Cognitive Processing Therapy Versus Its Individual Components in the Treatment of Post-Traumatic Stress Disorder and Depression in Women Who Have Been Sexually Abused

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00245232
First received: October 25, 2005
Last updated: September 19, 2008
Last verified: September 2008
  Purpose

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.


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

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 National Institute of Mental Health (NIMH):

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

Estimated Enrollment: 228
Study Start Date: August 2000
Estimated Study Completion Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00245232

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

Publications:
ClinicalTrials.gov Identifier: NCT00245232     History of Changes
Other Study ID Numbers: R01 MH51509-06, DSIR AT-AS
Study First Received: October 25, 2005
Last Updated: September 19, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
PTSD
Cognitive therapy
Rape

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

ClinicalTrials.gov processed this record on September 18, 2014