NAMHC Minutes of the 245th Meeting

May 26, 2016

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Institute of Mental Health

Introduction

The National Advisory Mental Health Council (NAMHC) convened its 245th meeting in open policy session at 9:00 a.m. on May 26, 2016, at the Neuroscience Center in Rockville, Maryland, and adjourned at approximately 1:25 p.m. In accordance with Public Law 92-463, the policy session was open to the public. The NAMHC reconvened for a closed session to review grant applications at 2:00 p.m. on May 26, 2016, at the Neuroscience Center in Rockville, Maryland, until adjournment at approximately 5:00 p.m. Bruce Cuthbert, Ph.D., Acting Director, National Institute of Mental Health (NIMH) presided.

Council Members Present at the Grant Review and/or Open Sessions

(Council Roster)

Chairperson

• Bruce Cuthbert, M.D.

Executive Secretary

• Jean Noronha, Ph.D.

Council Members

• Patricia Areán, Ph.D.
• Deanna M. Barch, Ph.D.
• Rhonda Robinson Beale, M.D.
• David A. Brent, M.D.
• Benjamin G. Druss, M.D., M.P.H.
• Hakon Heimer, M.S.
• Michael F. Hogan, Ph.D.
• Richard L. Huganir, Ph.D.
• John Krystal, M.D.
• Marsha M. Linehan, Ph.D. (via telephone)
• Maria A. Oquendo, M.D.
• Gene E. Robinson, Ph.D.
• Mary Jane Rotheram, Ph.D.
• Hyong Un, M.D.
• Christopher A. Walsh, M.D.

Ex Officio Members

• John W. Davison, M.B.A., Ph.D. Department of Defense
• Theresa Gleason, Ph.D., Department of Veterans Affairs

Liaison Representative

• Paolo del Vecchio, M.S.W., Center for Mental Health Services, Substance Abuse and Mental Health Services Administration (SAMSHA)

Others Present at the Open Policy Session

• Melissa Arbuckle, Guest Speaker
• Linda Brzustowicz, Guest Speaker
• Michael Byer, M3 Information
• Erin Cadwalader, Lewis-Burke Associates
• Alex Davies, Transcriber
• Gregory DeLapp, Employee Assistance Professional Association
• Jane Eisen, Guest Speaker
• Kana Enomoto, Guest Speaker
• Craig Fisher, American Psychological Association
• Dionne Hart, Sign Language Interpreter
• Janice Keegan, Sign Language Interpreter
• Dytrea Langon, Synergy Enterprises, Inc.
• Latoyia Piper, Griffin Family Therapy
• David Ross, Guest Speaker
• Tanya Shuy
• Paula Skedsvold, Federation of Associations in Behavioral and Brain Sciences
• Michael Travis, Guest Speaker
• Aaron Walker, National Association of State Mental Health Program Directors
• Lori Whitten, Science Writer
• TaRaena Yate, Synergy Enterprises

Open Policy Session Call to Order and Opening Remarks

NIMH Acting Director Bruce Cuthbert, Ph.D., called the open policy session to order and welcomed all in attendance. Dr. Cuthbert also welcomed members of the public attending via National Institutes of Health (NIH) VideoCast.

Approval of Minutes of the Previous Council Meeting

Turning to the minutes of the February 2016 Council meeting, Dr. Cuthbert asked whether Council members had any comments, revisions, or questions. Receiving none, the Council unanimously passed the motion to approve the minutes.

NIMH Director’s Report

Dr. Cuthbert provided updates on activities related to NIH and NIMH.

Dr. Cuthbert reviewed the NIH Clinical Center Working Group Red Team Report on Reducing Risk and Promoting Patient Safety in the Intramural Program , released on April 21, 2016. In May 2015, the U.S. Food and Drug Administration (FDA) inspected the Clinical Center’s Pharmaceutical Development Section (PDS) and Intravenous Admixture Unit (IVAU) in response to various concerns. NIH announced its response plans, and suspended sterile activities in the PDS the following month. An NIH Internal Task Force recommended the formation of an NIH Clinical Center Working Group Red Team to report to the Advisory Committee to the NIH director. This Red Team is comprised of distinguished experts from outside and within the NIH, and is charged with making recommendations about ways to enhance the organization, financing, and management of the Clinical Center to improve the quality of patient care and reduce risks associated with clinical research and research-related activities.

In the area of safety and quality, the recently released Red Team report recommended that NIH: 1) adopt a new Clinical Center mission and values statements that reflect synergism of science and safety; 2) establish a Research Support and Compliance Office; and 3) develop systems to monitor, report, and enforce safety and quality standards. The report indicated that the Clinical Center functioned as a loosely confederated group, with unclear lines of authority. In the area of leadership, the report recommended that NIH: 1) establish an external hospital board; 2) strengthen leadership and responsibility to centralize authority for clinical research, clarify responsibilities of Clinical Center leadership, and integrate patient safety in individual performance plans; 3) establish a Clinical Practice Committee; and 4) identify and eliminate potential gaps among clinical services. In the area of sterile processing, the report recommended that NIH: 1) should not rebuild the sterile PDS in the Clinical Center; 2) enhance resource sharing across Institutes and Centers; 3) ensure IVAU and non-sterile PDS are fully remediated; and 4) assess all facilities at NIH producing sterile materials. Laura Forese, M.D., M.P.H., is now the External Clinical Center Board Chair, and Kathryn C. Zoon, Ph.D., is the Interim Compliance Office Director.

Dr. Cuthbert provided an update on the NIMH Positron Emission Tomography (PET) Radiochemistry Facility. NIH initiated an inspection by a manufacturing-grade inspector on April 19, 2016. The PET lab passed previous internally- initiated outside inspections in 2014 and earlier in 2016; it was compliant with USP 823, the set of standards applied to research labs for PET radiochemistry. However, the manufacturing-grade inspection uncovered the possibility of contamination from mold or fungus, although none was found. This led to an NIMH decision to permanently close its PET radiochemistry facility for production of radioligands for humans. The PET laboratory Director notified the IRB and the FDA, and closed all Investigational New Drugs (INDs) with product from this lab. NIMH notified participants who were injected with product from the laboratory during the prior year. Notifications were sent via mail on April 22, 2016. Further tests were all negative for the presence of mold. Future radiosyntheses will take place in the new NIH Clinical Center Current Good Manufacturing Practices (CGMP) PET facility, as has been planned for the past three years. The scope of the PET laboratory closure included 17 active protocols, 13 INDs, and 53 adult subjects injected throughout the prior year. There were no signs or symptoms of any infectious illness among participants who received injections for PET scans. Suspension of PET studies had no impact on subsequent care or treatment of any patient. Dr. Cuthbert remarked that NIMH will continue to report the progress on the Clinical Center and NIMH PET laboratory. He praised the responses by the NIH and NIMH teams.

Dr. Cuthbert noted that the search for a new NIMH Director closed on February 8, 2016. Walter Koroshetz, M.D., Director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, M.D., Director of the National Institute on Drug Abuse, led the search committee. The search committee aims to name a new NIMH Director by early autumn of 2016.  To prepare for a new Director, NIMH staff members are developing a book with Division and Office portfolios and initiatives, key leadership personnel, metrics, and stakeholders and collaborators. This resource will also outline NIMH’s current business practices and operations, and will discuss the Institute’s Strategic Plan implementation. NIMH released a Request for Information  to invite brief perspectives on the state of mental health research.

Turning to the budget, Dr. Cuthbert noted that the NIH fiscal year (FY) 2016 budget is $32.3 billion, which represents an increase of more than $2 billion from FY 2015. The FY 2016 NIH budget includes funding for special initiatives, such as the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative , Alzheimer’s research, and the Precision Medicine Initiative . Dr. Cuthbert reported that the NIMH FY 2015 actual budget is $1.434 billion, and the operating plan for FY 2016 is $1.519 billion, representing a 5.9 percent ($85 million) increase. This is a general increase of $52.5 million, with a $27.9 million increase for the BRAIN Initiative and a $4.6 million increase for AIDS. Small Business Innovation Research (SBIR) has an increase of 12.2 percent (this is a statuary set-aside), and although Congress is encouraging investment, it can be difficult to find small businesses that are competitive in this area. Regarding the FY 2017 budget, more information is coming, and a continuing resolution is a possibility.

An NIMH staff member recently transitioned to a new position. Meredith Fox, Ph.D., was named Acting Director for the Office of Science, Policy, Planning, and Communications (OSPPC). NIMH is awaiting NIH approval of her official appointment as Director of OSPPC.

Three NIMH grant awardees received the Presidential Early Career Award for Scientist and Engineers (PECASE). PECASE was established in 1996 and is the highest honor bestowed by the United States Government on science and engineering professionals in the early stages of their independent research careers. In 2016, 20 NIH-funded recipients were awarded, and of these, 3 receive funding from NIMH. The NIMH-funded recipients were Kafui Dzirasa, Ph.D., of Duke University, Tina Goldstein, Ph.D. of the University of Pittsburgh, and Sachin Patel, M.D., of Vanderbilt University.

Dr. Cuthbert then provided a brief update on Council Workgroups. The Behavioral/Social Sciences Research Workgroup is reviewing the opportunities and challenges of using new information technologies to study human behaviors relevant to the NIMH mission. The Workgroup met on March 7 and discussed the technologies needed to understand the life course and etiology of disorders, to predict and prevent mental illness, and to achieve more efficient and effective diagnosis and treatment. The Workgroup will meet again on June 13. Dr. Cuthbert thanked Patricia Areán, Ph.D., and Alan Leshner, Ph.D., for co-chairing the Workgroup, and expressed gratitude to all members of the Workgroup. The Workgroup on Research Domain Criteria (RDoC) Tasks and Measures is charged with developing a list of recommended tasks and measures for each of the constructs. The Workgroup met on April 5–6 and developed an initial list of measures for most constructs. Dr. Cuthbert thanked Deanna Barch, Ph.D., and Maria Oquendo, M.D., for co-chairing the Workgroup, and expressed gratitude to all the members of the Workgroup. Additionally, the Foundation of the NIH Biomarkers Consortium met to discuss reward-related measures for trials.

Dr. Cuthbert proposed the formation of a new Council Workgroup to advise the NIMH on modifications to the RDoC matrix. This Workgroup will evaluate the evidence for a modification of the matrix and will recommend how to include modified information. Modifications can include additions, deletions, or changes to the domains or constructs of the matrix. The timeframe will be approximately three years, and the Workgroup will meet as suggested modifications to the matrix are proposed. Dr. Cuthbert asked for volunteers for the Workgroup and noted that the first organizational meeting will likely be held via teleconference. Incoming Council member Gregory A. Miller, Ph.D. and David Brent, M.D., will co-chair the new Workgroup. People who are not on the Council can also become members of the Workgroup.  

A notable scientific highlight comes from work on the mechanism of action of ketamine metabolites, which have a rapid anti-depressant effect (see PMID 27144355 ). Work in animal models indicates that the metabolism of (R,S)-ketamine to (2S,6S;2R,6R)-hydroxynorketamine (HNK) is essential for its antidepressant effects. Researchers supported by NIMH, NIA, and NCATS demonstrated that the (2R,6R)-HNK enantiomer (R-KET) exerts behavioral, electroencephalographic, electrophysiological and cellular antidepressant-related actions in mice from 1 to 24 hours. They found that these antidepressant actions are independent of R-KET’s action on NMDAR glutamate receptors. Rather, R-KET’s effects involve early and sustained activation of AMPA receptors. The team also showed that R-KET lacks ketamine-related side effects. There was a strong sex effect, with a greater anti-depressant action in females than males. Dr. Cuthbert commented that these new discoveries have obvious and promising clinical implications and that the work was a good example of collaboration among NIH institutes.

Dr. Cuthbert reviewed the meeting agenda and welcomed discussion among the Council members.

Discussion

Tirin Moore, Ph.D., asked whether the NAPLS project collects measures related to biotypes. Dr. Cuthbert noted that this is a good question. Although the project probably does not collect biotype information specifically, it is harmonizing data with international prodrome efforts.

Rhonda Robinson Beale, M.D., asked whether private payers are involved in the RAISE expansion. Although the states and Medicaid are involved, with the Affordable Care Act, patients are seeking care in the private market. She inquired about the presence of a virtual quality tool so that learning can be passed to others across the country to teach providers about new treatments. Dr. Cuthbert responded that although few private payers are currently covering coordinated specialty care, interest in doing so will probably increase. Robert Heinssen, Ph.D., Director of the NIMH Division of Services and Interventions Research, remarked that the process is still unfolding. Early in the process, NIMH engaged the Centers for Medicare & Medicaid Services (CMS). CMS accepted the data as sufficient for support of coordinated care for schizophrenia through Medicaid. With that foundation in place, now is a good time to start conversations with private payers. The virtual component of EPINET will be driven by data analysis and feedback to clinics. An associated national organization of providers and scientists are interested in applying this research to improve the quality of care. Steven Adelsheim, M.D., of Stanford University leads that group, which will disseminate the information and create a knowledge network.

Marsha Linehan, Ph.D., wondered whether there is any research on patients who show brain patterns related to psychosis but do not display psychotic behaviors. Dr. Cuthbert commented that this question relates to the cognitive reserve hypothesis and that there are researchers examining interventions to prevent or delay the onset of psychosis. Dr. Heinssen added that bringing the data from this research together will allow scientists to address this question. Research from the Human Connectome Project  also points to neuroplasticity and the possibility that cognitive control and inhibition could be modulated among this population. Across several areas, the research on schizophrenia is promising.

DHHS Initiatives Addressing Serious Mental Illness

Kana Enomoto, M.A.
Principal Deputy Administrator
Substance Abuse and Mental Health Services Administration (SAMHSA)

SAMHSA is a proud partner with NIH Institutes and other agencies on the Department of Health and Human Services (DHHS) Behavioral Health Coordinating Council (BHCC). The BHCC shares information and identifies and facilitates collaborative, action-oriented approaches to address the DHHS behavioral health agenda without duplication of effort across the Department. This group developed the DHHS action plan on serious mental illness (SMI) chaired by Ms. Enomoto and Dr. Cuthbert, and supported by SAMHSA’s Paolo del Vecchio, M.S.W., and NIMH’s Robert Heinssen, Ph.D.

The DHHS/BHHC action plan aims to reduce the duration of untreated SMI in individuals through early engagement in care soon after these conditions arise. Other goals are to improve the quality of care through stronger measurement and accountability and increased access to community-based treatment and support services. Richard Frank, Ph.D., Assistant Secretary for Planning and Evaluation at DHHS, is a major supporter. According to the 2014 National Survey on Drug Use and Health, 5 percent of women and 3.1 percent of men aged 18 or older reported SMI during the past year. People with SMI are three times more likely than individuals without SMI to be on Medicaid. Therefore, it is critical to ensure that the care provided through Medicaid is of high quality and offers preventive services. Among individuals on Social Security Disability Insurance (SSDI), a large percentage are enrolled due to a primary impairment associated with a diagnosis of a mental illness. Approximately half of the enrollees on SSDI are under the age of 50. Therefore, SMI-related issues have an impact on the economy, and are not only a matter of science and health. Health insurance status influences access to treatment, and too many individuals are not getting needed care despite high expenditures on care. The Nation spends more than $100 billion annually on the costs of direct treatment for mental illness. This figure does not include the significant indirect costs (e.g., loss of productivity, impact on families, and costs borne by other systems such as criminal justice and child welfare).

The average time it takes for an individual experiencing first episode psychosis, an early feature of several SMIs, to enter treatment is more than three years. Yet, research indicates that earlier intervention improves quality of life and that the duration of untreated psychosis moderates response to evidence-based care (see PMID 26481174 ). In addition, 40 percent of people with SMI have a co-occurring substance use disorder. The prevalence of SMI and co-occurring substance use disorder is one reason SAMHSA Centers try to work as seamlessly as possible to ensure that people get the care they need. Further, Ms. Enomoto noted that in 1955, 27 percent of people with SMI were institutionalized compared with 7 percent today. Importantly, there have been no attributable increases in crime or violence associated with these populations.

With these data, NIMH leadership played a major role in speeding the translation of science into practical changes to reduce the duration of untreated SMI. For example, SAMHSA’s Mental Health Block Grant set-aside aims to accelerate the implementation of evidence-based coordinated specialty care for first episode psychosis based on data obtained from NIMH-funded research. The number of states with early psychosis intervention plans continues to grow. However, some states are not able to provide fully coordinated specialty care programs. President Barack Obama proposed an expansion of the initiative so all states can have robust programs. There has been great progress in the translation of research on SMI treatment to practical care and positive change. Progress is enhanced by Federal partnerships, and DHHS hopes to further reduce the typical timeframe from first episode psychosis to treatment.

Current activities in mental illness care include early engagement to help young people who are struggling with mental illness and Healthy Transitions Grants to help navigate a particularly challenging time of life (ages 16 to 25). These programs aim to ensure that these individuals get the support they need. SAMHSA helps communities get supports in place and raise awareness about behavioral health during transition years. Other efforts focus on improving the quality of care through Section 223 and planning grants for Certified Community Behavioral Health Clinics (CCBHCs). These efforts are designed to help improve parity on reimbursement and increase flexibility to provide evidence-based services. Currently, CCBHCs are a demonstration program, and SAMHSA is working to implement and evaluate them in communities that do not currently have such facilities. Efforts here are critical to address chronic diseases among people with SMI, and there has been some progress toward this goal.

Other SAMHSA programs that address SMI include those designed to increase access to community-based services (e.g., Children’s Mental Health Initiative, Primary Behavioral Health Care Integration, Programs for Assistance in Transition from Homelessness, and Cooperative Agreements for the Benefit of Homeless Individuals). SAMHSA also supports state-level efforts in this area.

The Medicaid program also has a significant role in behavioral health services. Medicaid is the largest payer for mental health services in the United States, representing 27 percent of all mental health treatment. Comprehensive services for individuals with SMI are available through Medicaid. Many services are optional, so states have considerable flexibility in benefit design. During the past six years, the Centers for Medicare & Medicaid Services (CMS) developed an approach that encourages states to adopt practices that improve outcomes for beneficiaries with conditions related to mental health and substance use disorders. Listening sessions continue so DHHS can understand and meet the needs of communities. In closing, Ms. Enomoto commented on the tremendous work at DHHS to address SMI and emphasized the importance of partnerships among agencies in these efforts. She welcomed questions and feedback.

Discussion

Rhonda Robinson Beale, M.D., praised DHHS work and activities on SMI. She wondered about creating meaningful connections to further these efforts. Implementing the findings of the Recovery After an Initial Schizophrenia Episode Project (RAISE) is important. With the Affordable Care Act and expansion of health care coverage for people aged 18 to 26, more individuals with SMI will be initially identified in private care. Dr. Areán added that this fact highlights the value of partnering with private insurers. It is important to identify providers who are implementing the RAISE program so we can reach individuals with SMI earlier. There are other initiatives that use health plans that cover the Medicaid and Medicare populations, which set guidelines and performance criteria, to disseminate and influence the adoption of evidence-based treatments.

Ms. Enomoto agreed that many young people with SMI are covered by private care and that DHHS needs to work with commercial providers. SAMHSA has tended to focus on the public sector in the past, and she welcomed suggestions on how the agency can best liaise with private providers. There might also be opportunities to work with private providers in other areas (e.g., medication-assisted treatment) and raise the bar for all in a way that care is seamless across systems.

Dr. Robinson Beale suggested that the Association for Behavioral Health and Wellness may help bridge this gap. The treatment of adolescents will always require outreach to the public sector, as offerings in private care are not always as expansive as they could be. Pay for performance is the future, and it is important to develop criteria and performance metrics in behavioral health care.

Benjamin G. Druss, M.D., M.P.H., asked how DHHS defines SMI. He noted that other groups are refining this definition. Mr. del Vecchio replied that the definition relies on both a diagnostic and functional approach that looks at limitations in major life activities. Ms. Enomoto read the BHCC’s definition: “SMI is defined as mental, behavioral, or emotional disorder diagnosable within the past year, and resulting in a serious functional impairment that substantially interferes with or limits one or more major life activities including but not limited to schizophrenia, bipolar disorder and major depression.” SAMHSA provides this guidance to its Block Grant applicants.

Deanna M. Barch, Ph.D., inquired whether there is a plan for treatment adherence in the implementation of RAISE. Many projects work in a controlled setting but not as well in the community because of poor treatment adherence. Ms. Enomoto explained that for its Block Grant, SAMHSA has provided quality metrics and monitors states in their SMI-related activities. States also self-regulate with regard to following protocols. The BHCC has a subcommittee on enhancing quality measurement for behavioral health care.

Michael F. Hogan, Ph.D., remarked that behavioral health care is dynamic and is shifting rapidly from a specialty system to mainstream care. Care is also beginning earlier. These changes raise questions about leadership in primary care and improving collaborative care. The Obama administration has helped advance these issues, but there is a long way to go. There is a significant gap between what we know and what happens in practice. Evidence-based practices in suicide prevention, supported employment, and early intervention for children exposed to trauma all need to be implemented more widely. Behavioral health conditions have a significant impact, and the difference between what is known about them and what is done in practice is stunning. There are effective practices, but not enough people are receiving them. Treatment for behavioral health conditions in primary care is lacking. If the field applied what is known, it would make a big difference. Dr. Cuthbert commented that increasing collaboration between NIH and SAMHSA provides a platform for moving forward, but there is a long way to go.

Dr. Areán remarked that when states are given the responsibility to regulate quality measurement, they typically leave it to counties. However, counties do not receive guidance on quality measures. Funders need to provide guidance, and there are good recommendations on pragmatic quality measurement from the Institute of Medicine and the DHHS Office of the Assistant Secretary for Planning and Evaluation. It is important to have concrete measures that can be reported so funders know that money is spent on provision of quality services. States, counties, and clinics need to report back to funders on these measures. This has been done in Los Angeles County, California. It is not enough to provide funding for implementation; those implementing programs need supports to know they are doing the right things. Dr. Barch expressed concern about self-regulation and noted that asking for quality measures could change how ground-level systems work. Ms. Enomoto agreed and noted that it is not within SAMHSA’s authority to require states to collect measures. However, the agency can provide guidance and work with states on quality measures.

Dr. Robinson Beale wondered whether particular aspects of infrastructure, processes, and measurement might sometimes counter quality implementation. Without quality, the translation of science cannot gain traction in the field and providers do not implement effective services. Ms. Enomoto added that states want to do a good job implementing services, but they often have limited resources, which affects quality. State directors of mental health and substance abuse services, as well as directors of county programs, want to have a conversation about delivering services and quality. The field needs implementation science and partnerships. Dr. Hogan added that SAMHSA has limited funds and can only do so much. In general, there are concerns about simplifying quality measures in health care. Ms. Enomoto commented that behavioral health is trying to learn the language of health care and navigate those systems, while preserving what is best about the field. The two sectors need to engage to arrive at a common language.

Translating Neuroscience into Medical Education: The National Neuroscience Curriculum Initiative (NNCI)—Update and Initial Outcomes

David A. Ross, M.D., Ph.D.
Co-Chair NNCI, Assistant Professor, Associate Program Director,
Yale Adult Psychiatry Residency Program

Melissa Arbuckle, M.D., Ph.D.
Co-Chair NNCI, Associate Professor of Clinical Psychiatry, Co-Director of Resident Education,
Department of Psychiatry at Columbia and the New York State Psychiatric Institute

Michael Travis, M.D.
Co-Chair NNCI, Associate Professor of Psychiatry, Director of Residency Training,
Western Psychiatric Institute and Clinic at the University of Pittsburgh

Jane Eisen, M.D.
Chair, Advisory Board NNCI, Professor of Psychiatry and Chair,
Mt. Sinai St. Luke’s/Mt. Sinai West, New York

Dr. Cuthbert welcomed the panel of speakers from this exemplary program.

David A. Ross, M.D., Ph.D., thanked NIMH for supporting the National Neuroscience Curriculum Initiative (NNCI)’s work (http://www.nncionline.org/ ). He shared an NNCI advertisement for a one-day conference on teaching neuroscience in psychiatry. The Initiative draws inspiration from a blog by former NIMH Director, Thomas Insel, M.D. The blog discussed how the future of psychiatry will be increasingly rooted in clinical neuroscience research findings. During the past three years, there has been exponential growth in the number of high quality scientific articles on psychiatry and neuroscience. Although a majority of directors of graduate medical education (GME) in psychiatry believe it is important to teach neuroscience, few programs actually do so. One reason that this may not have happened yet is because the Accreditation Council for Graduate Medical Education program requirements do not include neuroscience.

One can ask: What impact have these requirements had on psychiatry training programs? The traditional curriculum for 20th century psychiatry may address various aspects of a disorder (e.g., diagnosis and phenomenology, psychopharmacology, and psychotherapy), but may not include neuroscience. An integrative approach that addresses what is happening in the brain is needed, and important elements of understanding the treatment follow. The curriculum should be bringing neuroscience-informed ideas together with other clinical approaches to treatment.

Even if programs sought to teach neuroscience, it would still be difficult. The neuroscience field is extremely dynamic. One can ask: Where and when does it fit in the curriculum? Who is going to teach it? How do we teach it well? Moreover, while lectures are a common approach in GME, much of the information presented in this way is not retained.

In summary, while the traditional GME model involves central regulations that are implemented by individual programs, this approach may not work for modern neuroscience.  The success of GME in the 21st century will require the same type of collaboration and teamwork used to conduct cutting-edge science.

Three years ago, the NNCI was formed with the overarching goal of creating a set of open resources to help improve the teaching of neuroscience in psychiatry. The guiding principles are to maintain an integrative, patient centered approach; to teach well by applying adult learning theory; to create an adaptable frame that can be implemented by anyone, anywhere regardless of resources; and to collaborate across sites and institutions. An overarching objective of the Initiative is that residents will incorporate a modern neuroscience perspective as a core component of every formulation and treatment plan. Another core learning objective is that residents will be able to serve as ambassadors of neuroscience who can thoughtfully communicate findings from the field to different audiences. To help achieve these objectives, the NNCI has created a set of teaching modules, each reflecting one experiential method for how to actively engage students with the material.

Melissa Arbuckle, M.D., Ph.D., explained that stakeholder engagement and relationships with professional organizations are key components of the NNCI’s implementation and dissemination plan. Dr. Arbuckle discussed the NNCI Advisory Board, which is chaired by Jane Eisen, M.D. The Advisory Board comprises major figures in medical education from across the country, who represent diverse programs. The Advisory Board reviews NNCI content under development, provides direct feedback, collects additional feedback from end users, and helps the program formulate future directions. The NNCI also runs an annual faculty development workshop on how to effectively teach neuroscience, at the American Association of Directors of Psychiatric Residency Training (AADPRT) conference. The training is hands-on and interactive. The NNCI has conducted three such conferences to date, all of which have been successful. Such outreach is critical for implementation efforts. Implementation is also bolstered by the fact that all NNCI materials are freely available on the NNCI website. The NNCI also collaborates with leading professional organizations, including the American Psychiatric Association, the Association for Academic Psychiatry, the Society of Biological Psychiatry, and the American College of Neuropsychopharmacology. 

Michael Travis, M.D., described the NNCI outcomes. The number of attendees at the annual NNCI program at the AADRT conference increased from 2014 to 2016, and more than 90 percent said that they are likely to use at least one of the demonstrated approaches. Participants are engaged and say their comfort teaching neuroscience topics has increased. The NNCI currently offers 9 modules with 56 sessions. These involve 40 authors from 22 separate institutions. There are online and print publications about the NNCI’s work. The NNCI works with journals to produce review articles and other case-based materials that will help make cutting-edge neuroscience accessible for residents and general practitioners. The NNCI collaborates with expert scientists to produce videos discussing their work. Traffic to the NNCI website is busy, and people ask to contribute. More than 75 training programs use NNCI content, and the Initiative is forming international collaborations. 

The next steps for the NNCI involve expanding resources, continuing dissemination efforts, furthering faculty development, developing assessment at the level of the individual learner, and continuing to capitalize on technological opportunities. Dr. Travis encouraged everyone to submit content for possible publication on the website. Dr. Eisen praised the team and its amazing efforts, thanked NIMH for its support, and thanked her collaborators for their contributions to the project.

Discussion

Dr. Krystal commented that NCCI has done an incredible job that is very impressive, and other members of the Council agreed. He added that the way the NNCI has approached its work—by conveying the message that neuroscience is not the only important subject and focusing on the ways that neuroscience can improve psychiatrists’ ability to treat patients—is critical to impact on the field. Everyone can have a stake in this, as we need better educated psychiatrists to improve care and advance the field. This project is getting people excited about psychiatry. Not long ago, only 2.9 percent of medical school applicants were interested in psychiatry. This rate is now 5 percent, but there continues to be a great need for more psychiatrists and other behavioral health professionals. Funders, hospitals, and other organizations have a stake in this project.

Marsha M. Linehan, Ph.D., remarked that the program should be extended to psychologists and social workers. These professionals need to know about neuroscience because they treat clients. Dr. Ross responded that the project currently focuses on psychiatry residents, but staff members are mindful that it could be applied with other groups—including clinicians in the community. Other professional groups or educators can go to the NNCI website, which offers free materials. People who use the information should let the NNCI know. He asked members of Council to suggest ways to conduct outreach with the American Psychological Association.

Dr. Eisen remarked that modules integrate psychiatry and psychology by presenting professionals from both fields speaking collaboratively about effective therapies. Dr. Areán commended NNCI on the process; she stated that the field should be training people across disciplines. The NNCI could serve as a general model for professional training. Dr. Robinson Beale agreed and noted that the NNCI model should be replicated for practicing clinicians. She highlighted the importance of recruiting partners, particularly those who work in the recertification of psychiatrists (the American Psychiatric Association), in these efforts. Pay for performance is a powerful tool, and perhaps providers who have been certified in neuroscience might receive more for services. The American Psychological Association’s Practice Directorate is another potential partner.

Dr. Druss commented on the need for pedagogy and evidence-based teaching; that is, the NNCI should gather data and use outcomes to guide implementation. It is important to determine the program’s outcomes and measure them scientifically. Dr. Robinson Beale remarked that it is powerful for the NNCI to present patient cases, and that cases related to particular topics would be a great feature.

NIMH Repository and Genomics Resource (NIMH-RGR)

Linda Brzustowicz, M.D.
Distinguished Professor and Chair
Department of Genetics
Rutgers University

Linda Brzustowicz, M.D., reviewed the history of the NIMH-RGR . NIMH established the NIMH-RGR in 1998 to leverage and increase the value of human genetic samples and data produced through the research it supports. In establishing the NIMH-RGR, NIMH acknowledged that resource sharing would accelerate discovery in this area and that a repository for sharing leads to cost savings. Currently, clinical data and biomaterials from approximately 120,000 participants are available, with more than 200,000 to be available soon. More than 170 studies are represented in 16 collections, which are mostly organized by Diagnostic and Statistical Manual of Mental Disorders (DSM) disorder. However, participants with a wide range of diagnoses are represented within each collection. Dr. Brzustowicz reviewed the organization and key personnel of the NIMH-RGR.

The types of biomaterials and genetic data in the NIMH-RGR include DNA and RNA from whole blood, plasma, lymphoblastoid cell lines, and fibroblasts and induced pluripotent stem cells (iPSCs). NIMH-RGR also has candidate gene genotypes, genome-wide association study single nucleotide polymorphism (SNP) panels, and sequence data (whole genome, exome, and RNAseq). The NIMH-RGR is not simply a biobank; it offers a wide array of DNA and RNA analytic services.

The NIMH-RGR supports a large number of researchers, both those who submit biospecimens and data to the Repository as well as those who request access to them. A metric of successful sharing is that NIMH-RGR has a 4.8 ratio of distributions to receipts. Dr. Brzustowicz reviewed NIMH-RGR’s stem cell operations and processing statistics. Researchers are very interested in NIMH-RGR’s stem-cell processing services. In recent years, repository contents have grown and diversified dramatically. NIMH-RGR is adopting new tools needed to manage and navigate the data such as an online access approval system, and emphasizes harmonizing phenotypic data.

Regarding clinical data, most samples are obtained from participants who have one or more DSM diagnoses. An automatic quality control program performs initial checks of phenotypic data integrity and is available to all investigators to help monitor data quality. This helps to reduce typographic errors and collect definitions of any non-standard diagnostic codes. Other clinical data in NIMH-RGR include self-report data, interviewer assessments of behavior, and performance on assessment tasks. Clinical data are derived from a heterogeneous collection of instruments. All participants have an overall diagnosis, but many also have individual item level data available in the repository. There is an opportunity to examine these data in depth with existing samples.

The Diagnostic Interview for Genetic Studies (DIGS) lays the groundwork for studies, but it is a challenge to collate and harmonize the data into a cohesive resource. The schizophrenia, bipolar disorder, and major depressive disorder collections have data from a range of individuals—including relatives of people with the illness who have not shown the condition themselves. However, these individuals may have some related symptoms or behaviors that can be examined using DIGS data. DIGS items can be related to RDoC constructs and can produce dimensional symptom scores, so this dataset presents many opportunities.

The NIMH-RGR is a tremendous resource of biomaterials and detailed clinical data that could be leveraged further. The NIMH-RGR can also add value to biomaterials.  As one example, it can reprogram samples into iPSCs. Although the NIMH-RGR has some limitations (e.g., the data are static and secondary users cannot contact subjects), the resource is very valuable. Dr. Brzustowicz noted that she presents at scientific meetings to promote the resource and encourage more researchers to use it. She acknowledged colleagues and thanked individuals who have participated in studies and investigators who have deposited data.

Discussion

Richard L. Huganir, Ph.D., asked about investigator interactions with the NIMH-RGR. Dr. Brzustowicz responded that scientists directly contact the NIMH-RGR about the specimens and services needed. The NIMH-RGR has a dedicated large communications group that liaises with scientific projects. This group engages in outreach to investigators who are new to the NIMH-RGR to orient them and provide collection kits, training, and prepaid shippers so samples can be tracked. NIMH-RGR has good relationships with depositing scientists. The NIMH-RGR is a controlled-access repository that serves NIH-funded scientists; NIH policies are in effect.

Dr. Robinson Beale asked about the value of collecting samples that are phenotypically classified. There are other sources of psychiatric patient populations in the treatment sector, and phenotypes could be identified in a standard way. Dr. Brzustowicz noted that this is a fundamental debate in the field. The genetics of mental disorders is complex and researchers want to increase the statistical power of studies. To achieve this, researchers can study large samples with reduced clinical data, or smaller samples with a greater depth of clinical data; the issue is not yet resolved. There is a place for large samples, but these need to maintain a good signal to noise ratio. Otherwise, the addition of more samples could actually weaken findings if they add more noise than additional signal. However, many existing samples have not been fully utilized by researchers who need to take advantage of the extant clinical data. Of course, new samples are always welcome and there is the potential for new sources.

Gene E. Robinson, Ph.D., asked whether it was logistically possible to conduct a large RDoC study using only the data already within the repository. Dr. Brzustowicz commented that such a study was possible.

Concept Clearances

Dr. Cuthbert remarked that the purpose of Concept Clearances is to obtain ideas and feedback from the Council to shape potential NIMH initiatives. The Institute will proceed with these initiatives, although the exact timing and publication is not known. Initiatives also depend on funding availability. Concepts are available on the NIMH website, and Council members can submit comments there.

