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Completed Research Projects
Title: A Randomized Clinical Trial for Cognitive-Behavioral Treatment for PTSD in Women (See DoD-125)
Synopsis: This study compared the ability of two types of treatment for mental and emotional disorders for women with military-related posttraumatic stress disorder.
Overall Summary: See project objective.
Overall Project Objective: See also DOD-125. Randomized clinical trial comparing two types of individual psychotherapy for treating Post-Traumatic Stress Disorder (PTSD) in 384 female veterans and active duty personnel at 12 sites. This trial tests the primary hypothesis that Prolonged Exposure will be more effective than Present-Centered Therapy for the treatment of PTSD due to military-related trauma in women, as measured by the Clinician Administered PTSD Scale at three months post-treatment. This is part of a VA-DoD program on stress responses and PTSD. (DoD-125 and VA-74)
Results to Date: There have been no study findings yet, as the research has just begun. The studys total enrollment, since its approval date is three. There is currently one patient enrolled in the studys training phase. A second patient completed all study requirements 10/28/02. The third patient was withdrawn from the study due to inpatient hospitalization, unrelated to the study.
Project: VA-74
Agency: Department Of Veterans Affairs
Location: The Henry M. Jackson Foundation
P.I. Name: C C Engel,P P Schnurr
Status: Complete
Study Start Date: January 01, 2002
Estimated Completion Date: January 01, 2004
Specific Aims: Measure treatment outcome comprehensively, but effectively, in order to minimize subject burden and cost. Overall, five domains will be assessed: psychological factors, including PTSD and comorbid conditions such as depression and anxiety; psychosocial function and quality of life; physical health status; satisfaction with treatment; and utilization of physical and mental health services. -Primary outcome: PTSD severity, as measured by the CAPS; additional measures of PTSD are the PTSD Checklist and the percentage of subjects who show clinically significant change on the CAPS, defined as a decrease of 10 or more points. -Secondary Outcomes: Depressive symptoms, as measure by the Beck Depression Inventory; and anxiety symptoms, as measure by the State-Trait Anxiety Inventory. -Exploratory outcomes: Drug and alcohol use, as measured by ASI subscales; SF-36 Health Status Questionnaire; Trauma Symptom Inventory subscales; Quality of Life Inventory; satisfaction with treatment; and service utilization.
Methodology: 384 women with PTSD will be randomized to one of two treatment arms, and will receive therapy ten times over a ten week period with follow-ups occurring at three and six months. Effects of exposure therapy on PTSD symptoms have led us to make PTSD severity our primary outcome. Effects of exposure therapy on anxiety and depressive symptoms have led to the specific measures of these constructs being included as secondary outcomes.
Publications:
Schnurr P P, Friedman M J, Engel C C, Foa E B, Shea M T, Chow B K, Resick P A, Thurston V , Orsillo S M, Haug R , Turner C . JAMA.2007;297:820-30.
Schnurr P P, Friedman M J, Bernardy N C. J Clin Psychol.2002;58:877-89.
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