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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Cognitive Processes in PTSD: Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239772
• Other study ID #: R01MH051509-05
• Secondary ID: R01MH051509-05DS
• Status: Completed
• Phase: N/A
• First received: October 13, 2005
• Last updated: June 4, 2014
• Start date: May 1994

Study information

• Verified date: June 2014
• 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 prolonged exposure therapy in treating women with post-traumatic stress disorder (PTSD) 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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 Processing Therapy

• Prolonged Exposure Therapy

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	Post-traumatic stress disorder symptoms; measured immediately post-treatment and at 3, 6, and 9 months post-treatment
Secondary	Feelings of guilt and shame; measured immediately post-treatment and at 3, 6, and 9 months post-treatment
Secondary	Overall perception of self and surroundings; measured immediately post-treatment and at 3, 6, and 9 months post-treatment