Cognitive Processing Therapy Versus Its Individual Components in the Treatment of Post-Traumatic Stress Disorder and Depression in Women Who Have Been Sexually Abused
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Therapy
Cognitive Processing Therapy
Written Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Cognitive therapy, Rape
Eligibility Criteria
Inclusion Criteria: History of a discrete episode of assault in childhood or adulthood Meets criteria for post-traumatic stress disorder Exclusion Criteria: Experienced a traumatic event that was in the form of chronic ongoing abuse and not a discrete incidence Psychosis Mental retardation Suicidal or parasuicidal Currently addicted to drugs Illiterate Currently in an abusive relationship Currently being stalked
Sites / Locations
- Center for Trauma and Recovery, University of Missouri - St. Louis
Outcomes
Primary Outcome Measures
Depression symptoms; measured immediately post-treatment and 6 months post-treatment
Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00245232
First Posted
October 25, 2005
Last Updated
March 30, 2015
Sponsor
University of Missouri, St. Louis
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00245232
Brief Title
Cognitive Processing Therapy Versus Its Individual Components in the Treatment of Post-Traumatic Stress Disorder and Depression in Women Who Have Been Sexually Abused
Official Title
Cognitive Processes in PTSD: Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (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 its individual components in treating women with post-traumatic stress disorder (PTSD) and depression 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 versus its individual components in treating women with post-traumatic stress disorder and depression brought on by sexual assault.
Participants in this single-blind study will be randomly assigned to receive one of three treatments: cognitive processing therapy (CPT); cognitive therapy (CT); or written exposure (WE). Participants assigned to receive either CPT or CT will attend therapy sessions twice weekly for 6 weeks. 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 a WE component, in which participants will be encouraged to recall the traumatic event and experience any emotions connected to it. CT will be similar to CPT, but will not include the WE component. Participants assigned to receive only WE will attend one 2-hour session each week. Symptoms of PTSD and depression will be measured at baseline, post-treatment, and at a 6-month follow-up visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Cognitive therapy, Rape
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
228 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Intervention Type
Behavioral
Intervention Name(s)
Written Exposure
Primary Outcome Measure Information:
Title
Depression symptoms; measured immediately post-treatment and 6 months post-treatment
Title
Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of a discrete episode of assault in childhood or adulthood
Meets criteria for post-traumatic stress disorder
Exclusion Criteria:
Experienced a traumatic event that was in the form of chronic ongoing abuse and not a discrete incidence
Psychosis
Mental retardation
Suicidal or parasuicidal
Currently addicted to drugs
Illiterate
Currently in an abusive relationship
Currently being stalked
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
result
Learn more about this trial
Cognitive Processing Therapy Versus Its Individual Components in the Treatment of Post-Traumatic Stress Disorder and Depression in Women Who Have Been Sexually Abused
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