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Alliance for Research Progress - October 14, 2014 Meeting


Location: Rockville, MD


NIMH Alliance for Research Progress Fall Meeting
This overview describes the twenty-first meeting of the National Institute of Mental Health’s (NIMH) Alliance for Research Progress (Alliance) on Tuesday, October 14, 2014, in Rockville, Maryland. At Alliance meetings, participants hear about research advances, projects, and activities at the National Institutes of Health (NIH) and NIMH. The meetings also provide an opportunity for Alliance members to network with colleagues in person and to interact directly with NIMH director, Thomas Insel, M.D., and senior NIMH staff. Participants include leaders from national mental health-related organizations representing patients and their families. The October meeting included presentations and discussions about the NIMH Strategic Plan; the Mood Patient-Powered Research Network—the Patient-Centered Outcomes Research Institute (PCORI) effort most relevant to mental health; and the use of mobile data and behavioral analytics to improve health outcomes; and the Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS), a study focusing on mental health resilience and suicide risk among military personnel. For more information on the speakers, please see the attached agenda and participant list.

Major Themes

Welcome and State of the NIMH
Thomas R. Insel, M.D., Director, NIMH

NIMH Director, Thomas InselDr. Insel began his remarks by describing the public health burden of mental disorders in the United States and globally. In the United States, in 2010, neuropsychiatric disorders (mood and behavioral disorders and neurological disorders) accounted for a greater percentage of years lost to illness, disability, or premature death—at 18.7 percent—than heart disease, cancer, and all infectious diseases. Dr. Insel said that chronic noncommunicable diseases will be to the 21st century what infectious diseases were to the 20th century, and that “brain disorders, both neurodevelopmental and neurodegenerative diseases, will be the most disabling and certainly the most costly of these chronic diseases.” He pointed out that although the U.S. suicide rate has remained high over the past two decades, with 39,518 suicides reported in 2011, it is challenging to keep the impact of mental health disorders fresh in the public eye. In addition, not enough is known about how the brain works to address the burden of brain disorders; there is an enormous need for new tools for understanding the brain and for translating new insights into cures.

To help focus resources on the development of new ways to understand the brain, on April 2, 2013, President Obama launched the BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies). This initiative will “accelerate the development and application of new technologies that will enable researchers to produce dynamic pictures of the brain that show how individual brain cells and complex neural circuits interact at the speed of thought.” Dr. Insel said that these efforts may eventually lead to the development of new tools and more effective interventions for mental disorders. He also remarked that the BRAIN Initiative, which NIH Director Francis Collins has adopted as one of his defining projects, coincides with the pace of scientific discovery over the past several years, during which a number of stunning breakthroughs have been made in brain imaging and in other areas of brain science, including the field of brain/machine interfaces. NIH has taken up the President’s challenge by beginning to implement a rigorous plan, presented in Brain 2025: A Scientific Vision—BRAIN Working Group Report to the Advisory Committee to the Director, NIH, to develop new tools for understanding neural circuit function and for capturing a dynamic view of the brain in action. NIH recently awarded the first BRAIN Initiative grants, with about $46 million supporting 58 projects in fiscal year 2014.

Dr. Insel said that although this work is exciting and encouraging, it is focused on tool development; thus, most major discoveries will occur in the future. At this time, we still do not know enough to prevent, ensure recovery from, or cure most serious mental illness (SMI). In speaking about how to bend the curve and move forward, Dr. Insel assessed where we are in the process of transforming diagnostics, therapeutics, and the culture of science and discovery—a transformation that will be essential for success. For diagnostics, he said the field needs to move away from thinking in terms of mental illnesses as behavioral disorders, to thinking about them as brain disorders; for therapeutics, from thinking about chemical imbalances to looking at circuit dysfunction and at circuit-tuning as a way to address conduction defects of the brain; and for transforming the culture of science, from the idea of owning data to sharing data and from viewing patients as subjects of research to ensuring that patients are research partners.

