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Contemp Clin Trials. 2015 Mar;41:75-84. doi: 10.1016/j.cct.2014.11.017. Epub 2014 Nov 29.

Design of VA Cooperative Study #591: CERV-PTSD, comparative effectiveness research in veterans with PTSD.

Author information

1
National Center for PTSD (Executive Division), White River Junction, VT and Geisel School of Medicine at Dartmouth, Hanover, NH, USA. Electronic address: paula.schnurr@dartmouth.edu.
2
Cincinnati VA Medical Center and University of Cincinnati, Cincinnati, OH, USA.
3
National Center for PTSD (Dissemination and Training Division) and Stanford University School of Medicine, Palo Alto, CA, USA.
4
VA Cooperative Studies Program Coordinating Center, Palo Alto, CA, USA.
5
VA Cooperative Studies Program Coordinating Center, Palo Alto, CA, USA; Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA.
6
Duke University Medical School, Durham, NC, USA.
7
University of Pennsylvania, Philadelphia, PA, USA.
8
National Center for PTSD (Behavioral Science Division), Boston University School of Medicine, and VA Boston Healthcare System, Boston, MA, USA.
9
Cooperative Studies Program Central Office, Department of Veterans Affairs Office of Research & Development, Washington, DC, USA.

Abstract

CERV-PTSD is a randomized controlled trial of two of the most effective treatments for PTSD, Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT). Despite solid evidence that both treatments are effective, there is limited evidence about their effectiveness relative to one another. The primary objective is to compare the effectiveness of PE and CPT for reducing PTSD symptom severity in a healthcare system that offers both treatments. The secondary objective is to compare the effectiveness of PE and CPT for reducing the severity of comorbid mental health problems and service utilization as well as improving functioning and quality of life. The tertiary objective is to examine whether discrepancy between patient preferences and treatment assignment reduces the effectiveness of each treatment. Exploratory analyses will examine whether demographic and clinical characteristics predict differential response to PE and CPT. The study is designed to randomize 900 male and female veterans with PTSD due to any traumatic military event to receive PE or CPT. The standard dose of treatment is 12 weekly sessions but veterans who improve more rapidly may finish in fewer sessions and veterans who improve more slowly may have additional sessions. The primary outcome is improvement in PTSD symptoms, measured during and after treatment and then 3 and 6 months later. As a large multi-site trial with men and women, CERV-PTSD is designed to advance the delivery of care for PTSD by providing conclusive information about whether one treatment is better than the other, overall, and for different types of patients.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01928732.

KEYWORDS:

Cognitive–behavioral therapy; Comparative effectiveness; Posttraumatic stress disorder; Randomized clinical trial; Veterans

PMID:
25457792
DOI:
10.1016/j.cct.2014.11.017
[Indexed for MEDLINE]

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