A Randomized Clinical Trial of Cognitive-Behavioral Treatment for Post-Traumatic Stress Disorders in Women
NCT ID: NCT00032617
Last Updated: 2010-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
284 participants
INTERVENTIONAL
2002-08-31
2006-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Prolonged Exposure
Prolonged Exposure
trauma-focused exposure therapy
2
Present Centered Therapy
Present Centered Therapy
therapy that focuses on current problems
Interventions
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Prolonged Exposure
trauma-focused exposure therapy
Present Centered Therapy
therapy that focuses on current problems
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
Yes
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Department of Veterans Affairs
Principal Investigators
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Matthew J. Friedman, MD PhD
Role: STUDY_CHAIR
VA Medical & Regional Office Center
Locations
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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
Countries
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References
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Stirman SW, Cohen ZD, Lunney CA, DeRubeis RJ, Wiley JF, Schnurr PP. A personalized index to inform selection of a trauma-focused or non-trauma-focused treatment for PTSD. Behav Res Ther. 2021 Jul;142:103872. doi: 10.1016/j.brat.2021.103872. Epub 2021 Apr 26.
Schnurr PP, Lunney CA. Residual symptoms following prolonged exposure and present-centered therapy for PTSD in female veterans and soldiers. Depress Anxiety. 2019 Feb;36(2):162-169. doi: 10.1002/da.22871. Epub 2018 Dec 21.
Lunney CA, Schnurr PP, Cook JM. Comparison of clinician- and self-assessments of posttraumatic stress symptoms in older versus younger veterans. J Trauma Stress. 2014 Apr;27(2):144-51. doi: 10.1002/jts.21908. Epub 2014 Apr 2.
Rosen CS, Greenbaum MA, Schnurr PP, Holmes TH, Brennan PL, Friedman MJ. Do benzodiazepines reduce the effectiveness of exposure therapy for posttraumatic stress disorder? J Clin Psychiatry. 2013 Dec;74(12):1241-8. doi: 10.4088/JCP.13m08592.
Wolf EJ, Lunney CA, Miller MW, Resick PA, Friedman MJ, Schnurr PP. The dissociative subtype of PTSD: a replication and extension. Depress Anxiety. 2012 Aug;29(8):679-88. doi: 10.1002/da.21946. Epub 2012 May 25.
Schnurr PP, Friedman MJ, Engel CC, Foa EB, Shea MT, Chow BK, Resick PA, Thurston V, Orsillo SM, Haug R, Turner C, Bernardy N. Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA. 2007 Feb 28;297(8):820-30. doi: 10.1001/jama.297.8.820.
Other Identifiers
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494
Identifier Type: -
Identifier Source: org_study_id