Dr. Insel said that the current fragmented system focused mainly on diagnosis by symptoms alone, but controlling symptoms is not always successful and will no longer suffice. The problems associated with the mental health system include limited access to treatment and poor treatment adherence, and require a bundle of effective and accessible solutions that are less expensive. As new tools yield new diagnostics, the goal will be to use them to aggressively pursue better treatments more quickly. Dr. Insel reviewed an example of a recent NIMH success in developing a therapeutic intervention—the Recovery After an Initial Schizophrenia Episode (RAISE) project. RAISE seeks to change fundamentally the trajectory of schizophrenia and to improve outcomes through coordinated and aggressive treatment in the earliest stages of the illness. RAISE focuses on preventing relapse by providing patients with a toolbox of interventions; Dr. Insel noted that NIMH will be working with SAMSHA to implement RAISE in communities throughout the country. He noted that this work leads to “one of the defining questions of the decade” for NIMH: whether psychosis can be prevented in the first place by employing a broad array of interventions. He also remarked that the culture of science and discovery—from informed consent, to trial design, to how data are collected, analyzed, shared, and used—is changing as it must so that we can “get to new diagnostics, new therapeutics, prevention, recovery, and cure.” But the culture of academia that makes it easy to avoid sharing data also must change. At NIMH, Dr. Insel said, nearly all funded efforts are expected to have a level of standardization and integration as well as data sharing plans.

NIMH Strategic Plan
Kevin Quinn, Ph.D., Acting Director, Office of Science Policy, Planning, and Communications, NIMH

Kevin Quinn, Ph.D., Acting Director, NIMH Office of Science Policy, Planning, and CommunicationsDr. Quinn said that the 2008 NIMH Strategic Plan provided stakeholders with a broad view of the path forward in addressing mental illness. He remarked that in 2012, the Institute began a dialogue with the National Advisory Mental Health Council about revising the 2008 Plan; however, careful review of all of the scientific developments that had occurred in the field in the past five years indicated that the new plan must be much more than a simple update of the 2008 Plan—as the scientific landscape has changed. The new Plan will guide research efforts and priorities from 2015 to 2020. Dr. Quinn reviewed the process involved and said that the Plan includes multiple cross-cutting themes and is organized according to four Strategic Objectives (SOs), supported by strategic research priorities (i.e., guidance to the research community on how to achieve Plan goals) and Institute-initiated funding opportunity announcements (to elicit targeted guidance for near-term needs in different research areas) developed by Program staff.

Alliance members sharing their viewsDr. Insel asked for feedback from Alliance members on the 2015-2020 Draft NIMH Strategic Plan, emphasizing the critical value of their input as major stakeholders. The Plan will be posted for public comment via the Federal Register in November. Initial comments from Alliance members included those regarding the need for aspirational goals in the Plan; the need for metrics to measure success and track progress; whether the Plan will include the role of environmental risk factors in prevention; whether the Plan will focus on lifespan issues, including long-term care for people with chronic SMI; and the need for a greater focus on health services research, with more emphasis on collaborative care and health care services delivery. Dr. Insel said that data sharing is a cross-cutting theme and that the data does not belong to a study or study investigators, but to the country as a national resource.

Mood Network: The Mood Patient-Powered Research Network
Andrew A. Nierenberg, M.D., Director, Bipolar Clinic and Research Program; Associate Director, Depression Clinical and Research Program; Director, Clinical Research Support Office, Clinical Research Program, Massachusetts General Hospital

Andrew Nierenberg, M.D., Director, Bipolar Clinic and Research Program; Associate Director, Depression Clinical and Research Program; Director, Clinical Research Support Office, Clinical Research Program; Massachusetts General HospitalDr. Nierenberg provided an overview of the PCORI effort most relevant to mental health—the Mood Patient-Powered Research Network (Mood-PPRN). PCORI was developed to address the lack of sufficient evidence to support specific areas of clinical practice, by conducting patient-centered comparative clinical effectiveness research (CER) using a new model of collaboration among patients, clinicians, and researchers. Often clinical research fails to improve care; PCORI addresses this issue by centering research on patients and by implementing the findings and evaluating the outcomes that matter to them. The Mood-PPRN is part of PCORI’s PCOR-Net, the National Patient-Centered Clinical Research Network for conducting CER. PCOR-Net is a collaborative effort to build an infrastructure—a national patient-centered research network—for others to use to conduct CER. PCOR-Net includes 11 Clinical Data Research Networks and 18 PPRNs. PPRNs represent a broad range of conditions, are spread throughout the country, represent a variety of populations, and cover both rare and non-rare diseases.

The Mood Network, the only psychiatric PPRN, will be used to find the best interventions for mood disorders that lead to the best relevant outcomes, as defined by patients. The network will also provide opportunities for patients to participate in CER and to be engaged in all parts of the research. Dr. Nierenberg said that the ultimate goal of this five-year project is to transform the lives of people with mood disorders by conducting “careful [prospective] comparative effectiveness trials that are embedded within routine care” and collecting clinically useful data through electronic medical records (EMRs) and patient-recorded outcomes. The Mood-PPRN will aggregate data from these EMRs and integrate the patient-reported outcome data into a comprehensive database. The network also will establish the infrastructure for obtaining and processing bio-samples to help understand the biology of mood disorders. Dr. Nierenberg said they will approach a wide group of clinicians to participate and will work with advocacy groups and others to create a network of more than 50,000 patient-partners nationwide. He also provided an overview of the proposed comparative effectiveness trial to investigate whether 5,000 young people (ages 10 to 24) with bipolar disorder are best treated with a second-generation antipsychotic alone or with both a second generation-antipsychotic and a mood stabilizer.

During the discussion period, Alliance members asked about the timeframe for releasing the different findings; how the PPRN will get researchers involved; data security and IRB issues; and how physicians will be incentivized to participate. Several Alliance members suggested exploring the idea of working with large HMOs and/or pharmaceutical companies to recruit large numbers of patients and clinicians. Dr. Insel said that recent research demonstrates how common diseases are actually collections of rare diseases, and efforts such as the Mood-PPRN, which examine mood problems in the context of co-occurring conditions, may allow us to identify subgroups that require different kinds of interventions or have different vulnerabilities.

Opportunities Provided by Health IT Advances
Karan Singh, M.B.A., Co-founder,

Karan Singh, M.B.A, Co-founder, Ginger.ioMr. Singh began his presentation by talking about a movement that has been building over the past few years to combine newer and richer sources of data with human-centric design to achieve better healthcare and health outcomes, lower costs, and increase capacity and access to care. ( seeks to help realize these goals through the use of mobile data (collected from smartphones) and behavioral analytics. Mr. Singh said that ‘wearables,’ and particularly smartphones, increasingly are filling the information gaps about what happens to patients between healthcare visits. “That world is starting to change,” he said, “because we are starting to get a much better sense for what’s happening outside the clinic.”’s three-part platform, which consists of a smart phone app, a behavioral analytics engine, and care team interventions, enables a “screen, sort, support” approach to population health that pairs patients with the right support needed at the right time. The company is working with a number of clinical partners to learn what is effective in different settings and how to create experiences that do not feel medical for patients. An example of this approach is Mood Matters, which, through a consumer-facing smartphone app, seeks to better understand the causes and progression of depression. Over the last three months, Mood Matters has screened nearly 200,000 patients who were recruited directly online. Through such health information technology efforts, Mr. Singh said, care is moving from episodic to continuous, from physician-oriented to patient-centered, from subjective to objective, and from small data to big data, and patients are empowered to take control of their health. He also said privacy is critical in mental health, but noted that in his company’s work, the opt-out rate related to privacy concerns has been very low.

