Clinical trial NCT00057629: Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault
Official title: Effectiveness of Treatment for PTSD in Community Agencies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stress Disorders, Post-Traumatic
Keywords: Rape
Sex Offenses
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-04-08
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Severity of PTSD, depression, anxiety and general function
timeFrame: Measured pre- and post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for the Treatment and Study of Anxiety, University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Women Organized Against Rape (WOAR)
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania Faculty
name: Elizabeth A Hembree, PhD
role: PRINCIPAL_INVESTIGATOR
References: