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Cognitive Processing Therapy Versus Prolonged Exposure for Treating Women With Post-Traumatic Stress Disorder Brought on by Sexual Assault

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy
Prolonged Exposure Therapy
Sponsored by
University of Missouri, St. Louis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Cognitive Therapy, PTSD, Females, Rape, Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: History of at least one incidence of rape Diagnosed with post-traumatic stress disorder Exclusion Criteria: Rape occurred before the age of 13 and was committed by a family member Rape was committed by a spouse who is currently living in the same household Psychosis Mental retardation Current pathology that may complicate symptoms of post-traumatic stress disorder Currently suicidal or parasuicidal Currently addicted to drugs or alcohol Illiterate

Sites / Locations

  • Center for Trauma and Recovery, University of Missouri - St. Louis

Outcomes

Primary Outcome Measures

Post-traumatic stress disorder symptoms; measured immediately post-treatment and at 3, 6, and 9 months post-treatment

Secondary Outcome Measures

Feelings of guilt and shame; measured immediately post-treatment and at 3, 6, and 9 months post-treatment
Overall perception of self and surroundings; measured immediately post-treatment and at 3, 6, and 9 months post-treatment

Full Information

First Posted
October 13, 2005
Last Updated
June 4, 2014
Sponsor
University of Missouri, St. Louis
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00239772
Brief Title
Cognitive Processing Therapy Versus Prolonged Exposure for Treating Women With Post-Traumatic Stress Disorder Brought on by Sexual Assault
Official Title
Cognitive Processes in PTSD: Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Missouri, St. Louis
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the effectiveness of cognitive processing therapy versus prolonged exposure therapy in treating women with post-traumatic stress disorder (PTSD) brought on by sexual assault.
Detailed Description
PTSD is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will evaluate the effectiveness of cognitive processing therapy (CPT) versus prolonged exposure therapy in treating women with PTSD brought on by sexual assault. Participants in this single-blind study will be randomly assigned to one of three conditions: CPT, prolonged exposure therapy (PE), or minimal attention (MA). Individuals assigned to receive CPT will attend therapy sessions twice weekly for 6 weeks. Each session will be 1 hour long, except for sessions 4 and 5, which will be 1.5 hours long. CPT will focus on helping each individual to process accurate memories of the traumatic event and to work through any memories that cannot be completely ignored, nor completely integrated back into their thinking. Also included in CPT will be an exposure component, in which participants will be encouraged to recall the traumatic event and experience any emotions connected to it. Participants assigned to receive PE therapy will attend an initial 1-hour therapy session, followed by 4 weeks of additional sessions that will meet twice weekly. Each of these 8 sessions will be 1.5 hours long. PE will entail oral exposure without modification of the participant's cognitions. Participants will discuss their traumatic experiences in detail during each session to aid in emotional processing. All PE sessions will be audio taped. Participants will listen to the tapes of their sessions on their own to further assist with emotional processing. Individuals assigned to receive MA will receive no therapy for the first 6 weeks. At the end of this initial phase, they will be assigned to receive either CPT or PE if they still meet diagnostic criteria for PTSD. Symptoms of PTSD, feelings of guilt and shame, and overall perception of self and surroundings will be assessed at baseline, post-treatment, and at follow-up visits at 3, 6, and 9 months post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Cognitive Therapy, PTSD, Females, Rape, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Primary Outcome Measure Information:
Title
Post-traumatic stress disorder symptoms; measured immediately post-treatment and at 3, 6, and 9 months post-treatment
Secondary Outcome Measure Information:
Title
Feelings of guilt and shame; measured immediately post-treatment and at 3, 6, and 9 months post-treatment
Title
Overall perception of self and surroundings; measured immediately post-treatment and at 3, 6, and 9 months post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of at least one incidence of rape Diagnosed with post-traumatic stress disorder Exclusion Criteria: Rape occurred before the age of 13 and was committed by a family member Rape was committed by a spouse who is currently living in the same household Psychosis Mental retardation Current pathology that may complicate symptoms of post-traumatic stress disorder Currently suicidal or parasuicidal Currently addicted to drugs or alcohol Illiterate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia A. Resick, PhD
Organizational Affiliation
National Center for PTSD, Women's Health Sciences Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Trauma and Recovery, University of Missouri - St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63121-4499
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12182270
Citation
Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.
Results Reference
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Cognitive Processing Therapy Versus Prolonged Exposure for Treating Women With Post-Traumatic Stress Disorder Brought on by Sexual Assault

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