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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Missouri, St. Louis
ClinicalTrials.gov Identifier:
NCT00239772
First received: October 13, 2005
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Post-Traumatic Stress Disorder
Behavioral: Cognitive Processing Therapy
Behavioral: Prolonged Exposure Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Cognitive Processes in PTSD: Treatment

Resource links provided by NLM:


Further study details as provided by University of Missouri, St. Louis:

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

Estimated Enrollment: 120
Study Start Date: May 1994
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239772

Locations
United States, Missouri
Center for Trauma and Recovery, University of Missouri - St. Louis
St. Louis, Missouri, United States, 63121-4499
Sponsors and Collaborators
University of Missouri, St. Louis
Investigators
Principal Investigator: Patricia A. Resick, PhD National Center for PTSD, Women's Health Sciences Division
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00239772     History of Changes
Other Study ID Numbers: R01 MH51509-05, R01MH051509-05, DSIR AT-AS
Study First Received: October 13, 2005
Last Updated: June 4, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Missouri, St. Louis:
Cognitive Therapy
PTSD
Females
Rape
Trauma

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Disease
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014