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

Further Study Details: 

Expected Total Enrollment:  432

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

In order to be included, subjects must be:

• 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.

Subjects will be excluded for any of the following reasons:

• 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.

Colorado
      Denver VA Medical Center, Readjustment Counseling 10B/RC4A, Denver,  Colorado,  80203,  United States; Recruiting
District of Columbia
      Walter Reed Army Medical Center HS RRB, Washington,  District of Columbia,  30207-5001,  United States; Recruiting
      Walter Reed Army Medical Center DCI HUC, Washington,  District of Columbia,  30207-5001,  United States; Recruiting
Florida
      Bay Pines VA Medical Ctr, Readjst. Coun. Serv. (10BRC3A), Bay Pines,  Florida,  33744,  United States; Recruiting
Georgia
      Atlanta VA Medical Center, Decatur,  Georgia,  30033,  United States; Recruiting
Louisiana
      New Orleans VA Medical Center, Mental Health Services (COS6), New Orleans,  Louisiana,  70146,  United States; Recruiting
Maryland
      Baltimore VA Medical Center (BT/MIRECC), Baltimore,  Maryland,  21201,  United States; Recruiting
      Bethesda Uniformed Services University, Bethesda,  Maryland,  20814-4799,  United States; Recruiting
Massachusetts
      Boston VA Medical Center, Women's Health Sci. Div. (116-B-3), Boston,  Massachusetts,  02130,  United States; Recruiting
New Mexico
      Albuquerque VA Medical Center, Albuquerque,  New Mexico,  87108,  United States; Recruiting
Ohio
      Cincinnati VA Medical Center, PTSD Unit 7E, Cincinnati,  Ohio,  45220,  United States; Recruiting
      Cleveland VA Medical Center, PTSD Service (32B), Cleveland,  Ohio,  44141,  United States; Recruiting
Oregon
      Portland VA Medical Center (P3 MHC), Portland,  Oregon,  97201,  United States; Recruiting
Pennsylvania
      Philadelphia Health Sys. Ctr. Treatment, Univ.Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Rhode Island
      Providence VA Medical Center Providence, Bldg. 14, Providence,  Rhode Island,  02908,  United States; Recruiting
Texas
      Dallas VA Medical Center, PTSD Services (151), Dallas,  Texas,  75216,  United States; Recruiting
Vermont
      White River Junction VA Medical and Regional Office Center, White River Junction,  Vermont,  05009,  United States; Recruiting

Study ID Numbers:  494
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  March 27, 2002
ClinicalTrials.gov Identifier:  NCT00032617
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08