. Niv added that NIMH should take care not to limit a proposed project’s scope to wet (or experimental) lab-based predictions. Dr. Blakely concurred that a project should be inclusive of many domains without attempting to address all of them in a single project. Dr. Brady agreed and said that each project does not require more than one or two levels of analysis.

Dr. Noronha called for a motion to approve the concept. A motion to approve was passed.

BRAIN Initiative: Organizing Resources for Brain Cell Type-Specific Access and Manipulation Across Species

Greg Farber, Ph.D. (on behalf of Douglas Kim, Ph.D.)

Dr. Farber provided the background for this concept, which focuses on the key barriers to developing cell-type access tools—for example, lacking a catalogue of validated cell-type reagents.

The BRAIN Initiative 2.0 Working Group report specifically called for a solution to this issue. To this end, the goal of this concept is to evaluate the existing technologies for cell-type specific access to create pilot production, distribution, and atlas resources.

Discussion

Dr. Hongkui Zeng expressed her support for this concept. As a participant in the BRAIN Initiative Cell Census Network, Dr. Zeng explained that this project is a rich resource for understanding the underpinnings of different cell types and the regulatory mechanisms that drive cellular processes. She noted the importance of using this knowledge to generate tools that enable researchers to examine the structure, connectivity, and function of these cells. Dr. Zeng concluded that this concept provides a mechanism for scientists to organize, coordinate, cross-validate, and share technologies to make tools available to the community.

Dr. Blakley added that, from a practical standpoint, the title and content of the document were inconsistent, conveying a management-adjacent structure rather than an experimental structure. He encouraged NIMH to provide clearer guidance on using bioinformatics from rich datasets that have already been generated and include educational resources about these datasets. Dr. Farber said that they will consider adding educational resources.

Dr. Noronha called for a motion to approve the concept. A motion to approve was passed.

BRAIN Initiative: Next Generation Technologies for Brain Microconnectivity Analysis

Greg Farber, Ph.D.

Dr. Farber reviewed the second concept from the BRAIN Initiative, which focuses on next-generation technologies to study brain microconnectivity. Given that the BRAIN 2025 Report calls for a complete and accurate mapping of neural circuit structure in human and animal brains, this concept aims to address the urgent need for faster, more cost-effective, scalable microconnectomic technologies. The concept will cover a diverse array of microconnectivity-related topics, such as use of living versus post-mortem brain tissue or the pipeline of tissue preparation. Dr. Farber concluded by highlighting the role for interagency collaboration on this project, particularly with the Department of Energy (DOE).

Discussion

Dr. Niv asked for clarification about a DOE collaboration. Dr. Farber replied that these technologies, if successful, will require multi-site facilities support (including laboratories and computational facilities)—an infrastructure that the DOE can readily provide.

Dr. Zeng asked if this initiative covers both primate and whole-mouse brain connectomes, which Dr. Farber confirmed. She also asked for a general timeline towards mapping a whole-human brain connectome, and Dr. Farber said he anticipates a two-phase, multi-year approach. Dr. Zeng suggested that a rigorously demonstrated proof of principle from investigators will be key for the initiative, given the major investment necessary to support the project. Dr. Farber agreed.

Dr. Noronha called for a motion to approve the concept. A motion to approve was passed.

Mood and Psychosis Symptoms During the Menopause Transition

Sarah Hollingsworth Lisanby, M.D.

Dr. Lisanby explained that researchers still do not understand why the menopausal transition period is associated with new onset or worsening of preexisting mood and psychotic disorders. The goal of this concept is to advance translational research to understanding the mechanisms underlying this phenomenon and to identify targets for future treatment development. Potential research areas include risk factors to identify women who are at high risk for experiencing these symptoms, mechanisms underlying new onset of symptoms, the role of reproductive steroid levels, and biomarkers for mood and psychosis symptoms.

Discussion

Dr. Henderson agreed that this is an important topic to address. Dr. Sophia Vinogradov commented that the project may benefit from efforts to gain insight about the early developmental trajectory of high-risk women. She also pointed out that this concept could contribute to knowledge about later risk for dementia.

Dr. Noronha called for a motion to approve the concept. A motion to approve was passed.

Digital Healthcare Interventions to Address the Secondary Health Effects of COVID-19 for Health Disparity and Vulnerable Populations

Susan Borja, Ph.D.

Dr. Borja introduced these concepts as the product of a trans-NIH Working Group to respond to the social, behavioral, and economic health impacts of COVID-19. Among other health impacts, Dr. Borja pointed out regional disparities in the ability to comply with state-mandated COVID-19 orders, loss of insurance due to economic decline, and widespread emotional distress as a result of the pandemic. The Working Group aims to address these health disparities, which disproportionately impact racial and ethnic minorities, as well as economically disadvantaged, rural, and sexual/gender minorities. Other vulnerable populations include those housed in chronic care facilities, incarcerated, or experiencing homelessness.

