A: The National Institute of Mental Health (NIMH) and the U.S. Army are partnering to conduct the Army Study To Assess Risk and Resilience in Servicemembers, the largest study of mental health risk and resilience factors ever conducted among military personnel. The purpose of Army STARRS is to identify – as quickly as possible – factors that protect or pose risks to Soldiers’ emotional well-being and overall mental health so that the Army may apply the knowledge to its ongoing health promotion, risk reduction, and suicide prevention efforts.

A: Mental health problems and suicide are issues that affect Americans from all walks of life, yet, historically, the suicide rate among Army personnel has been below that of the civilian population. Since 2002, however, the suicide rate among Soldiers has risen significantly. The rate reached record levels in 2007 and again in 2008 and 2009. It was these numbers that prompted the Army to engage the National Institute of Mental Health (NIMH) in helping to address this issue. Army STARRS is a direct response to the Army’s request to NIMH to enlist the most promising scientific approaches for addressing Soldiers’ overall health, well-being, readiness, and the prevention of self-harm.

A: The Army sought out NIMH as a partner for this study because of NIMH’s public health mission and its expertise in using innovative research approaches to understand, prevent, and treat mental health problems. The Army and NIMH signed a memorandum of agreement in October 2008 authorizing NIMH to conduct an extensive investigation with Army funding.

NIMH has assembled a group of renowned experts to carry out this research including teams from the Uniformed Services University of the Health Sciences (USUHS), University of California, San Diego, University of Michigan, Harvard Medical School, and NIMH. Additional Army and NIMH program staff will contribute to the oversight and implementation of the study. This research team brings together international leaders in military health, health and behavior surveys, epidemiology, suicide, and genetic and neurobiological factors involved in psychological health and suicidal behavior.

The interdisciplinary team is led by Robert J. Ursano, MD, of the Uniformed Services University of the Health Sciences and Murray Stein, MD, MPH,of the University of California, San Diego. The study’s other investigators are:

• Steven G. Heeringa, PhD, University of Michigan
• Ronald C. Kessler, PhD, Harvard Medical School
• Lisa J. Colpe, PhD, MPH, NIMH
• Michael Schoenbaum, PhD, NIMH

NIMH and Army oversight and implementation leadership include:

• Deborah Konopko, JD, Army Executive Director, Army STARRS
• Philip Wang, MD, DrPH, Study Director, Army STARRS
• Kevin Quinn, PhD, NIMH Program Official, Army STARRS
• LTC Steven Cersovsky, MD, MPH, Preventive Medicine Consultant, Army STARRS
• Kenneth Cox, MD, MPH, Medical Informatics Consultant, Army STARRS

A: The overall model for this study is the Framingham Heart Study, in which a collection of detailed epidemiologic data from a target population have made it possible to generate and study new hypotheses about the role of risk factors in causing illness.

Army STARRS will work with soldiers from all phases of Army service. It will have both retrospective components—involving tens of thousands of de-identified health and administrative records—and prospective components, in which soldiers are followed over time.

The four components of Army STARRS are:

• Historical Data Study
  The Historical Data Study will analyze existing Army data to identify risk and protective factors related to psychological resilience, mental health, risky behaviors, and suicide. The Army will remove all personal identifiers (such as name and Social Security Number) before sharing existing data with the Army STARRS research team.
• New Soldier Study
  The New Soldier Study will collect information to assess the health, personal characteristics, and prior experiences of new Soldiers as they begin their Army service.
• All Army Study
  In the All Army Study, researchers will assess Soldiers’ psychological and physical health; events encountered during training, combat, and non-combat operations; and life and work experiences across all phases of Army life. This information will be used to determine how these factors affect Soldiers psychological resilience, mental health, and risk for self-harm.
• Soldier Health Outcomes Study
  The Soldier Health Outcomes Study is comprised of two case-control studies of participants who have exhibited suicidal behavior compared with those who have not. This component will attempt to identify characteristics, events, experiences, and exposures that predict negative (or positive) health and behavior outcomes.