NIMH Biobehavioral Research Awards for Innovative New Scientists (BRAINS) Award

Kathleen Anderson, Ph.D.
Deputy Director, Division of Translational Research

Kathleen Anderson, Ph.D., noted that this Concept Clearance is for a renewal of an existing program. She updated Council on the program a year ago, when three awardees presented their projects and discussed the impact of the awards on their research and careers. The goals of the BRAINS Program have not changed. The BRAINS Program aims to solicit highly innovative, creative, and ambitious research proposals from Early Stage Investigators (ESIs) who have the potential to transform our understanding of the etiology, pathophysiology, treatment of, and service delivery for mental disorders. The program supports promising new investigators early in their careers so they can develop independent, high-risk/high-reward research programs that address the highest priorities for NIMH. Dr. Anderson reviewed the eligibility requirements and noted that BRAINS awards provide 5 years of support, with up to $1.6 million per award in direct costs.

There have been 56 BRAINS awards since 2009, with most in the Division of Translational Research and the Division of Neuroscience and Basic Behavioral Science. Metrics of success tracked by the BRAINS Program include subsequent NIH grant success, publications and the impact of findings. Dr. Anderson noted that over 70% of the earliest awardees have gone onto receive a subsequent NIH grant.  As an example of the impact of BRAINS awards, it was noted that the ketamine findings discussed earlier involved a BRAINS awardee. The expected outcomes of the BRAINS program include an increased number of ESIs supported by NIMH and innovative projects that address all of the NIMH Strategic Objectives. Other expected outcomes are earlier career stability, such as tenure, and significant scientific awards for these promising young investigators. The BRAINS Program continues to expect high-impact research findings that significantly advance the understanding of mental disorders.

NIMH Human Genetics Initiative: Biorepository and Genomics Resource for Psychiatric Genetics

Geetha Senthil, Ph.D.
Office of Genomics Research Coordination

Geetha Senthil, Ph.D., indicated that this Concept continues support for the NIMH-RGR, which Dr. Brzustowicz described in a previous presentation. NIMH is at the forefront of data sharing for biosamples, and clinical and genetic data. The NIMH-RGR is a principal biorepository resource with more than 200,000 well-characterized, high-quality patient and control samples from a wide-range of mental disorders across diverse ethnicities. It distributes more than a million samples to more than 450 external researchers to support approximately 1,500 research projects. The NIMH-RGR is the cornerstone of gene discovery and has contributed to major advancements, as shown by 800 research publications and landmark papers and discovery on bona fide genetic signals.

The objectives for the Biorepository and Genomics Resource for Psychiatric Genetics Concept include sustaining and enhancing the NIMH-RGR using innovative, cost-effective, efficient, and scalable approaches. The resource receives, processes, and characterizes samples; implements quality control; and banks and distributes various types of human-derived biosamples. It generates, characterizes, and distributes renewable resources from various cell types such as IPSC lines. The resource also aims to enhance and maintain capacity for phenotypic and genomic data management using integrated computational workflows and tools. The focus is to curate, standardize, and harmonize clinical/phenotypic data into a uniform structure. For example, these data might be mapped to RDoC dimensions. The resource centrally integrates and manages data associated with biosamples, and links with other public databases and queries, mines, and visualizes data.

Discussion

Regarding the NIMH-RGR, Christopher A. Walsh, M.D., commented that he has both contributed to and used this resource, which is amazing and visionary. Most researchers gain more from this resource than they contribute.

Transdisciplinary Research Centers to Advance Clinical Practice in Mental Health

Robert Heinssen, Ph.D., ABPP
Director, Division of Services and Interventions Research

Robert Heinssen, Ph.D., ABPP, noted that this is a new Concept. The general idea is to apply lessons learned from RAISE and combine them with exciting developments. NIH emphasizes rapid transfer of findings from clinical studies to community practice settings. It recognizes that deployment-focused intervention development and stakeholder involvement can speed translation. The digital revolution is driving innovation in health care broadly and is transforming translational research. Translational Research Centers can facilitate eclectic teams and nimble research for improving mental health outcomes.  

This Concept focuses on optimizing the clinical impact of validated treatments, aligned with several NIMH Strategic Objectives as outlined in the NIMH Strategic Plan for Research. Phase 2 (T2) Translational Research Centers will comprise transdisciplinary teams of clinical and social scientists, information and communication technologists, systems engineers, and mental health service users. They will serve as an incubation space for developing novel and convergent solutions for personalized, recovery-oriented treatment. These Centers will engage in rapid testing, implementation, and refinement of integrative approaches in real-world environments. They will conduct research that improves practice and clinical outcomes for children, youth, and adults (including older adults) with mental illness.

Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers will have several expected outcomes. Their data, methods, and resources will promote near-term improvements in clinical practice. They will serve as models projecting public health impact for optimized interventions and services. ALACRITY Research Centers will forge new research directions that arise from interdisciplinary collaboration. They will offer formative phase 2 translational research for junior investigators and trainees.

Discussion

Dr. Hogan remarked that the proposed ALACRITY Research Centers represent a thoughtful response to issues discussed by the Council. This Concept is a good example of striking a balance between investments that make a difference to mental health in the short-term and those that influence the long-term outlook. It presents a great opportunity for translation. He also mentioned that Council may want to discuss an editorial on this topic, which will be published in the June issue of the British Journal of Psychiatry. Dr. Linehan also supported the Concept, commenting that it represented a new and more persuasive way to get evidence-based treatments into the community. Dr. Robinson Beale suggested combining this Concept with the training of psychiatrists in neuroscience. Dr. Areán also supported the Concept and agreed that it should incorporate team science and education. Dr. Cuthbert noted the convergence of ideas among various NIMH initiatives. He highlighted the importance of programs that enable the incorporation of neuroscience into front-line practice. Dr. Linehan pointed out the perceived barriers to adopting new treatments among clinicians. The innovative aspect of the ALACRITY Research Centers Concept is the incorporation of social science and evaluation so clinicians want to adopt new treatments.

Personalized Mental Health Navigator for Children and Adolescents

Denise Pintello, Ph.D.
Division of Services and Interventions Research

Denise Pintello, Ph.D., noted that NIMH would like to test a Personalized Mental Health Navigator model to promote early engagement, linkage and coordination of mental health treatment and services for children and adolescents who are identified with early onset mental illness symptoms, or are at high risk for developing mental illnesses. Nearly 50 percent of children with mental health problems do not receive the treatment they need. Subclinical symptoms are more likely to develop into serious problems, so early intervention and coordination of services is essential.

A navigator is a health care provider assigned to work with youth and families to obtain needed treatment and services. To date, several variations on the use and type of navigators across related health care fields have been tested. For example, SAMHSA and the Health Resources and Services Administration are testing a peer navigator for adults with SMI. The Personalized Mental Health Navigator would work with youth and families immediately after symptom identification (early intervention) and employ behavioral strategies (e.g., motivational interviewing). The Navigator would also facilitate and monitor communication and linkages (coordination of services) with clinicians, youth, and families and utilize technologies to track symptoms and match patients to the needed treatment intensity, frequency, and dosage.

Under this Initiative, NIMH would invite research applications that develop and test care coordination strategies and technologies to help identify, engage, and match youth in treatment and services to the required dosage, intensity, and frequency. Applications should identify mediators/mechanisms to detect the active components of treatment and match to the most relevant therapies and services. The expected outcomes of the Initiative are to develop a set of research-informed strategies designed to improve care coordination and match youth to appropriate treatment and services. NIMH also expects to develop an initial body of generalizable knowledge regarding effective mental health navigation models and the impact on health disparities among underserved populations. NIMH sees this Initiative as a concrete step toward addressing the NIMH Strategic Objective 4.3: Develop innovative service delivery models to improve dramatically the outcomes of mental health services received in diverse communities and populations.

Discussion

Dr. Barch commented that the Personalized Mental Health Navigator is a great idea. However, she pointed out that many communities do not have enough treatment resources for youth and families. If the treatment resources are not there, then the Navigator may be set up for failure. Dr. Pintello responded that NIMH will engage stakeholders to identify resources. Dr. Robinson Beale agreed with Dr. Barch, and added that the scope of evidence-based treatments for youth and adolescents is not settled. That is, a wide array of interventions is available, but it is not clear which are most effective. Dr. Linehan noted that there are long waitlists for treatment; therefore, it is necessary to increase the number of practitioners who can deliver these treatments. Treatment centers do not have funding to train staff members. Dr. Brent agreed with others’ comments. There are many evidence-based treatments in child mental health and the lack of clinicians to deliver them is the problem. Mary Jane Rotheram, Ph.D., added that children with SMI or multiple problem behaviors, and their families, need more intensive and a wider range of services. These families require “one-stop shopping” for services, but it seems that funds are not available for this. Dr. Areán agreed and suggested that the initiative might examine system-level issues for children and how technology can extend the reach of providers of evidence-based care.

Research to Support the Investigation and Elimination of Health Disparities

Charlene Le Fauve, Ph.D.
Deputy Director, Office for Research on Disparities and Global Mental Health

Charlene Le Fauve, Ph.D., noted that the Nation is diversifying, and there is a need to address mental health disparities. A recent article in The Atlantic, for example, discusses the lack of autism research with members of diverse populations. Research indicates that racial and ethnic minorities generally have lower prevalence of mental disorders with the exception of American Indians and Alaskan Natives, and individuals of two or more races.  For minorities who do have mental disorders, the course of illness is more severe and persistent than in majority populations. Among individuals who have a mental illness in the past year, Asian and Black people underuse mental health services as compared to White people. NIMH’s Mental Health Disparities Program addresses these issues. The goals of the Program are to foster research across NIMH Strategic Objectives through the recruitment and study of diverse racial and ethnic groups. The Program aims to increase the understanding of mechanisms underlying disparities and differences in mental health status, scale up evidence-based interventions to reduce disparities, and reduce disparities in access to, quality of, and outcomes of care.

This initiative aims to support additional recruitment, data collection, and/or analyses across diverse groups relevant to studies that identify early biological and environmental risk and protective factors associated with mental health status to serve as potential targets for intervention. It would also support studies that test community engagement, adherence, and retention strategies designed for diverse populations, and those that apply unbiased genomic approaches to assess genetic risk contribution to mental illnesses. The Initiative would also support research that aims to understand reasons for disparities in suicide burden and potential contributors to suicide risk and protective factors.

Discussion

Hyong Un, M.D., commented that research to support the reduction and elimination of mental health disparities should include work on treatment retention. Dr. Areán agreed and noted the importance of developing treatments that people can continue to participate in is important for minorities (e.g., they may not be able to visit an office on a weekly basis). Dr. Hogan commented that perhaps research in this area could include health plans as collaborators. Proactive plans are trying to meet the needs of their members, and perhaps incorporating this in a controlled way could be part of the research. Dr. Druss stressed the need to encourage researchers to use existing data to identify the problem.

National NeuroAIDS Tissue Consortium

Dianne Rausch, Ph.D.
Director, Division of AIDS Research

Dianne Rausch, Ph.D., noted that this Concept aims to support the continuation of the National NeuroAIDS Tissue Consortium (NNTC). The NNTC maintains a research resource that supports studies on the pathogenesis of HIV-associated neurological dysfunction in the context of anti-retroviral therapy (ART).  Two types of continuation applications would be solicited through a limited competition: 1) applications to support the clinical assessments and banking of HIV-positive brain tissues and fluids at the NNTC Clinical Sites; and 2) applications to support the associated database center referred to as the Data Coordinating Center (DCC).  The NNTC Clinical Sites work cooperatively with the DCC to provide clinical data and specimen resources to research investigators. A limited competition is necessary to preserve the banking resource, including the accumulated biospecimens, and to ensure that ongoing collection of specimens will be uninterrupted. It is anticipated that the NNTC would continue to expand the existing multi-site brain bank structure of the NNTC to incorporate distribution of resources located at national and international sites into the cohort-based functions of the consortium.

HIV-associated neurological dysfunction continues in the era of anti-retroviral therapy.  The NNTC was first established in 1998 as a unique resource for NeuroAIDS investigators interested in conducting research on HIV-associated dysfunction of the central and peripheral nervous system (CNS and PNS).  The NNTC cohort is comprised of late stage HIV-positive participants willing to participate in organ donation, most of whom use anti-retroviral therapy.  Comprehensive neuromedical, neuropsychological, psychiatric and virological data are collected ante mortem, samples collected post mortem are clinically annotated, and the associated research data sets are maintained in the repository. The NNTC also includes fluid, clinical and associated data from the multi-site observational study, CNS HIV Antiretroviral Therapy Effects Research (CHARTER), which explored the changing presentation and persistence of HIV neurological complications in the context of ART from 2002-2015. The NNTC collection contains clinical data from over 4,700 individuals, including approximately 1,042 brains, thousands of plasma and cerebrospinal fluid samples, and additional organs and nerves of interest.  To date, the NNTC has resulted in 804 scientific publications.  This research resource ensures that the collection remains accessible to the scientific community.

The NNTC Clinical Sites are responsible for the following: 1) recruitment, clinical assessment and follow-up of the late-stage NNTC cohort; and 2) collection, maintenance and distribution of sample resources.  The DCC works with the NNTC Clinical Sites to provide 1) management and database capabilities to ensure effective clinical and brain banking operations, and to serve as the data repository for the NNTC; 2) scientific expertise in biostatistics and HIV epidemiology to enable broad analysis of the NNTC clinical database; and 3) expansion capability to include distribution of specimens and data stored at other national and international sites to ensure that scientific investigators have access to central and peripheral nervous system specimens that are difficult to obtain from HIV-infected individuals across the lifespan.

This initiative aims to continue funding the NNTC as a critical resource for catalyzing high priority research in NeuroAIDS, including studies to understand the mechanisms of HIV neuropathogenesis, aging with long-term HIV disease and ART, and research towards a cure for HIV infection of the CNS.

Discussion

Regarding the NNTC, Dr. Krystal wondered about the quality of clinical phenotyping among subjects with comorbid substance use and mental health disorders. Comorbidity might influence immune system functioning. Dr. Rausch responded that the phenotyping is significant and involves clinical psychologists and strong screening for substance abuse. Neurologists and psychiatrists also participate in the team evaluation. The NNTC uses diagnostic scales and quality assurance on various assessments to ensure they are consistent.

