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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Cognitive Processes in PTSD: Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245232
• Other study ID #: R01MH051509-06
• Secondary ID: R01MH051509-06DS
• Status: Completed
• Phase: N/A
• First received: October 25, 2005
• Last updated: March 30, 2015
• Start date: August 2000
• Est. completion date: April 2005

Study information

• Verified date: March 2015
• Source: University of Missouri, St. Louis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Therapy

• Cognitive Processing Therapy

• Written Exposure

Locations

Country	Name	City	State
United States	Center for Trauma and Recovery, University of Missouri - St. Louis	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri, St. Louis	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression symptoms; measured immediately post-treatment and 6 months post-treatment
Primary	Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment