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

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032617
First received: March 27, 2002
Last updated: September 22, 2010
Last verified: September 2010
  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 Intervention Phase
Stress Disorders, Post-Traumatic
Procedure: Prolonged Exposure
Procedure: Present Centered Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: CSP #494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women (PTSD)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • summing totals of 17 DSM-IV symptoms [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 284
Study Start Date: August 2002
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032617

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

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Friedman, Matthew - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032617     History of Changes
Other Study ID Numbers: 494
Study First Received: March 27, 2002
Last Updated: September 22, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
PTSD
Stress Disorder
Trauma

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Disease
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014