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2020 NIMH Joint Alliance-Coalition for Research Progress Town Hall

Date/Time:

Welcome and Introductions

Joshua A. Gordon, M.D., Ph.D., Director, NIMH
Meredith A. Fox, Ph.D., Director, Office of Science Policy, Planning, and Communications, NIMH

On October 5, 2020, the National Institute of Mental Health (NIMH) held a virtual Town Hall to bring together the NIMH Alliance for Research Progress and the NIMH Professional Coalition for Research Progress. Dr. Joshua Gordon, Director of NIMH, explained that the Institute recently examined its communication and stakeholder engagement strategies and, accordingly, deployed a new outreach approach that increases public access to information about mental health research and facilitates communication between NIMH, professional societies, and advocacy groups. This virtual Town Hall meeting represented a step towards this goal.

Dr. Meredith Fox, Director of NIMH’s Office of Science, Policy, Planning, and Communications (OSPPC), was excited to announce that this meeting was the first event in recent years in which NIMH brought together both the Alliance for Research Progress (or Alliance) and the Professional Coalition for Research Progress (or Coalition) to discuss mental health research priorities at NIMH. The Alliance comprises national organizations focused on family and patient advocates, while the Coalition comprises national professional societies. During this Town Hall, NIMH aimed to communicate mental health research to the public, share research findings, and strengthen partnerships to advance the missions of the Alliance, the Coalition, and the NIMH.

The Town Hall consisted of three presentations from National Institutes of Health (NIH) staff who spoke about ongoing mental health research initiatives, a brief discussion panel with these presenters, and an hour-long question-and-answer session with Dr. Gordon. Highlights from the meeting are summarized below.

NIH and NIMH Research Initiatives

All of Us Research Program Programmatic Update: A Glimpse of Mental Health Data in All of Us
Holly Garriock, Ph.D., Acting Director, Division of Scientific Programs for the All of Us Research Program, NIH
Presentation slides (HTML | PDF)

Dr. Holly Garriock is the Acting Director of the Division for Scientific Programs for the All of Us Research Program at the NIH. All of Us is an NIH-wide initiative that aims to enroll one million or more participants who reflect the broad diversity of the U.S. population. Participants partner with the program for 10 or more years and agree to donate their electronic health records (EHRs) and various biospecimens (including blood and DNA samples), and to complete health surveys.

Thus far, the All of Us Program has engaged more than 271,000 participants who have begun the initial steps of the protocol. The program prioritizes diversity and representation, 80% of participants are members of groups that have been historically underrepresented in biomedical research, including racial and ethnic minority groups, lower socioeconomic strata, and lower education levels.

Like many other clinical research programs, All of Us paused its enrollment activities in March 2020 at the beginning of the COVID-19 pandemic and began to refocus efforts on digital enrollment and retention. Some All of Us clinics were reactivated as of mid-July 2020. Researchers at All of Us have found that digital engagement increases significantly each time the program releases a new survey; therefore, they have released a new survey each month to stimulate online activity.

In May 2020, the program released the COVID-19 Participant Experience (COPE) Survey, which asks questions about personal and family medical history related to mental health including anxiety, depression, stress, physical activity, and suicidal thoughts and behavior. More than 30% of respondents indicated experiencing severe mental health conditions from May to July of the COVID-19 pandemic, and 7% met criteria to receive an automated suicide prevention pop-up message. While the COPE survey does not include a component for eating disorders, the soon to be launched mental health and wellbeing survey does.

Additionally, All of Us is leveraging its large bank of biospecimens to conduct serum sample antibody testing using EHR information from the more than 4,000 participants who have been tested for COVID-19. The program is working to standardize EHR information on COVID-19 symptoms, associated health problems, and effects of different treatments and medicines. All of Us also collaborates with the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program.

Going forward, All of Us will launch survey questions for mental health and wellbeing, as well as a mood module. The program is also preparing to launch a virtual mental health campaign that includes an ecological momentary assessment, communications resources, and mental health awareness and education materials.

