Research Applications, Benefits, and Risks: The STRONG STAR Consortium to Alleviate PTSD (STRONG STAR-CAP) will provide an array of cutting-edge clinical treatment trials and biological studies for Service Members and Veterans with partial to severe post-traumatic stress disorder (PTSD) and related conditions. A direct benefit of our clinical trials is that Service Members and Veterans should see increased access to effective treatments that can be tailored to their needs and help them to recover from the psychological wounds of war in a relatively short amount of time, allowing them to maintain happy and productive lives in continued military service or as civilians. Proposed clinical treatment trials take evidence-based psychological approaches (i.e., cognitive-behavioral therapy) tested with civilians and adapt them to enhance efficacy and increase accessibility for Service Members and Veterans. The goal is to offer personalized care for PTSD of varying levels of severity and complexity in settings that are convenient and decrease concerns about stigma (e.g., primary care clinics, the Internet, and a centralized location that takes worldwide referrals for intensive outpatient therapy). An innovative clinical trial evaluates whether an existing medication promising rapid relief in the treatment of PTSD can indeed provide a highly sought-after and more effective alternative to currently available medications. This trial ties in particularly well with other STRONG STAR-CAP studies seeking to understand the underlying biology of PTSD and could help investigators identify biomarkers influencing risk for, development of, and recovery from PTSD and related conditions, paving the way for new or improved preventions, diagnostics, and treatments. Risks with the treatment trials potentially include mild, temporary increases in symptoms that can be safely and effectively managed through patient education. Other minimal study risks include needle sticks for blood draws or administration of medication, and mild radiation exposure for imaging scans.

Projected Timeline: Because treatments are being evaluated within the Department of Veterans Affairs (VA) and Department of Defense (DoD) settings, if our trials show them to be effective and feasible, both agencies could immediately begin disseminating these treatments to their providers and implementing their use. Biomarker and neuroimaging studies also could yield findings that would be relevant to clinicians in the short term (e.g., within a few years, leading to tests to help confirm PTSD diagnosis or improvement) while simultaneously producing targets for future study and informing the development of new diagnostic, prevention, and treatment methods for years to come.

Contributions to the Field: STRONG STAR-CAP will expand much-needed efforts to evaluate and adapt evidence-based therapies from the civilian world and make them effective in the treatment of combat-related PTSD. At the same time, it will identify treatment-delivery modifications required to meet the needs of our warfighters and increase both clinician and patient use of evidence-based care. Similarly, the Consortium will advance research on medications for PTSD -- a heavily utilized form of treatment with insufficient scientific evidence for its efficacy -- by evaluating a promising new medication and identifying predictors of treatment response. The Consortium's efforts to identify biomarkers associated with PTSD susceptibility, development, and recovery will illuminate the underlying biology of PTSD, yielding novel insights on how best to prevent it, diagnose complicated cases, design new or improve existing medications to treat it, personalize treatment for patients' maximum benefit, and help more people achieve full recovery.

Public Benefit: With our clinical trials, we hope to develop programs to treat the largest percentage of Service Members possible to the point of loss of diagnosis or remission so they can remain operationally and functionally fit for military service. Similar aspirations exist in our clinical trials recruiting prior-service Veterans to allow them to regain their full potential for social and occupational functioning. To set goals any lower would be a disservice to our Service Members, Veterans, the DoD, the VA, and our nation. Additionally, the provision of clinically and cost-effective treatments for the psychological wounds of war could strengthen our Armed Forces and save billions of tax dollars otherwise needed to support a generation of Veterans with chronic PTSD. Since at least 7%-8% of the population will develop PTSD at some point, treatment advances made through STRONG STAR-CAP could be applied to help millions of Americans gain a new lease on life.