Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault
| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 4, 2003 |
| Last Updated Date | November 6, 2008 |
| Start Date ICMJE | January 2002 |
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Severity of PTSD, depression, anxiety and general function [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00057629 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault |
| Official Title ICMJE | Effectiveness of Treatment for PTSD in Community Agencies |
| Brief Summary | This study will evaluate the effectiveness of a brief cognitive behavioral therapy, administered by community agencies, for the treatment of patients with Post Traumatic Stress Disorder (PTSD). |
| Detailed Description | PE is a brief cognitive behavioral therapy that can ameliorate symptoms of PTSD, depression, and anxiety in survivors of various types of trauma. PE has been successfully implemented by counselors at a community rape crisis clinic (Women Organized Against Rape [WOAR]) who received extensive training and weekly supervision from PE experts. Such extensive expert involvement is not a practical model for long-term clinical practice in a community-based clinic. Therefore, Part 1 of this study will examine whether counselors at WOAR can maintain their PE implementation success with reduced expert involvement. In Part 2 of this study, PE will be implemented by counselors at another community clinic (Joseph J. Peters Institute [JJPI]) to examine its effectiveness in treating PTSD and to determine the generalizability of training procedures. Participants in this study are randomly assigned to either PE or to individual and group therapy. Treatment sessions are conducted weekly for 10 to 20 weeks, based on participants' rates of improvement. Participants are assessed before treatment, after 10 weeks, and again in the follow-up phase at 3, 6, 12, and 24 months post-treatment. |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 Phase 3 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Condition ICMJE | Stress Disorders, Post-Traumatic |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 187 |
| Completion Date | Not Provided |
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female |
| Ages | 18 Years to 67 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00057629 |
| Other Study ID Numbers ICMJE | R01 MH42178, DSIR AT-AS |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Elizabeth Hembree, PhD, Center for the Treatment and Study of Anxiety, University of Pennsylvania |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Verification Date | November 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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