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Home > "C" Clinical Trials Conditions > Clinical Trial of Cognitive Behavioral Treatment for Postraumatic Stress Disorder in Women Veterans  Clinical Trial of Cognitive Behavioral Treatment for Postraumatic Stress Disorder in Women Veterans
Clinical Trial of Cognitive Behavioral Treatment for Postraumatic Stress Disorder in Women Veterans
For Condition: Stress Disorders, Post-Traumatic
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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.
Total Enrollment: 432
Location and Contact Information:
White River Junction VA Medical and Regional Office Center *Recruiting*
White River Junction, Vermont, 05009
United States
Recruiting Paula Schnurr 802-296-5132
Providence VA Medical Center Providence, Bldg. 14 *Recruiting*
Providence, Rhode Island, 02908
United States
Recruiting Tracie Shea 401-444-1907
Philadelphia Health Sys. Ctr. Treatment, Univ.Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Edna Foa 215-746-3327
Bay Pines VA Medical Ctr, Readjst. Coun. Serv. (10BRC3A) *Recruiting*
Bay Pines, Florida, 33744
United States
Recruiting Peter Hayman 727-398-9343
Bethesda Uniformed Services University *Recruiting*
Bethesda, Maryland, 20814-4799
United States
Recruiting Charles Engel 202-782-8064
Cleveland VA Medical Center, PTSD Service (32B) *Recruiting*
Cleveland, Ohio, 44141
United States
Recruiting David Liebling 440-838-6055
Boston VA Medical Center, Women's Health Sci. Div. (116-B-3) *Recruiting*
Boston, Massachusetts, 02130
United States
Recruiting Susan Orsillo 617-232-9500
Denver VA Medical Center, Readjustment Counseling 10B/RC4A *Recruiting*
Denver, Colorado, 80203
United States
Recruiting Rodney Haug 303-393-2897
Baltimore VA Medical Center (BT/MIRECC) *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Jean Gearon 410-605-7465
Walter Reed Army Medical Center DCI HUC *Recruiting*
Washington D.C., District of Columbia, 30207-5001
United States
Recruiting Vivian Sheliga 202-782-0916
Cincinnati VA Medical Center, PTSD Unit 7E *Recruiting*
Cincinnati, Ohio, 45220
United States
Recruiting Dewleen Baker 513-475-6386
Albuquerque VA Medical Center *Recruiting*
Albuquerque, New Mexico, 87108
United States
Recruiting Diane Castillo 505-265-1711
Atlanta VA Medical Center *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Samuel Aguayo 404-728-7703
Portland VA Medical Center (P3 MHC) *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Irene Powch 503-220-8262
Dallas VA Medical Center, PTSD Services (151) *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Alina Suris 214-857-0334
Walter Reed Army Medical Center HS RRB *Recruiting*
Washington D.C., District of Columbia, 30207-5001
United States
Recruiting LTD C Engel 202-782-8064
New Orleans VA Medical Center, Mental Health Services (COS6) *Recruiting*
New Orleans, Louisiana, 70146
United States
Recruiting Madeline Uddo 504-568-0811
Additional Information:
Study ID Numbers: 494;
Study Start Date: July 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032617
Other Stress Disorders, Post-Traumatic Studies:
1. Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder
2. Optimal Treatment Strategies for Sexually Abused Children
3. Treatment of Post Traumatic Stress Disorder in Patients with other Mental Illnesses
4. Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault
5. Clinical Trial of Cognitive Behavioral Treatment for Postraumatic Stress Disorder in Women Veterans
Related Studies:
Other Stress Disorders, Post-Traumatic Clinical Trials
Other Vermont Clinical Trials
Other White River Junction Clinical Trials
Clinical Trial of Cognitive Behavioral Treatment for Postraumatic Stress Disorder in Women Veterans
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