This manuscript was prepared with funding from the National Institute of Mental Health and administrative support of VA Office of Research and Development.
Special Section: Innovations in Trauma Research Methods, 2008
Enhancing clinical trial design of interventions for posttraumatic stress disorder†
Article first published online: 9 NOV 2009
Copyright © 2009 International Society for Traumatic Stress Studies
Journal of Traumatic Stress
Special Issue: Special Section: Innovations in Trauma Research Methods, 2008
Volume 22, Issue 6, pages 603–611, December 2009
How to Cite
Leon, A. C. and Davis, L. L. (2009), Enhancing clinical trial design of interventions for posttraumatic stress disorder. J. Traum. Stress, 22: 603–611. doi: 10.1002/jts.20466
- Issue published online: 21 DEC 2009
- Article first published online: 9 NOV 2009
The 2008 Institute of Medicine review of interventions research for posttraumatic stress disorder (PTSD) concluded that new, well-designed studies are needed to evaluate the efficacy of treatments for PTSD. The Department of Veterans Affairs (VA), the Department of Defense, and the National Institute of Mental Health convened a meeting on research methodology and the VA issued recommendations for design and analysis of randomized controlled clinical trials (RCTs) for PTSD. The rationale that formed the basis for several of the components of the recommendations is discussed here. Fundamental goals of RCT design are described. Strategies in design and analysis that contribute to the goals of an RCT and thereby enhance the likelihood of signal detection are considered.