Mr. Singh remarked that this approach to collecting and analyzing data to improve care can be implemented now and that the Alliance should be part of the dialogue, which will involve, for example, helping IRBs adapt, changing funding cycles, focusing on public/private partnerships and moving much faster to gather data. Comments and questions from Alliance members included those regarding the difficulties of getting data collected online published; how to assess patients over time to find behavioral-based clusters that drive interventions; and, how to sustain patient participation and keep patients engaged. Other comments involved the potential of voice analytics; the possibility of using other interventions or metrics; the importance of caregiver support; how to create efficiency gains without adding to providers’ problems; how this approach would be adapted for different severities of illness; details on mobility data; and, the importance of privacy and data security. During the discussion, Dr. Insel remarked that issues around privacy are evolving, particularly regarding who will own the data. Mr. Singh agreed with Dr. Insel’s earlier remark that a more open and collaborative culture is emerging, which includes data sharing.

Assessing Risk and Protective Factors for Suicide in U.S. Army Soldiers (ARMY STARRS)
James Churchill, Ph.D., Program Officer, Army STARRS, NIMH, and Michael Schoenbaum, Ph.D., Senior Advisor, Mental Health Services, Epidemiology, and Economics, Office of Science Policy, Planning and Communications, NIMH

James Churchill, Ph.D., Study Director, Army Study to Assess Risk and Resilience in Servicemembers, NIMH AND Michael Schoenbaum, Ph.D., Senior Advisor, Mental Health Services, Epidemiology, and Economics; Office of Science Policy, Planning and Communications, NIMHDr. Churchill and Dr. Schoenbaum jointly presented information on the Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS), a partnership between NIMH and the US Army to address increasing rates of suicide among Army Soldiers. Dr. Churchill provided an overview of how the study originated and the roles of the various research participants (the Army, academic investigators, and NIH). He said that study goals are to identify risk and protective factors for suicide and psychological health; inform the development of evidence-based interventions; and, rapidly deliver actionable findings. Dr. Churchill remarked that the study, which includes 110,000 volunteer participants, uses a multifaceted data-collection approach, with two retrospective and four prospective data components.

Dr. Schoenbaum began by noting that “…from 2004 to 2008, when the Army first approached NIMH, the suicide rate among active duty Soldiers had approximately doubled,” and “from that point on to the current peak in 2012, the suicide rate continued to go up, and ultimately it…tripled between 2004 and 2012, before turning down in 2013.” However, the evidence emerging from Army STARRS, “the largest study of suicide risk and resilience conducted in any population…with this kind of rigor,” about the rise in the suicide rate does not support conventional wisdom. Researchers looked at several factors and found that relaxed accession waivers did not appear to contribute to the increase, nor did serving under stop loss, living in individual housing, or multiple deployments. Rather, one contributing factor that was identified was a history of recent contact with behavioral healthcare providers. He noted that Army STARRS algorithms can identify subgroups of Soldiers with a very high predicted risk of suicide. Dr. Schoenbaum emphasized that the interventions that lower a Soldiers’ suicide rate in the highest risk group could be applied more broadly to result in a significant reduction in total Army suicides. In addition, the lessons learned about suicide risk could be adapted for the other military branches and possibly carry over to civilian settings. Dr. Churchill said that the study is starting to mix outcomes with the baseline and administrative data to make the effort more powerful.

Alliance members commenting on presentations
During discussion with Alliance members, the speakers provided more information about the study population. Regarding possible backlash in terms of the potential for data misuse, Dr. Schoenbaum said that although there is always a risk of data being used in adverse ways, ironclad confidentiality protections are in place. Several Alliance members said that their groups are facing similar questions involving privacy and data security.


Alliance members listening to presentationsAt the end of the day, Alliance members engaged in dialogue asking about many of the topics they had heard about, including the status of the BRAIN Initiative and the plans for partner involvement. Others commented on the overall status of the NIH budget and how the lack of major growth might affect funding and research at NIH and NIMH. Dr. Insel shared his hope that some ongoing efforts may inspire policy makers to think of NIH as an investment and also spur them to ensure the healthy growth of that investment over the next many years. In closing, he noted that, in the field of mental health, there is an urgent need for new, more rational, effective methods to treat and diagnose mental illness, and for greater public health impact.   

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