A Randomized Clinical Trial of Cognitive-Behavioral Treatment for Post-Traumatic Stress Disorders in Women
Completed · Phase 3
Conditions studied: Stress Disorders, Post-Traumatic
In brief
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.
Key facts
- Study ID
- NCT00032617
- Run by
- US Department of Veterans Affairs
- People needed
- 284
- Starts
- 2002-08-01
- Expected to finish
- 2006-04-01
- Last updated by the study team
- 2010-09-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- VA Eastern Colorado Health Care System, Denver — Denver, Colorado, United States
- VA Medical Center, Bay Pines — Bay Pines, Florida, United States
- Atlanta VA Medical and Rehab Center, Decatur — Decatur, Georgia, United States
- Southeast Veterans Healthcare System, New Orleans — New Orleans, Louisiana, United States
- VA Maryland Health Care System, Baltimore — Baltimore, Maryland, United States
- Walter Reed (DCI-HUC) — Bethesda, Maryland, United States
- VA Medical Center, Jamaica Plain Campus — Boston, Massachusetts, United States
- New Mexico VA Health Care System, Albuquerque — Albuquerque, New Mexico, United States
- VA Medical Center, Cincinnati — Cincinnati, Ohio, United States
- VA Medical Center, Cleveland — Cleveland, Ohio, United States
- VA Medical Center, Portland — Portland, Oregon, United States
- VA North Texas Health Care System, Dallas — Dallas, Texas, United States
- VA Medical & Regional Office Center — White River Junction, Vermont, United States
Full record on ClinicalTrials.gov
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