The goal of this concept is to assess the effectiveness and sustainability of a digital health intervention that addresses the secondary health effects of COVID-19. One of the primary objectives of the concept is to address the “digital divide,” which stratifies vulnerable populations by digital literacy or access. Investigators are also expected to test the effectiveness of digital platforms to bridge interventions, such as linking behavioral health care with other medical care. Through this initiative, the Working Group also aims to promote partnerships between academics, digital health technology developers, delivery platforms, end users, and other stakeholders.

Discussion

Dr. Telfair applauded the concept for its broad scope, but he cautioned that the targeted vulnerable groups historically underutilize critical acute care and mental health services, and this trend will likely continue with digital health technologies. He stated that researches should be encouraged to focus their efforts more narrowly on the development and testing of real-time adaptive customized interventions, enabling NIMH to learn more about digital healthcare interventions among target populations with low healthcare utilization.

Dr. Vinogradov commended the concept for including screening and assessment tools among potential research directions. She also pointed out that researchers should consider the unknown and unintended consequences of long-term social isolation, noting that technology-based approaches may exacerbate these effects.

Dr. Noronha suggested that both of Dr. Borja’s concepts be voted on together.

Community Interventions to Address the Consequence of the COVID-19 Pandemic for Health Disparity and Vulnerable Populations

Susan Borja, Ph.D.

Dr. Borja presented a second concept produced by the trans-NIH Working Group, which is a complementary effort to the preceding concept. Dr. Borja explained that this second concept aims to invite researchers to evaluate the role and impact of community interventions, both to impact mitigation strategies to prevent virus transmission and to examine newly implemented interventions for pandemic-related adverse health consequences.

The concept will include naturalistic experiments and prospective interventions to prevent or slow the transmission of COVID-19, including evaluation of local and state policies and programs intended to mitigate exposure and reduce negative impact of the virus. The concept will address a broad array of secondary health effects, including food insecurity, home environmental exposures, poor sleep, social isolation, and sedentary lifestyle. Much like the preceding concept, this concept will also develop partnerships; in this case, they will collaborate with community-based organizations and other public health stakeholders.

Discussion

Dr. Lisa Jaycox suggested drawing on the existing evidence base of techniques for supporting communities during crisis.

Dr. Telfair applauded the concept in general; however, he disapproved of such a broad approach to community interventions. He suggested it is too complex a topic to comprehensively account for a multitude of community-related factors, including personal and collective influences of subgroups, messaging, cognitive dissonance, and other issues. Dr. Telfair also suggested that the concept overview should have included more operational detail, including specific definitions of “implementation,” a scan of existing programs, and policies that support these community interventions.

Dr. Noronha called for a motion to approve both concepts. The concepts were approved with two Council members voting in opposition to the second concept.

Centers for Practice-Based Effectiveness and Services Research with Near-Term Impact

Joel Sherrill, Ph.D.

Dr. Sherill explained that the goal of this concept is to support high-impact research with near-term potential to advance clinical practices and advance knowledge in mental health. Specifically, NIMH aims to renew and extend the Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Centers, which address major mental health problems observed across the lifespan, and function as catalysts for innovative research aimed designing, delivering, and improving interventions and services. Each ALACRITY Center incorporates features to speed the translation of research into practice, including infrastructure that leverages clinical practice and provides experimental laboratory facilities. The Centers also broaden traditional clinical and mental health services collaborations by partnering with stakeholders and experts in behavioral economics, data science and informatics, and health systems engineering.

NIMH currently supports eight ALACRITY Centers. Going forward, NIMH encourages research to identify new opportunities for high-priority translational research in areas of unmet need, such as suicide prevention.

Discussion

Dr. Cheryl King asked about lessons learned from the ALACRITY Center Program. Dr. Sherrill said that NIMH has learned valuable information about organizing and maximizing yields from cross-disciplinary teams and how to orient the ALACRITY Centers towards national dissemination of resources.

Mr. Staglin asked if the ALACRITY Centers Program has considered networking to collectively analyze outcomes for use in new applications, models, and quality improvement projects. Dr. Sherrill replied that the Center investigators use a set of common measures and hold regular meetings to discuss standardized assessment approaches and collaborative analyses.

Dr. Noronha called for a motion to approve the concept. A motion to approve was passed.

Service-Ready Tools for Identification, Prevention, and Treatment of Suicide Risk

Joel Sherrill, Ph.D.

Dr. Sherill reviewed a second initiative, which was developed in recognition that broader and better implementation of evidence-based strategies can improve the quality and outcomes of suicide prevention services. Because evidence-based practices are not widely or uniformly implemented, there is a pressing need for scalable, practice-ready versions of research-supported approaches to facilitate uptake, effective delivery, and sustained use of these evidence-based practices for reducing suicide risk.

NIMH’s goal is to support research on tools and strategies to reduce the United States suicide rate by 20 percent in the next five years. Applicants for this concept are expected to employ best practice research strategies to develop tools that can be integrated into practice with minimal reconfiguration by the end user. The concept also requires a deployment-focused approach with attention to stakeholder perspectives and clinical workflows.

Discussion

Dr. Jaycox noted that translating evidence-based approaches into practice will be particularly challenging during the ongoing pandemic crisis. Dr. King agreed that many existing treatments are effective for suicide prevention, but scalability and sustainability remain a significant consideration. Dr. Jaycox and Dr. King agreed that suicide rate reduction is a high-priority research area.

Dr. Noronha called for a motion to approve the concept. A motion to approve was passed.

Mental Health Research Awards for Innovative New Scientists in Low- and Middle-Income Countries

Dianne Rausch, Ph.D.

Dr. Rausch presented on behalf of the Center for Global Mental Health Research. The goal of this initiative is to overcome common barriers and limitations among young independent researchers as they seek to launch successful careers.

This concept aims to emphasize individual career development, rather than research capacity building, for Low- and Middle-Income Countries (LMIC) investigators who are developing their first R01. Their specific goal is to increase the number of LMIC investigators who pursue and lead high-impact, innovative research projects that transform understanding of the etiology, pathophysiology, and trajectory of mental health disorders.

Discussion

Dr. Henderson suggested that NIMH can increase its role in this initiative by holding weekly webinars to distribute important mentorship resources. Dr. Rausch said they will take this into consideration. Dr. Telfair commented that a mentoring supplement would be critical for the success of this project.  

Dr. King agreed and pointed out the importance of facilitating a successful trajectory among talented, underrepresented early-career investigators. She also noted that this effort will catalyze more globalized research and learning initiatives.

Dr. Becky Wagenaar-Miller (on behalf of Dr. Noronha) called for a motion to approve the concept. A motion to approve was passed.

Renewing the CNS HIV Antiretroviral Therapy Effects Research (CHARTER) to a Research Resource

Dianne Rausch, Ph.D.

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. Alan Greenberg asked about recent productivity and utilization of the CHARTER data over the past five years and the cost-benefit of using it. Dr. Rausch said that there have been hundreds, and possibly thousands, of requests for tissue, and that there is a careful process for evaluating requests because it is such a valuable resource. The most recent data have not yet been published on the website because of administrative and data ownership issues. The estimated cost of maintaining the cohort is about $800,000. NIMH believes that this cohort should be a collaborative effort across multiple NIH institutes.

Dr. Blakely agreed with Dr. Greenberg’s comments and is in favor of maintaining this initiative.

Dr. Wagenaar-Miller (on behalf of Dr. Noronha) called for a motion to approve the concept. A motion to approve was passed.

Abbreviated Concept Clearances

Discovery of Probes for Novel Brain Targets

Cellular and Molecular Biology of Complex Brain Disorders

Data Archives for BRAIN Initiative

Dr. Noronha briefly reviewed the three abbreviated Concept Clearances.

Dr. Wagenaar-Miller (on behalf of Dr. Noronha) called for a motion to approve the abbreviated concepts. A motion to approve was passed.

Public Comment Period

Public comments can be emailed to rwagenaa@mail.nih.gov

Adjournment

Dr. Gordon invited Council members to submit any additional comments or questions regarding the Concept Clearances. The open session of the NAMHC meeting adjourned at 1:26 pm.

Closed Session

The grant application review portion of the meeting was closed to the public in accordance with provisions as set forth in Section 552b(c)(4) and 552b(c)6. Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended. The closed session was set to resume at 2:00 pm.

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Mental Health Council
Summary of 259th Meeting, May 19, 2020

Others present:

  • Debra Gilliam, Transcriber
  • Marie Rowland, Science Writer

Staff Present:

Lisa Alberts
Ruben Alvarez
Ishmael Amarreh
Paige Anderson
Lizzy Ankudowich
Lisa Applewhite
Victoria Arango
Alexander Arguello
Frank Avenilla
Susan Azrin
Crystal Barksdale
Anita Bechtholt
Rebecca Beer
Yvonne Bennett
Yancy Bodenstein
Jasenka Borzan
Beth Bowers
Linda Brady
Pim Brouwers
Jenny Browning
Sandra Buckingham
Bettina Buhring
Holly Campbell-Rosen
Monica Carter
Oni Celestin
Mindy Chai
Sharon Chang
Vin Charles
Zieta Charles
Mark Chavez
Jay Churchill
Claire Cole
Lisa Colpe
Nichole Cook
Heather Coulter
Bruce Cuthbert
Debra Dabney
Mannan Dasti
Alexander Denker
Jamie Driscoll
Tara Dutka
Jaime Anne Earnest
Jovier Evans
Syreeta Evans
Gregory Farber
Michael Freed
Stacia Friedman-Hill
Nick Gaiano
Rebecca Garcia
Marjorie Garvey
Karen Gavin-Evans
Rachel Goldman
Meg Grabb

Gregory Greenwood
Adam Haim
Ileana Hancu
Wanda Harris-Lewis
Samantha Helfert
Robert Heinssen
Mi Hillefors
Meena Hiremath
Andrew Hooper
Andrea Horvath Marques
Cathleen Hsu
Shuang-Bao Hu
Ann Huston
Kelli Ingram
Eliza Jacobs-Brichford
Katelyn Janicz
Terri Jarosik
Carole Jelsema
Kendall Johnson
Andrew Jones
Jeymohan Joseph
Denise Juliano-Bult
Setareh Kamali
Eugene Kane
Alice Kau
Ashley Kennedy
Douglas Kim
Megan Kinnane
Susan Koester
David Leitman
Kelly Linthicum
Sarah Lisanby
Allen Lo
Annette Marrero Oliveras
Rebecca Martin
Julie Mason
Douglas Meinecke
Anna Mikulak
Dawn Morales
Diana Morales
Sarah Morris
Eric Murphy
Gretchen Navidi
Liz Necka
Nicole North
Katherine Noveras
Stephen O’Connor
Obianuju Onyechi
Anna Ordóñez
Heather Ovelmen

Jenni Pacheco
David Panchision
Jane Pearson
Michele Pearson
Courtney Pinard
Denise Pintello
Greg Portner
Janani Prabhakar
Vasudev Rao
Dianne Rausch
Eve Reider
Melba Rojas
Mary Rooney
Rebecca Rosen
Andrew Rossi
Monica Rowe
Laura Rowland
Matt Rudorfer
Christopher Sarampote
Tanisha Savage
Rachel Scheinert
Aileen Schulte
Brian Scott
Teri Senn
Geetha Senthil
Joel Sherrill
Galia Siegel
Todd Silber
Rita Sisco
Sharon Smith
Abigail Soyombo
Clare Stevens
Leandra Stubbs
Brooke Sydnor
Joanna Szczepanik
Alexander Talkovsky
Adam Thomas
Jeena Thomas
Leo Tonelli
Farris Tuma
Ashlee Van’t Veer
Siavash Vaziri
Aleksandra Vicentic
Clarissa Vincent
Becky Wagenaar-Miller
Ann Wagner
Susan Wetherby
Jeffrey Wiegand
Andrea Wijtenburg
Lois Winsky
Abera Wouhib
Claro Yu
Steven Zalcman

Appendix A

Summary of Primary MH Applications Reviewed
Council: May 2020

IRG Recommendation
Category Scored # Scored Direct Cost $ Not Scored (NRFC) # Not Scored (NRFC)
Direct Cost $
Other # Other Direct Cost $ Total # Total Direct Cost $
Research 666 $939,282,455 509 $606,759,731 0 0 1176 $1,546,042,186
Research Training 1 $2,583,010 0 0 0 0 1 $2,583,010
Career 73 $56,594,835 26 $21,679,596 0 0 99 $78,274,431
Other 0 0 0 0 0 0 0 0
Totals 740 $998,460,300 535 $628,439,327 0 $0 1276 $1,626,899,627

Appendix B

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)
    Chair and Psychiatrist-in-Chief
    Department of Psychiatry
    Boston Medical Center
    Boston, MA
  • Kamilah Jackson, M.D. (23)
    Medical Director
    PerformCare
    Robbinsville, NJ
  • Lisa H. Jaycox, Ph.D. (20)
    Senior Behavioral Scientist
    Health Program
    Rand Corporation
    Arlington, VA
  • Cheryl A. King, Ph.D. (21)
    Professor and Director
    Youth and Young Adult Suicide Prevention Program
    Department of Psychiatry and Psychology
    University of Michigan
    Rachel Upjohn Building
    Ann Arbor, MI
  • Gregory A. Miller, Ph.D. (20)
    Distinguished Professor
    Department of Psychology
    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)
    Director
    Marketing and Communications
    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

Alex Azar
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

Liaison Representative

Anita Everett, M.D., DFAPA
Acting Director, Center for Mental Health Services
Substance Abuse and Mental Services Administration
Rockville, MD