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Clinical Trial of Cognitive Behavioral Treatment for Posttraumatic Stress Disorder in Women Veterans
This study is currently recruiting patients.
| Sponsored by: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
Purpose
The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure therapy for treating PTSD and associated problems in female veterans and active duty military personnel. We propose to compare exposure therapy, Prolonged Exposure, with a comparison therapy that focuses on current problems, Present Centered Therapy.
The study is a randomized clinical trial involving 384 female veterans and active duty personnel in 11 VA medical centers and 1 DoD medical center. All subjects, even self-referrals, will enter the study through referrals by mental health clinicians at the participating sites. Following informed consent, subjects will be screened for inclusion and exclusion diagnoses. If they meet these criteria and agree to participate, they will be randomly assigned to one of the two treatments, which will occur weekly for 10 weeks. Subjects will be assessed before treatment, immediately following treatment, and 3 and 6 months after the end of treatment. The primary outcome is PTSD severity. Secondary outcomes are anxiety and depression. Exploratory outcomes include associated features of PTSD, such as dissociation and substance abuse; psychosocial functioning, quality of life, physical health, satisfaction with treatment, and service utilization. Both treatments will be described in detail in a treatment manual and monitored intensively to ensure that they are administered correctly.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Stress Disorders, Post-Traumatic |
Behavior: Prolonged Exposure Behavior: Present-Centered Therapy |
Phase II Phase III |
MedlinePlus related topics: Post-Traumatic Stress Disorder
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment
Official Title: CSP #494, A Randomized Clinical Trial of Cognitive Behavioral Treatment for PTSD in Women Veterans
Expected Total Enrollment: 432
Study start: July 2001;
Expected completion: December 2005
Intervention: Patients will be randomized to one of two interventions: Prolonged Exposure (PE) consisting of 10 weekly treatment sessions that include education about and exposure to the memories of the trauma to which the patient was engaged; or Present Center Therapy (PCT), which will consist of a control therapy of the same duration that will provide emotional support for the trauma victim.
Primary Hypothesis: Prolonged Exposure (PE) will be more effective than Present-Centered Therapy (PCT) for the treatment of PTSD due to military-related trauma in women veterans. PE specifically targets PTSD symptoms, and the CAPS, our primary outcome measure. The Clinician Administered PTSD Scale (CAPS) is considered to be the gold-standard for PTSD assessment.
Secondary Hypothesis: PE will be more effective than PCT for treating the anxiety and depression that often are comorbid with PTSD.
Study Abstract: As noted in a recent report on the VA Women's Health Project, it is important to study women veterans because they are increasingly seeking VA health care. For many women veterans, Postraumatic Stress Disorder (PTSD) is a specific healthcare concern that is associated with substantial psychosocial and functional disability.
The study was proposed in response to the Research Priority Announcement on Postraumatic Stress Disorder research issued August 1, 1997, as a study aimed a special subpopulation of VA patients with PTSD: women veterans who have been traumatized during their military service.
The first planning meeting for the study was held January 20-21, 2000 in Washington, DC. The protocol was submitted on August 1, 2000; it was reviewed and approved by the Cooperative Studies Evaluation Committee on October 10, 2000. Intake of training cases is expected to begin 01/01/2002.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
Criteria
In order to be included, subjects must be:
Subjects will be excluded for any of the following reasons:
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