A: Suicide is a relatively rare event (in statistical terms, for instance, there were 115 confirmed suicide deaths among Army Soldiers in 2007, a rate of 18.1/100,000 Soldiers). Thus very large samples are required for in-depth scientific analysis, which this study will provide.

In addition, the reasons for suicidal behavior are complex. While stressful life events are among the risk factors for suicide attempts, stress alone does not explain suicide. Most people exposed to severe stress do not respond with suicidal behavior. One of the goals of Army STARRS is to better understand the factors that shape vulnerability to suicidal behavior as well as the factors that protect against self-harm.

A: Researchers have identified a wide variety of factors that may increase risk for suicide in civilian populations. However, very little is known about the strength of each factor or how multiple factors may combine to increase risk for different individuals in different situations and at different points in their lives. The Army STARRS project will address a wide spectrum of both risk and protective factors – those that are already known to have an impact on mental health risk and suicide as well as many that are suspected of contributing to well-being, mental illness, and self-harm. Here are some examples of factors that Army STARRS will consider:

• Stress of all kinds, past and present (e.g., interpersonal relationships, legal and economic difficulties, family illness)
• Deployments, exposure to combat and trauma, unit cohesion and morale, injuries, and bereavement
• Exposure to trauma outside of deployment
• Strategies for coping with stress and adversity
• Family and personal history (e.g., personal achievements, family stability, childhood experiences, mental illness, substance use patterns)
• Personality traits and temperament (e.g., interpersonal skills, degree of openness; self-discipline, cooperativeness)
• Demographic characteristics (e.g., sex, age, ethnicity, educational level)
• Social connections and social support

The study will also investigate brain systems that underlie mental health and that may provide markers of suicide risk and psychological resilience. Executive function, for example, refers to the brain-based capacity for carrying out tasks that require focused attention, such as problem solving, decision-making, and planning. The brain also coordinates the body’s stress response system. Previous studies have found the function of this system to be altered in people with mental disorders, and those who have experienced trauma or severe stress. Accordingly, various strategies will be used to assess the health of this system.

Genes shape brain activities involved with mood, reward, and psychological traits and disorders. Previous studies have identified associations between specific genes and behavioral traits as well as vulnerability to disorders of mental health. Army STARRS will use state-of-the-art techniques to investigate candidate genes for links to suicide risk and psychological resilience.

A: Army STARRS is a five-year study and will run through 2014. Findings will be reported as they become available so that the Army may apply them in ongoing health promotion, risk reduction, and suicide prevention efforts for Soldiers.

A: NIMH and the Army have put multiple safeguards in place at all levels of the study and in all aspects of the study to protect the confidentiality of participating Soldiers. Here are some examples of these safeguards:

• Informed consent – Participation in Army STARRS is voluntary. Researchers will give servicemembers adequate information about the study and about confidentiality protections so that they can make an informed decision about whether or not to participate.
• Information that could be used to identify individual servicemembers will be removed from survey responses and other study information. Data will be combined and analyzed and reported only in the aggregate, which will preserve Soldiers’ anonymity.
• Certificates of Confidentiality—Certificates of Confidentiality are used in Army STARRS to protect identifiable research information from forced or compelled disclosure. They allow the researchers to refuse to disclose identifying information about servicemembers in civil, criminal, administrative, legislative, or other proceedings. Certificates of Confidentiality are often used in studies collecting information that could have adverse consequences for participants. By protecting researchers from being compelled to disclose information that would identify research subjects, these Certificates of Confidentiality help to minimize risks to subjects by adding an additional level of protection for maintaining confidentiality of private information.
• Institutional Review Boards (IRB) —IRBs are specially constituted review bodies established to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. The IRBs at all research organizations involved in Army STARRS (NIMH, USUHS, The University of Michigan, Harvard University) have reviewed and approved study plans for protecting the welfare of all study participants.