Public Comment

Dr. Cuthbert invited members of the audience to make any comments to the Council.

Michael Byer, President and Co-Founder of M3 Information, spoke about primary care, the first line of defense for mental health. Mr. Byer pointed out that most of the work discussed would not be funded by CMS under the Medicare Access & CHIP Reauthorization Act of 2015. Many of the current quality measures focus on depression, but other disorders are important and necessary to consider. Regarding leveraging current knowledge on treatment, there are multiple dimensions to mental health. Mental illnesses are the only chronic conditions that do not have a number or a score to convey severity or complexity. However, research has shown a predictive score for mental health. A company has developed a mental health assessment panel (examining more than depression) that can be ordered by any doctor. A score is provided with healthy ranges.

Tanya Shuy expressed her hope that gaming would be used as an intervention for mental health disorders. She agreed that there is a gap between evidence and service delivery. People are not receiving evidence-based care, especially young adults. Reflecting on her daughter’s suicide, she noted the need for greater prevention efforts. The ketamine research mentioned earlier is promising; NIMH should continue to support it and work with the FDA to expedite treatment development. Technology can expand the delivery of evidence-based treatment, and data from personal devices such as smart phones and fitness trackers may be particularly useful. The ALACRITY Research Centers Concept also seems promising, and she thanked the Council for highlighting important lessons and work that needs to be done.

Dr. Cuthbert thanked members of the public for their remarks.

Hearing no further comments from the public, Dr. Cuthbert adjourned the meeting at 1:25 p.m.

Appendix A

Summary of Primary MH Applications Reviewed

Council: May 2016

Category	IRG Recommendation
	Scored #	Scored Direct Cost $	Not Scored (NRFC) #	Not Scored (NRFC) Direct Cost $	Other #	Other Direct Cost $	Total #	Total Direct Cost $
Research	555	$711,410,876.00	402	$423,097,362.00	8	$13,011,270.00	965	$1,147,519,508.00
Research Training	0	$0.00	0	$0.00	0	$0.00	0	$0.00
Career	57	$39,370,536.00	31	$22,883,594.00	0	$0.00	88	$62,254,130.00
Other	0	$0.00	0	$0.00	0	$0.00	1	$0.00
Totals	612	$750,781,412.00	433	$445,980,956.00	8	$13,011,270.00	1053	$1,209,773,638.00

Appendix B

Department of Health and Human Services
National Institutes of Health
National Institute of Mental Health
National Advisory Mental Health Council

(Terms end 9/30 of designated year)

Chairperson

• Bruce N. Cuthbert, Ph.D.
  Acting 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

• Patricia A. Areán, Ph.D. (16)
  Professor
  Director of Targeted Treatment Development
  University of Washington
  Department of Psychiatry and Behavioral Sciences
  Seattle, WA

• Deanna M. Barch, Ph.D. (16)
  Gregory B. Couch Professor of Psychiatry
  Department of Psychology, Psychiatry and Radiology
  Washington University
  St. Louis, MO

• David A. Brent, M.D. (17)
  Academic Chief
  Child & Adolescent Psychiatry
  Endowed Chair in Suicide Studies
  Professor of Psychiatry, Pediatrics and Epidemiology
  Director, Services for Teens at Risk
  University of Pittsburgh School of Medicine
  Pittsburgh, PA

• BJ Casey, Ph.D. (16)
  Sackler Professor
  Department of Psychiatry and Neuroscience
  Sackler Institute for Developmental Psychobiology
  Weill Medical College of Cornell University
  New York, NY

• Benjamin G. Druss, M.D., M.P.H. (18)
  Rosalynn Carter Chair in Mental Health and Professor
  Department of Health Policy and Management
  Rollins School of Public Health
  Emory University
  Atlanta, GA

• Hakon Heimer, M.S. (16)
  Founding Editor
  Schizophrenia Research Forum
  Brain and Behavior Research Foundation
  Providence, RI

• Michael F. Hogan, Ph.D. (18)
  Consultant and Advisor
  Hogan Health Solutions LLC
  Delmar, NY

• Richard L. Huganir, Ph.D. (17)
  Professor and Director
  Department of Neuroscience
  Investigator, Howard Hughes Medical Institute
  Co-Director, Brain Science Institute
  The Johns Hopkins University School of Medicine
  Baltimore, MD

• John H. Krystal, M.D. (19)
  Robert L. McNeil, Jr. Professor of Translational Research
  Chair, Professor of Neurobiology
  Chief of Psychiatry, Yale-New Haven Hospital
  Department of Psychiatry
  Yale University School of Medicine
  New Haven, CT

• Marsha M. Linehan, Ph.D. (17)
  Professor and Director
  Behavioral Research and Therapy Clinics
  Department of Psychology
  University of Washington
  Seattle, WA

• Maria A. Oquendo, M.D. (17)
  Vice Chair for Education
  Professor of Psychiatry
  Department of Psychiatry
  Columbia University
  New York State Psychiatric Institute
  New York, NY

• Gene E. Robinson, Ph.D. (16)
  Director, Institute for Genomic Biology
  Swanlund Chair
  Center for Advanced Study Professor in Entomology And Neuroscience
  University of Illinois at Urbana-Champaign
  Urbana, IL

• Rhonda Robinson Beale, M.D. (19)
  Senior Vice President and Chief Medical Officer
  Blue Cross of Idaho
  Meridian, ID

• Mary Jane Rotheram, Ph.D. (16)
  Bat-Yaacov Professor of Child Psychiatry And Behavioral Sciences
  Director, Global Center for Children and Families
  Director, Center for HIV Identification Prevention And Treatment Services (CHIPTS)
  Semel Institute and the Department of Psychiatry, University of California, Los Angeles
  Los Angeles, CA

• J. David Sweatt, Ph.D. (16)
  Professor
  Evelyn F. McKnight Endowed Chair
  Department of Neurobiology
  Director, McKnight Brain Institute
  University of Alabama at Birmingham
  Birmingham, AL

• Hyong Un, M.D. (17)
  Head of EAP & Chief Psychiatric Officer
  AETNA
  Blue Bell, PA

• Christopher A. Walsh, M.D. (19)
  Chief, Division of Genetics and Genomics
  Boston Children’s Hospital
  Bullard Professor of Pediatrics and Neurology
  Harvard Medical School
  Boston, MA

Ex Officio Members

Office of the Secretary, DHHS

• Sylvia M. Burwell
  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

• Theresa Gleason, Ph.D.
  Deputy, Chief Research & Development Officer
  Office of Research & Development
  Department of Veterans Affairs
  Washington DC

Department of Defense

• John W. Davison, M.B.A., Ph.D.
  Chief, Conditioned-Based Specialty Care Section
  Clinical Support Division
  Defense Health Agency
  Department of Defense
  Office of the Chief Medical Officer (OCMO)
  TRICARE Management Activity, OASD (HA)
  Falls Church, VA

Liaison Representative

• Paolo del Vecchio, M.S.W.
  Director
  Center for Mental Health Services
  Rockville, MD