NIH BRAIN® Initiative: Future Directions
John Ngai, Ph.D., Director, Brain Research through Advancing Innovative Neurotechnologies (BRAIN®) Initiative, NIH
Presentation slides (HTML | PDF)

Dr. John Ngai is the Director of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, which was developed to revolutionize understanding of the human brain by accelerating the development and application of innovative technologies. The BRAIN Initiative represents a partnership between five U.S. agencies and several private foundations.

The BRAIN Initiative supports the development and application of new tools to understand how neural circuits contribute to complex behaviors in healthy and diseased brains. Three areas of activities are intended to facilitate this goal. First, NIH needs to leverage existing technology and new technological innovations to enable discoveries about neural circuit function. Second, these discoveries must form a foundation for new therapeutic strategies for human brain disorders. Third, NIH must focus on making these technologies for basic discovery and clinical applications more widely accessible and usable.

The BRAIN 2025 Report is the original plan for achieving the goals of the BRAIN Initiative. In 2018, the NIH Advisory Committee to the Director convened the BRAIN Working Group 2.0 to assess the progress and context of the BRAIN 2025 Report, and to make recommendations for the next phase of the initiative. The Working Group recommended that the BRAIN Initiative balance individual-investigator research with team science and devote ample resources to large-scale transformative projects.

The BRAIN Initiative’s funding history reflects the program’s rapid development. In 2014, NIH’s initial investment in the BRAIN Initiative was approximately $46 million. By fiscal year 2020, funding increased to approximately $500 million, matching the recommended funding goal in the BRAIN 2025 Report. The BRAIN Initiative has supported more than 700 awards resulting in 900 publications to date. Funding is expected to increase substantially in fiscal year 2023 as a result of the 21st Century Cures Act, at which time the BRAIN Initiative will begin to pursue three larger-scale transformative projects. The first of these is to construct a human brain cell atlas (parts list), which will build on the success of the BRAIN Initiative Cell Census Network (BICCN) – the mouse brain cell census – to advance towards human brain cell mapping. The second large project, the microconnectivity analysis, will aim to develop technologies to diagram the wiring system of the human brain. Finally, the third large project, the cell type-specific armamentarium, will organize resources for brain cell type-specific identification, activity monitoring, and manipulation, and the project will ultimately extend to human cells and tissues. The first Request for Applications (RFA-MH-20-556) for the armamentarium was issued in September 2020.

The discoveries supported by the BRAIN Initiative, such as closed-loop deep brain stimulation devices and targeted molecular and gene therapies, lay the foundation for novel interventions in human brain disorders. All the BRAIN Initiative’s efforts are intended to help humans, and the immense ethical implications of this work are carefully considered. The BRAIN Initiative’s standing Neuroethics Working Group examines these ethical implications on an ongoing basis, and the Working Group’s guiding principles include safety, privacy, agency, and public engagement.

NIMH Intramural Research Program Response to COVID-19
Maryland Pao, M.D., Clinical Director and Deputy Scientific Director, Intramural Research Program, NIMH
Presentation slides (HTML | PDF)

Dr. Maryland Pao is the Clinical Director and Deputy Scientific Director of the Intramural Research Program (IRP) at NIMH.  The IRP is NIMH’s internal research division, which plans and conducts basic, clinical, and translational research to advance understanding of the diagnosis, causes, treatment, and prevention of psychiatric disorders.

In response to the COVID-19 pandemic, the NIMH IRP amended three existing studies with youth participants to incorporate COVID-19 data collection: one on adolescent depression, one on severe mood and behavior dysregulation in children, and one on the effects of the antidepressant drug fluoxetine on attention and emotional memory in youth and adults with depression and anxiety.

Additionally, IRP investigators developed new studies to measure the mental health impact of COVID-19 on NIMH research participants and volunteers, on health care workers, and on anxiety and motivation in the general public. One of these new studies involves the Coronavirus Health Impact Survey (CRISIS) 3.0, a collaborative effort that has been translated into 10 different languages internationally. The survey is available online, and several thousand surveys have already been completed.

The IRP has access to a large bank of baseline pre-COVID data, which they are now using to try to understand the impact of COVID-19 on mental health. Investigators continue to add to this dataset by administering questionnaires, conducting experimental tasks, and providing clinical care and therapy via telehealth services. Preliminary results from 106 adolescents with depression and 70 healthy volunteers suggest that the COVID-19 pandemic has not caused an overall increase in depressive symptoms in this group, although individuals’ responses were highly variable over time. These preliminary results indicate that the relationship between depression and the pandemic is complex and must be considered carefully.

The IRP is also collaborating with the National Institute of Allergy and Infectious Disease (NIAID) on a longitudinal study of COVID-19 survivors. This study is following up with 300 survivors and close contacts at six-month intervals. NIMH IRP investigators are studying a subsample of this population to determine the mental health impact of COVID-19 over the next three years.

In response to COVID-19, IRP investigators also modified the Ask Suicide-Screening Questions (ASQ) tool, a suicide screening tool for hospitals to measure suicide risk. The updates amend the protocol to provide alternatives to referral to the emergency department when there is fear of spreading or contracting COVID-19. The ASQ now includes a universal pathway and an enhanced safety planning component.

Questions and Answers with the NIMH Director

Joshua A. Gordon, M.D., Ph.D., Director, NIMH

Question: How is NIMH responding to criticism of the use of animals in research?

Answer: There is an active community of advocates who are concerned about the welfare of animals used in research, and an extensive community of researchers who are equally concerned and want to ensure that all of the work at NIMH and across the country continues to be conducted ethically and prioritizes the welfare of animal subjects. It is important that the public understand that basic science provides a foundation for the field of clinical science and mental health care—and that this knowledge directly enables better treatments for mental illnesses. To this end, NIMH has engaged in a number of efforts, including an NIMH Director’s Message, press releases, and other public outreach activities, to communicate the importance of animal research and share a reminder that all NIMH animal research is conducted ethically and appropriately.

Question: In terms of clinical research, it is expensive and time-consuming to set up networks of mental health service providers to conduct clinical trials. What are the advantages and disadvantages of supporting a network of providers to stand up clinical trial protocols quickly?

Answer: NIMH transitioned from this clinically driven model to an experimental therapeutics model, in which all clinical trials are required to ask and answer specific hypotheses about the mechanisms of actions of the treatments they study. These requirements ensure that the work is important, generalizable, and advances the field of mental health treatment. Clinical research studies are most successful when teams are assembled to specifically tackle a question, rather than relying on pre-existing teams and networks that may not be best equipped to address certain research questions. Additionally, pre-existing networks tend to remain in place long after they have achieved their original goals, which has implications for NIMH resources.

Question: How will the NIH address co-morbidity, specifically in terms of mental disorders that are inextricably mixed with physical disorders?

Answer: NIMH has addressed this issue through landmark implementation research findings such as the importance of collaborative care models and coordinated specialty care for mental illnesses and comorbid disorders. Conducting research at the boundaries of multiple NIH Institutes poses a challenge, but NIMH has worked to forge relationships that facilitate these partnerships. For example, NIMH researchers have supported efforts to understand obesity and metabolic disorders in the context of psychosis and other psychiatric illnesses by listening to stakeholders’ priorities and concerns. NIMH is working with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and other Institutes to ensure that they are aware of mental health comorbidities among their populations of interest.  

Question: Can you provide an update on the Accelerating Medicines Partnership (AMP) for schizophrenia (SCZ) initiative?

Answer: AMP is an NIH-wide program run by the Foundation for the National Institutes of Health (FNIH). Its purpose is to enable public-private partnerships so that NIH Institutes can work with pharmaceutical companies, private foundations, and other non-governmental organizations to achieve common aims in research. The AMP SCZ program officially launched in September 2020. AMP SCZ research projects involve networks of community-based research clinics that will recruit individuals in late adolescence at high risk for psychosis, as well as some individuals who already have early psychosis, to identify biomarkers based on recent NIMH-supported schizophrenia research. These biomarkers will advance our understanding of the neurobiological mechanisms underlying psychosis, which will inform the development of clinically effective drugs for these patients. AMP SCZ is unique in that it prioritizes community-based clinics, and it aims to develop an international cohort of thousands of individuals at risk for psychosis.

Question: As NIMH is ramping up for fiscal year 2021 research grants, how will you determine how much funding goes to each disorder?

Answer: It is important to know that NIMH does not allocate a specific dollar amount to each mental illness. Instead, funding is determined by the quality, number, and cost of applications. Applications are reviewed by an independent peer review panel that scores each application, and NIMH staff review these scores for alignment with program priorities. NIMH regularly evaluates its portfolio to determine areas with opportunities for growth and encourages scientists to fill these gaps. All NIMH applications considered for funding are vetted publicly by the National Advisory Mental Health Council (NAMHC).

Question: What priority does NIMH give to funding clinical treatment studies?

Answer: First and foremost, NIMH assesses the quality of applications to guide funding decisions. Funded research exists on a continuum but can be divided roughly into three segments: research with short-term, medium-term, and long-term payoffs. Short-term includes clinical studies that address patients’ needs, medium-term includes translational research, and long-term includes work that advances our fundamental understanding of the brain. NIMH aims to maintain a balance of these three areas.

Question: How is NIMH responding to COVID-19?

Answer: The COVID-19 response at NIMH has two facets. The first is internally focused on the NIMH workforce to ensure that NIMH scientists who work in IRP laboratories and the Clinical Center remain safe and supported during this crisis. Upon return-to-work, we are equipping scientists with Centers for Disease Control and Prevention (CDC)-recommended personal protective equipment, implementing physical distancing, and launching a voluntary employee COVID-19 testing program. NIMH also provides its employees with the resources and support they need to cope with the psychological effects of the pandemic.

The second facet addresses the extramural research community. NIMH recognizes that more research is needed to understand and reduce the mental health impacts of the pandemic, and that NIMH-funded scientists need support to continue their work during this time. NIH has launched a COVID-19 research program and so far has funded $250 million worth of grants in this area, most of which come from special allocations to invest in testing for underserved communities and in understanding, measuring, and mitigating the mental health impacts of the crisis.

Question: Does NIMH have a recommendation for emergency medical technician (EMT) use of ketamine in pre-hospital emergency situations involving people with serious mental illness?

Answer: NIMH does not make treatment recommendations. There is no known clinical justification for use of ketamine as a sedative by EMTs, and this is not a Food and Drug Administration (FDA)-approved use for ketamine. Currently, NIMH is engaged in other ketamine-related research, such as the utility of ketamine in emergency rooms for acutely suicidal patients. 

Question: How is NIMH addressing the mental health effects of racism?

Answer: These efforts are a work in progress. In the past, NIMH has supported research about the effects of trauma and discrimination more generally, and to a certain extent, the effects of racial discrimination on mental health. Much of this research has focused on the developmental effects of this mistreatment, and much of it relies on the existing literature for more generalized stress paradigms.

Last year, NIMH participated in the American College of Pharmacology Meeting, during which there was a morning-long symposium that combined basic science of stress biology with clinical research on the effects of discrimination on mental health. NIMH looks forward to advancing these efforts in the years to come.

Question: NIH requires that any general article reporting on federally funded research be made freely available within a year. What is NIMH doing about this issue?

Answer: This is an issue discussed not only within NIH but at all levels of government. When it was first implemented, the one-year publication policy was seen as a compromise. There is interest in requiring all publications to be open access from journal acceptance. The Howard Hughes Medical Institute (HHMI), a large private funder of biomedical research, has just announced that all research articles with major contributions from an HHMI laboratory will be open-access immediately upon publication.

Question: What is NIMH’s involvement in the Helping End Addiction Long-term (HEAL) Initiative?

Answer: The Helping to End Addiction Long-termSM Initiative, or NIH HEAL Initiative, is an NIH-wide initiative launched in 2018 to address the epidemic of opioid overdose and misuse in the United States. This is a multi-Institute effort, and funding comes from a specific Congressional allocation rather than any Institute’s primary allocations. NIMH plays an important role in the NIH HEAL Initiative. Its major contribution is at the intersection of substance use disorders, pain, and mental illnesses, which are interrelated both mechanistically and clinically. As part of this, NIMH launched an effort to examine the role of collaborative care models to improve treatment for individuals with comorbid mental health and opioid use disorders in primary care settings, with a focus on under-resourced and rural areas.

Question: What is NIMH planning in terms of the research domain criteria (RDoC) framework, and what can the research community expect from RDoC in the future?

Answer: The RDoC framework, which was developed ten years ago, is an attempt to break down behavior into its component structure and use that structure to understand the mechanisms underlying mental illnesses. Recently, RDoC started to incorporate biomarkers, which is made possible by the frameworks’ transdiagnostic, dimensional approach to understanding behavior. Going forward, NIMH is working on two goals: developing a more data-driven approach to RDoC, and describing behaviors with a focus on mathematical formalization. RDoC has been adopted widely throughout the world as a useful conceptual model for understanding neurobiological function and dysfunction in people with mental illnesses.  

Question: What has NIMH learned from the Autism Biomarkers Consortium for Clinical Trials (ABC-CT)?

Answer: The ABC-CT project is a public-private partnership supported by FNIH and funded by multiple NIH Institutes. The ABC-CT project seeks to develop biomarkers that will help to identify individuals with autism spectrum disorder (ASD) earlier in the lifespan or with greater fidelity than current diagnostics, as well as to assess clinical response to ASD treatments. To date, ABC-CT-supported researchers have identified at least two promising biomarkers that are advancing through the biomarker qualification process with the FDA. If approved by the FDA for inclusion in clinical trials, these biomarkers may facilitate and speed up clinical trials for ASD treatments and increase confidence in medications and other therapies for patients with ASD. The ABC-CT has received strong interest from the pharmaceutical industry, which hopes to include these biomarkers in their own clinical trials.

Question: What is NIMH doing to address the alarming rates of suicide among Black youth?

Answer: NIMH recently released a Director’s Message on this topic. Suicide prevention remains a top priority at NIMH, especially given the elevated and increasing rates of suicide in the United States. One of the more disturbing aspects of these trends is that suicide rates are increasing rapidly among young people, and especially among Black youth. To address this alarming trend, NIMH has funded several studies among Black youth to understand issues related to access to and engagement with mental health care. NIMH will continue to call for research on youth suicide, and recently released a Notice encouraging research focused on addressing suicide among Black youth.

Question: What is NIMH doing to support interventions and services for people living with eating disorders?

Answer: NIMH hopes to see more applications and work in this area in the coming years. One example of a project NIMH currently supports employs a contemporary approach using social media to reach teenagers who have eating disorders. The researchers are testing the effectiveness of a mobile app specifically designed to reduce the symptoms of eating disorders and improve quality of life. A related project aims to leverage social media to deliver body-positive recovery message and to identify and connect with at-risk individuals to refer them to supports and services.

Question: How will the new NIMH Strategic Plan for Research be updated with findings as the year goes on?

Answer: NIMH recently finished an update to its Strategic Plan, which is revised every five years. When NIMH-funded research results in exciting findings or advances, NIMH shares this through press releases, research highlights, and other messaging, and will now link these messages to the Strategic Plan. This live updating strategy provides the research community and the public with up-to-date public knowledge about treatment and prevention efforts related to mental illnesses. This is one way we ensure the Strategic Plan stays current and relevant, and that it accurately reflects scientific progress over the next five years.

Question: In addition to biomarkers, what are the areas within autism research that offer special promise or demand particular attention?

Answer: The Interagency Autism Coordinating Committee (IACC) has provided valuable guidance on developing research in high-demand areas. One priority area in recent years at NIMH has been to support science that leads to interventions targeted for adults and transition-age youth with ASD. Another is to address prevention and intervention strategies to help families who experience morbidity and mortality as a result of violent or aggressive behavior from a loved one with ASD. In translational research, NIMH is excited to explore novel ways to leverage knowledge about the genetics of ASD. Scientists have identified nearly 100 different genes that confer risk for ASD, and they are working hard to understand how these mechanisms may raise risk for ASD and may be appropriate targets for exploring treatments.