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

September 22, 2010 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • VA Eastern Colorado Health Care System, Denver
    • Florida
      • Bay Pines, Florida, United States, 33708
        • VA Medical Center, Bay Pines
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical and Rehab Center, Decatur
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Southeast Veterans Healthcare System, New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • VA Maryland Health Care System, Baltimore
      • Bethesda, Maryland, United States, 20814
        • Walter Reed (DCI-HUC)
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • VA Medical Center, Jamaica Plain Campus
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5153
        • New Mexico VA Health Care System, Albuquerque
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • VA Medical Center, Cincinnati
      • Cleveland, Ohio, United States, 44106
        • VA Medical Center, Cleveland
    • Oregon
      • Portland, Oregon, United States, 97201
        • VA Medical Center, Portland
    • Texas
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System, Dallas
    • Vermont
      • White River Junction, Vermont, United States, 05009-0001
        • VA Medical & Regional Office Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Prolonged Exposure
Procedure: Prolonged Exposure
trauma-focused exposure therapy
Active Comparator: 2
Present Centered Therapy
Procedure: Present Centered Therapy
therapy that focuses on current problems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
summing totals of 17 DSM-IV symptoms
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Study Chair: Matthew J. Friedman, MD PhD, VA Medical & Regional Office Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

March 27, 2002

First Submitted That Met QC Criteria

March 27, 2002

First Posted (Estimate)

March 28, 2002

Study Record Updates

Last Update Posted (Estimate)

September 24, 2010

Last Update Submitted That Met QC Criteria

September 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 494

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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