Enhancing clinical trial design of interventions for posttraumatic stress disorder
Open accessAbstract
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.
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The role and interpretation of pilot studies in clinical research
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- Authors
- Leon, A. C., & Davis, L. L.
- Affiliations
- Weill Cornell Medicine (US)
- University of Alabama (US)
- Corresponding author
- Leon, Andrew C.
- Venue
- Journal of Traumatic Stress
- Publisher
- Wiley
- Published
- 2009-11-09
- Volume
- 22
- Issue
- 6
- Pages
- 603-611
- ISSN
- 0894-9867 (ISSN-L)
- 1573-6598
- PMC
- PMC2798901
- OpenAlex
- W2026240470
- Cited by
- 26
- References
- 8
- Citations by year
- 2025: 1 · 2024: 1 · 2022: 2 · 2020: 1 · 2019: 2 · 2017: 1 · 2016: 1 · 2015: 5 · 2014: 1 · 2012: 3
- FWCI
- 3.05
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Traumatic Stress (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Mental Health (P30MH060570, R01MH060447)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Psychology › Clinical Psychology › Posttraumatic Stress Disorder Research
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- post-traumatic stress disorder, clinical trial design, randomized controlled trials, signal detection, methodological recommendations, veterans, trauma intervention
- MeSH terms
- Combat Disorders, Data Interpretation, Statistical, Humans, Research Design, Stress Disorders, Post-Traumatic, United States, Veterans, Models, Statistical, Bias, Randomized Controlled Trials as Topic, Treatment Outcome, Sample Size, Patient Selection
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