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Clinical Trials/NCT00057629
NCT00057629
Completed
Phase 2

Effectiveness of Treatment for PTSD in Community Agencies

University of Pennsylvania2 sites in 1 country187 target enrollmentJanuary 2002

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stress Disorders, Post-Traumatic
Sponsor
University of Pennsylvania
Enrollment
187
Locations
2
Primary Endpoint
Severity of PTSD, depression, anxiety and general function
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2002
End Date
August 2009
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • DSM-IV criteria for PTSD at least 12 weeks after sexual assault
  • PTSD symptoms that result from sexual assault and not from another traumatic experience

Exclusion Criteria

  • DSM-IV criteria for schizophrenia or delusional disorder
  • Unstable bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment. Clients who are medicated and still meet current criteria for these disorders will be excluded.
  • Substance dependence
  • Continued intimate relationship with the assailant

Outcomes

Primary Outcomes

Severity of PTSD, depression, anxiety and general function

Time Frame: Measured pre- and post-treatment

Study Sites (2)

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