Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault

Phase 2

Completed

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Behavioral: Prolonged Exposure (PE); Behavioral: Treatment as usual group therapy (TUGT); Behavioral: Supportive counseling (SC)

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Prolonged Exposure	Prolonged Exposure (PE)	Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.
2 Individual and group therapy	Supportive counseling (SC)	TUGT (Treatment as usual group therapy - used in Study 1), delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is no formal, structured format for these groups; counselors are sensitive to the participants' needs and follow their lead re content covered in discussions and exercises. Supportive counseling (SC - study 2): individual therapy delivered in 10 weekly, 90 minute sessions. Therapist helps patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these.
2 Individual and group therapy	Treatment as usual group therapy (TUGT)	TUGT (Treatment as usual group therapy - used in Study 1), delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is no formal, structured format for these groups; counselors are sensitive to the participants' needs and follow their lead re content covered in discussions and exercises. Supportive counseling (SC - study 2): individual therapy delivered in 10 weekly, 90 minute sessions. Therapist helps patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these.

Primary Outcome Measures

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

Trial Locations

Locations (2)

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

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