NAMHC Minutes of the 274th Meeting

Introduction

The National Advisory Mental Health Council (NAMHC) held its 274th meeting at 12:30 pm, September 17, 2024, in person and via Zoom and National Institutes of Health (NIH) videocast. In accordance with Public Law 92-463, the session was open to the public until approximately 4:45 pm and was followed by the closed session on September 18, 2024. Shelli Avenevoli, Ph.D., Acting Director of the National Institute of Mental Health (NIMH), presided as Chair for both sessions.

OPEN PORTION OF THE MEETING

1. Open Policy Session Call to Order & Opening Remarks, Shelli Avenevoli, Ph.D. ( NIH Videocast @00:03)

   Acting NIMH Director Dr. Shelli Avenevoli opened the hybrid NAMHC meeting and welcomed Council members (Appendix A), NIMH staff, NIH staff, and members from various constituent communities. Dr. Avenevoli announced her role as Acting Director of NIMH while NIH conducts a national search for the next permanent NIMH Director. Following a review of in-person and virtual meeting etiquette, the Council unanimously passed a motion approving the final Summary Minutes of the May 2024 meeting.

2. NIMH Director’s Report, Shelli Avenevoli, Ph.D., and Phyllis M. Ampofo, M.P.H. ( NIH Videocast @04:50)

   1. Congressional Interactions

      Ms. Ampofo, NIMH Legislative Director, reviewed NIMH engagement with Congress, including participation in congressional briefings and responses to requests for information on topics such as children’s mental health research, autism spectrum disorder, hoarding disorder in older adults, mental health and juvenile justice, suicide prevention, and the impact of technology and digital media on youth mental health and development. NIMH leadership participated in two webinars for congressional staff, led by the NIH Office of Legislative and Policy Analysis (OLPA). On July 16, 2024, representatives of the Bipartisan Senate Mental Health Caucus attended a roundtable discussion on children’s mental health research, with leadership participation from NIMH, the National Institute on Drug Abuse (NIDA), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). On September 13, 2024, representatives of the House Democratic Caucus toured NIMH and attended a roundtable discussion with the NIH Director, Monica Bertagnolli, M.D.

   2. Appropriations and Budget Updates

      In March 2024, Congress passed and President Joe Biden signed the Consolidated Appropriations Act of 2024 and the Further Consolidated Appropriations Act of 2024 , the latter providing $48.6 billion for NIH, which included $2.3 billion for NIMH, for the Fiscal Year 2024 (FY24). NIMH’s budget included an increase of $75 million targeted for accelerating improved diagnostics, therapeutics, and treatments, as well as enhanced precision mental health care through NIMH’s new Precision Psychiatry Initiative and studies on social media’s impact on mental health. In July 2024, the House Appropriations Committee approved the FY 2025 Labor, Health and Human Services, and Education Subcommittee bill, which maintained the FY 2024 budget of $48.6 billion for NIH and $2.3 billion for NIMH. In August 2024, the Senate Appropriations Committee approved their corresponding FY 2025 bill providing an increased budget of $50.4 billion for NIH and $2.7 billion for NIMH, which would restore funding to the NIH Innovation Projects. NIMH anticipates funding more than 600 new and competing research projects in FY 2024, representing a success rate of 22 percent.

   3. HHS and NIH Updates

      Dr. Avenevoli announced NIH leadership changes, including the appointment of Geri R. Donenberg, Ph.D., as NIH Associate Director for AIDS Research and Director of the NIH Office of AIDS Research, as well as Carolyn M. Hutter, Ph.D., as Director of the NIH Office of Strategic Coordination.

      Dr. Avenevoli noted several NIH activities that occurred in summer 2024. In June, NIH hosted the 10th Annual Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative Conference , celebrating a decade of innovation. The Accelerating Medicines Partnership® Program – Schizophrenia (AMP® SCZ) held its Annual Investigators Meeting and Pre-Meeting Hackathon, and NIMH published the second AMP® SCZ dataset to the NIMH Data Archive.

      The All of Us Research Program published its Scientific Priorities Roadmap . As of July 2024, data from the All of Us Research Program was made available to commercial organizations via the All of Us Researcher Workbench . The NIH Community Partnerships to Advance Science for Society (ComPASS) program and the NIH Community Engagement Alliance Consultative Resource (CEACR) hosted a series of webinars providing professional development for community organizations to conduct research. The Interagency Autism Coordinating Committee (IACC) held a full committee meeting on July 10, 2024 and published its FY 2019-2023 Report to Congress on Activities Related to Autism Spectrum Disorder and Other Developmental Disabilities Under the Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2019 . Congress introduced legislation to reauthorize the Autism CARES Act. If enacted, HHS will solicit applications for public members for the next iteration of IACC.

      On August 28, 2024, the Office of the Surgeon General issued an Advisory on Mental Health and Well- Being of Parents . The NIH Common Fund issued a Request for Information (RFI) to solicit public feedback on developing artificial intelligence (AI) algorithms for clinical decision-making. The NIH Office of Science Policy issued a new resource to guide AI-related research. Finally, Dr. Avenevoli highlighted upcoming changes to the NIH grant application and review process.

   4. NIMH News to Know

      Dr. Avenevoli announced several staff transitions. Nicole Martino was appointed NIMH Executive Officer, Deputy Director for Management, and Director for the Office of Management. Susan Koester, Ph.D., was appointed Acting NIMH Deputy Director; Suzanne Garcia, Ph.D., Acting Deputy Director for the Division of Neuroscience and Basic Behavioral Science; Jovier Evans, Ph.D., Acting Senior Advisor in the NIMH Office of the Director; Oni Celestin, Ph.D., Deputy Director of the Office of National Autism Coordination; Eugene Kane, Dr.P.H., M.P.H., Deputy Director of the Office of Clinical Research; and Haniya Raza, D.O., M.P.H., Deputy Clinical Director of the Intramural Research Programs. Charisee Lamar, Ph.D., M.P.H., R.R.T., departed from her position as Deputy Director of the Division of Extramural Activities.

      Dr. Avenevoli provided an update of applicant demographics and award rates spanning fiscal years 2014-2023.

      NIMH will conclude its 75th Anniversary celebration on September 20, 2024 with a final symposium. NIMH, NICHD, and the National Institute on Minority Health and Health Disparities (NIMHD) awarded 24 youth participating in the 2024 Speaking Up About Mental Health Essay Contest.

   5. Science Highlights

      Dr. Avenevoli shared three science highlights. The first study1 examined the link between brain cognition and brain networks in individuals with or at risk of early psychosis. Using data from the Human Connectome Project for Early Psychosis, investigators found that cognitive performance was linked to prefrontal-somatomotor connectivity in individuals with early psychosis. Investigators confirmed their findings using data from the North American Prodrome Longitudinal Study on individuals at high risk for psychosis, which showed an even stronger relationship between cognitive performance and prefrontal- somatomotor connectivity, but only among those who later developed a psychotic disorder. This finding is important for guiding the early detection and treatment of psychotic disorders.

      The second study2 used secondary data to assess whether a stepped care intervention differentially improved post-traumatic stress disorder (PTSD) among a range of populations. Findings suggest that the brief stepped collaborative care intervention was associated with greater six-month reductions in PTSD symptoms among non-White Hispanic patients than non-Hispanic White patients.

      The third study3 was a follow-up to a NIMH roundtable on preteen suicide. Investigators looked at national mortality data from 2001 to 2022. There were 2,241 suicides among preteens aged 8 to 12 during this period, representing an 8 percent increase annually. The increases were highest among female, American Indian/Alaska Native, Asian/Pacific Islander, and Hispanic preteens. Although Black preteens had the highest overall suicide rate, Hispanic preteens had the greatest increase. Investigators also reported on methods used among this population. Dr. Avenevoli emphasized that NIMH was tracking these alarming trends and published several Requests for Applications to better understand these findings.

      Discussion

      Following Dr. Avenevoli’s update, a Council member asked about the implications of decreased funding for the BRAIN Initiative and the All of Us Research Program. They also suggested monitoring trends related to the NIH Data Archive. Council members expressed concern about the rise in suicide among preteens and recommended increased engagement with youth, who are often motivated to promote rapid change.

      Dr. Avenevoli thanked Council members for their suggestions. She answered that while budget decreases had slowed the pace of the All of Us Research Program, not restoring the base funding for the BRAIN Initiative could have a critical impact on the number of new awards next year. She reiterated NIMH’s commitment to suicide prevention and its role in sharing research findings with other federal agencies and community organizations. She expressed interest in engaging with youth and young adult advisory groups to build momentum for suicide prevention efforts

3. Comments from Retiring Members, ( NIH Videocast @01:09:43)

   Dr. Avenevoli announced that eight Council members would be retiring: Ted Abel, Ph.D., Pamela Collins, M.D., M.P.H., Amy Kilbourne, Ph.D., M.P.H., Marguerita Lightfoot, Ph.D., Joel Nigg, Ph.D., Matthew Nock, Ph.D., Patricia Recupero, M.D., J.D., and Bryan Roth, M.D., Ph.D. She invited the six attending Council members to share their parting thoughts. The retiring Council members expressed their gratitude for serving NIMH’s important mission, for the important work that NIMH conducts, and for the support they received from NIMH staff. Each also used the opportunity to highlight areas of interest they would like to see for the future of NIMH.

4. Division of Services and Intervention Research (DSIR): A Progress Report, Patricia Areán, Ph.D., Director, DSIR ( NIH Videocast @01:27:40)

   Dr. Areán provided an overview of DSIR funding activities since 2016. She indicated that DSIR is responsible for supporting the acceleration of the translation of research; testing novel treatments for their efficacy, effectiveness, and deployability; understanding how to transform care provision, settings, and systems; and recognizing how policy and payment models impact access to high-quality mental health care. The division’s extramural budget represents 13 percent of NIMH’s extramural budget. The division receives an average of 400-500 applications per year, with an uptick in 2020 due to funding announcements related to the COVID-19 pandemic and the ethical use of digital data. The K awards have steadily increased, with a high of 60 applications in 2023. In May 2024, DSIR released an RFI to better understand the scientific and public health policy barriers that investigators experience. Currently, DSIR is also completing a literature review and internal portfolio analysis to better understand the impact of DSIR’s work. Dr. Areán posed questions to Council about the communication tools used to publicize DSIR research opportunities, the barriers to applying to DSIR grants, emerging areas of science DSIR may explore, and gaps in the field.

   In terms of emerging areas, Council members suggested prioritizing the intersections of implementation science and intervention science, in addition to psychiatric research in school settings. Additionally, they recommended training early investigators in systems thinking to support the translation of complex interventions in real-world settings. In terms of gaps in the field, a Council member recommended policy research to connect rural areas or other settings with limited broadband to mental health care. Another Council member recommended that DSIR develop a pathway for psychosocial interventions to quickly move into the Food and Drug Administration (FDA) and insurance reimbursement processes. Later, a Council member inquired whether DSIR partners with other federal agencies on funding announcements.

5. Concept Clearances ( NIH Videocast @02:12:34)

   1. Navigator Emergency Department Diversion Models for Non-Urgent Mental Health Concerns,
      Mary Acri, Ph.D., DSIR

      Dr. Acri reviewed trends and disparities related to emergency department (ED) use for non-urgent mental health care. Specifically, EDs were perceived as a primary point of entry into mental health services, but patients and families were unlikely to see a mental health professional, receive meaningful mental health supports, or obtain a referral for services. The goal of this concept is to encourage research on patient navigation diversion models, which have the potential to promote treatment engagement and adherence, lessen access disparities, and monitor outcomes over time. This research would also address how, why, and for whom these models work to scale, promote adoption, and develop a pathway from ED to community mental health services.

      Discussion
      Discussants: Dr. Rinad Beidas and Dr. Pamela Collins

      Dr. Beidas raised questions to help refine this concept, including the need to fully understand why parents visit the ED, broaden the definition of patient navigation and the settings in which it can occur, and address the payment and care team integration challenges that community health workers and specialists face. Dr. Collins asked whether the aim was to deflect patients from the ED into community health settings. Other Council members commented on the challenge of meeting families’ needs for an immediate assessment and intervention, the potential of missing small and rural communities that may be the most informative to this effort, and the need for partnerships with SAMHSA and payers.*

   2. Accelerating Solutions to Improve Access and Quality of Empirically-Supported Practices for Youth Mental Health,
      Marcy Burstein, Ph.D., DSIR

      Dr. Burstein provided an overview of the barriers that youth face when accessing mental health services, such as unsuitable interventions, extensive waitlists, fragmented services, and a lack of decision support tools. The goal of this concept is to encourage research to address these barriers; support the development and evaluation of scalable, empirically-supported mental health services for youth; and address disparities in access.

      Discussion
      Discussants: Dr. Velma McBride Murry and Dr. Rinad Beidas

      Dr. Murry expressed concern over the wide scope of the concept and noted that the National Academies of Sciences, Engineering, and Medicine would be publishing a blueprint for youth mental health that could be helpful. Dr. Burstein clarified that the intent was to address the youth mental health crisis with urgency, using a broad, multi-pronged approach that addressed several barriers simultaneously. Dr. Beidas highlighted the term empirically-supported treatments, which might not adequately address patient and provider preferences, and suggested including a focus on systems- and structural-level interventions. Council members suggested including a focus on embedded and integrated care models in community settings, scaling best practices, and addressing perceived barriers to delivering care.

   3. Laboratories to Optimize Digital Health, Adam Haim, Ph.D., DSIR

      This concept extends an existing initiative that funded digital mental health technology. Dr. Haim said that most studies from the existing initiative had not moved into the effectiveness-implementation stage. In contrast, commercially-developed digital technologies for mental health were developed rapidly, but too often without an evidence base. The aim of this extension is to promote partnerships between academic and commercial researchers to stimulate the development of evidence-based digital mental health technologies and to establish laboratories to test and refine digital health applications.

      Discussion
      Discussants: Dr. Olu Ajilore and Dr. Jyotishman Pathak

      Dr. Ajilore recommended ensuring the technologies were accessible and asked whether the concept would become part of the Small Business Technology Transfer (STTR) program. Dr. Haim answered that there would be a parallel STTR program, but that this concept aimed to include larger businesses. Dr. Pathak suggested an emphasis on validation and field testing, fairness, and bias in the context of AI, and sustainability. Council members suggested targeting commercial partners with populations with limited resources, considering the societal impact of certain technologies such as chatbots, and ensuring that engagement was demonstrated before moving forward with a technology.

   4. Discovery of Proteins and Metabolites Implicated in Mental Illness and Neurodevelopmental Disorders, Adam Haim, Ph.D., DSIR

      Dr. Nadler said this concept was developed from the PsychENCODE Consortium, which aimed to map non-coding gene regulatory variation in postmortem human brains. While studies under PsychENCODE provide a starting point for understanding biological mechanisms of genetic risk, most do not go beyond the RNA level. To better understand the molecular metabolites involved in crucial cellular functions, it is important to directly study proteins and metabolites. The aim of this concept is to address this gap by encouraging the analysis of altered proteins and metabolites involved in mental illness and neurodevelopmental disorders.

      Discussion
      Discussants: Dr. Ted Abel and Dr. Laura Scott

      Dr. Roth suggested including a focus on mice models rather than induced pluripotent stem cells (iPSC) neurons that tend not to express meaningful levels of targeted receptors. Dr. Abel encouraged consideration for neural plasticity and experience but acknowledged the challenges of studying plasticity in post-mortem brains and iPSC cells. He suggested that some funds be directed toward brain banks to enable studies on new spatial metabolomics. Dr. Scott recommended controlling for cell-type composition when testing across multiomics, testing multiomics data on the same samples to increase study power, and including guidance on duplication across different tissues to evaluate reproducibility.

   5. Optimizing Treatment Strategies for Adult Attention-Deficit Hyperactivity Disorder (ADHD), Matthew Rudorfer, M.D., DSIR

      Dr. Rudorfer talked about how adult ADHD remains understudied despite an understanding that ADHD does not end after childhood but rather evolves over the lifespan. Although stimulant medication is considered standard treatment for ADHD, it is not suitable for everyone. This concept aims to assess the effectiveness of current non-stimulant treatments in adults with ADHD, such as non-stimulant medications approved for pediatric ADHD, repurposed dopaminergic medications, trigeminal nerve stimulation, and cognitive behavioral therapy.

      Discussion
      Discussants: Dr. Joel Nigg and Dr. Angus MacDonald

      Dr. Nigg suggested allowing applicants to provide empirically-based ideas for assessing adult ADHD because current diagnostic criteria were developed for children. Additionally, he suggested that funding announcements focus on identifying treatment targets, widening the scope of drug therapies, and emphasizing psychotherapies and multimodal approaches. Dr. MacDonald added that FDA involvement early in the research process would help shorten the pathway from experiment to clearance. He also suggested that similar treatments, such as cognitive training, may be good targets to include. Council members noted the need to include a cardiovascular safety assessment for medications, as well as to explore differences across cultures early versus older adults, and urban versus rural subgroups.

6. Public Comment ( NIH Videocast @03:33:53)

   There was one written public comment (See Appendix D) and no oral public comments.

7. Adjournment

   Dr. Avenevoli adjourned the open session of the meeting at 4:45 pm.

