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

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 (submitted: November 3, 2008)	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	Same as current
Change History	Complete list of historical versions of study NCT00057629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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 Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Stress Disorders, Post-Traumatic
Intervention ^ICMJE	Procedure: Prolonged Exposure Therapy Behavioral: Treatment as usual group therapy (TUGT) Behavioral: Supportive counseling group (SC)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	187
Completion Date
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
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 ID ^ICMJE	NCT00057629
Responsible Party	Elizabeth Hembree, PhD, Center for the Treatment and Study of Anxiety, University of Pennsylvania
Study ID Numbers ^ICMJE	R01 MH42178, DSIR AT-AS
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP