Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault

Phase 2

Completed

• Conditions: Stress Disorders, Post-Traumatic

• Registration Number: NCT00057629
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study Start: 2002-01
• Study First Submitted: 2003-04-04
• Study First Submitted QC: 2003-04-04
• Study First Posted: 2003-04-08
• Primary Completion: 2008-08
• Study Completion: 2009-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-12
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severity of PTSD, depression, anxiety and general function	Measured pre- and post-treatment

Trial Locations

Locations (2)

Center for the Treatment and Study of Anxiety, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Women Organized Against Rape (WOAR); 🇺🇸 Philadelphia, Pennsylvania, United States