CLOSED PORTION OF THE MEETING

This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., and section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001- 1014).

Tracy Waldeck, Ph.D., Executive Secretary of the Council, explained policies and procedures regarding confidentiality and conflict of interest to the members of the Council.

Members absented themselves from the meeting during the discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

1. Review of Applications

   Refer to Appendix E

2. Adjournment

   Dr. Avenevoli adjourned the closed grant review session of the meeting at 11:23 am.

   EX OFFICIO MEMBERS

   Office of the Secretary, DHHS
   Xavier Becerra, J.D.
   Secretary
   Department of Health and Human Services
   Washington, DC

   National Institutes of Health
   Monica M. Bertagnolli, M.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 (QUERI)
   U.S. Department of Veterans Affairs
   Professor of Learning Health Sciences
   University of Michigan Medical School
   Ann Arbor, MI

   Liaison Representative
   Anita Everett, M.D., DFAPA
   Director
   Center for Mental Health Services
   US, HHS Substance Abuse and Mental Health Services
   Rockville, MD

Others Present In-Person for Open Session:

Perry Kirkham, Purdue University

Alyana Marleton, Federation of Associations in Behavioral and Brain Sciences

Abram Rosenblatt, Westat

Sabrina Sito, Federation of Associations in Behavioral and Brain Sciences

Others Present Virtually for Open Session:

Marie Rowland, Science Writer

Edie Eaton, Captioner

Jeffrey Cozart, NIH Videocast

Charlie Bird, NIH Events Management

Aimee Oczkowski, Webinar Support

Appendix D

Public Comment

September 10, 2024

Re: Restriction of the Forced Swim and Tail Suspension Tests; September 17, 2024, National Advisory Mental Health Council (NAMHC) Open Policy Session Written Comment

Dear Director Avenevoli and members of the NAMHC:

On behalf of the Physicians Committee for Responsible Medicine (PCRM), a nonprofit health advocacy organization supported by nearly one million members and supporters worldwide, thank you for the opportunity to comment on this meeting, and for your dedicated and determined work to improve the well-being of individuals with mental illness.

We submitted a comment to the advisory council’s May open policy session in which we highlighted scientific and translational issues with the forced swim test (FST) and tail suspension test (TST), as well as the actions of agencies in the United Kingdom and Australia to prohibit use of the forced swim test. 1,2 Meanwhile, the National Institute of Mental Health (NIMH) publicly acknowledges the failures of these methods, yet seemingly intends on funding their use indefinitely, without measurable, timebound goals for change. A 2019 Director’s Message on the use of animal models in mental health research states that “traditional behavioral responses to stress paradigms are particularly problematic. Non-specific tests such as the forced-swim or tail suspension tests, among others, have largely failed to reveal translatable neural mechanisms, and lack specificity from a pharmacologic-validity perspective.” 3 More recently, a funding opportunity announcement for in vivo preclinical assays of circuit engagement stated: “The poor predictive value of current preclinical screening model systems in therapeutic development for neurological and mental disorders is well recognized by the pharmaceutical industry,” and that the FST and TST “do not reflect specific neural processes or predict efficacy.” 4 Still, NIMH-funded projects persist in the use of these measures. In one example, a manuscript published with NIMH funding sought to assess HIV- associated major depressive disorder using the forced swim test as its measure of depression. 5 In this paper, the authors claim that the test “evaluates despair behavior…with immobility reflecting hopelessness,” contrary to the growing understanding that the test instead reflects an adaptive response to stress. 6 We suggest that restrictions on these tests be included in the Funding Opportunity Description section of new funding opportunity announcements. This language could state that the FST and TST are not to be used as models of depression or anxiety, as measures of ‘depressive-like’ or ‘anxiety-like’ behavior, or as preclinical assays for therapeutics. Additionally, in the cases of well-documented failures of specific methodologies in research such as the FST and TST, NIMH should make public statements and release guidelines regarding which methods are no longer deemed acceptable for funding considerations.

These relatively simple steps would not require a change to the Institute’s position on the utility of these tests, but rather ensure that researchers conform to this position. These changes would also help ensure that NIMH resources go toward the most rigorous and meritorious science, ultimately benefiting patients.

Thank you for the opportunity to share these suggestions and for your efforts to lead mental health research toward more effective practices.

Sincerely,

Stephen Farghali, MSc 
Research Advocacy Coordinator 
Physicians Committee for Responsible Medicine

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