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A Randomized Clinical Trial of Cognitive-Behavioral Treatment for Post-Traumatic Stress Disorders in Women

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ClinicalTrials.gov Identifier: NCT00032617
Recruitment Status : Completed
First Posted : March 28, 2002
Last Update Posted : September 24, 2010
Sponsor:
Information provided by:
VA Office of Research and Development

March 27, 2002
March 28, 2002
September 24, 2010
August 2002
April 2006   (Final data collection date for primary outcome measure)
summing totals of 17 DSM-IV symptoms [ Time Frame: 10 weeks ]
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Complete list of historical versions of study NCT00032617 on ClinicalTrials.gov Archive Site
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A Randomized Clinical Trial of Cognitive-Behavioral Treatment for Post-Traumatic Stress Disorders in Women
CSP #494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women (PTSD)

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.

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, Posttraumatic 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 Posttraumatic 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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Stress Disorders, Post-Traumatic
  • Procedure: Prolonged Exposure
    trauma-focused exposure therapy
  • Procedure: Present Centered Therapy
    therapy that focuses on current problems
  • Active Comparator: 1
    Prolonged Exposure
    Intervention: Procedure: Prolonged Exposure
  • Active Comparator: 2
    Present Centered Therapy
    Intervention: Procedure: Present Centered Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
284
432
April 2006
April 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • female veterans or active duty personnel with a current diagnosis of PTSD due to any type of trauma;
  • have experienced trauma no less than 3 months prior to entering the trial;
  • have at least one clear memory of the trauma that caused their PTSD (sufficient for constructing a scene to be used in PE);
  • consent to be randomized into treatment;
  • not receive other psychotherapy for PTSD during the 10 weeks of active treatment;
  • psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed;
  • if on psychoactive medication be on a stable medication regimen for a minimum of 2 months prior to entering the trial.

Exclusion Criteria:

  • current substance dependence;
  • prior substance dependence that has not been in remission at least 3 months;
  • any current psychotic symptoms; current Mania or Bipolar Disorder;
  • prominent current suicidal or homicidal ideation;
  • any severe cognitive impairment or history of Organic Mental Disorder;
  • current involvement in a violent relationship;
  • self-mutilation within the past 6 months.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00032617
494
Yes
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Friedman, Matthew - Study Chair, Department of Veterans Affairs
VA Office of Research and Development
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Study Chair: Matthew J. Friedman, MD PhD VA Medical & Regional Office Center
VA Office of Research and Development
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP