Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00057629

Purpose

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).

Condition	Intervention	Phase
Stress Disorders, Post-Traumatic	Procedure: Prolonged Exposure Therapy Behavioral: Treatment as usual group therapy (TUGT) Behavioral: Supportive counseling group (SC)	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of Treatment for PTSD in Community Agencies

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder Rape

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Severity of PTSD, depression, anxiety and general function [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ]

Enrollment:	187
Study Start Date:	January 2002
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Prolonged Exposure: Experimental	Procedure: Prolonged Exposure Therapy 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: Active Comparator	Behavioral: Treatment as usual group therapy (TUGT) TUGT is delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is not a formal, structured format for these groups; the counselors are sensitive to the participants' needs and follow their lead in terms of content covered in discussions and exercises. TUGT is conceptualized as supportive counseling and is based on the idea that members gain social support and information from one another. Behavioral: Supportive counseling group (SC) Supportive counseling is an individual therapy delivered in 10 weekly, 90 minute sessions. During this treatment, the therapist helps the 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 therapist uses active listening, encouragement of expression of feelings, praise, and encouragement. 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. No instructions for exposure are given.

Arms

Assigned Interventions

1 Prolonged Exposure: Experimental

Procedure: Prolonged Exposure Therapy

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: Active Comparator

Behavioral: Treatment as usual group therapy (TUGT)

TUGT is delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is not a formal, structured format for these groups; the counselors are sensitive to the participants' needs and follow their lead in terms of content covered in discussions and exercises. TUGT is conceptualized as supportive counseling and is based on the idea that members gain social support and information from one another.

Behavioral: Supportive counseling group (SC)

Supportive counseling is an individual therapy delivered in 10 weekly, 90 minute sessions. During this treatment, the therapist helps the 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 therapist uses active listening, encouragement of expression of feelings, praise, and encouragement. 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. No instructions for exposure are given.

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.

Eligibility

Ages Eligible for Study:	18 Years to 67 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057629

Locations

United States, Pennsylvania
Center for the Treatment and Study of Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Women Organized Against Rape (WOAR)
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

No publications provided

Responsible Party:	Center for the Treatment and Study of Anxiety, University of Pennsylvania ( Elizabeth Hembree, PhD )
Study ID Numbers:	R01 MH42178, DSIR AT-AS
Study First Received:	April 4, 2003
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00057629 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Rape
Sex Offenses

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on November 25, 2009