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Completed

NCT Number: NCT00239772

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Trauma and Recovery, University of Missouri - St. Louis

St Louis, Missouri, 63121-4499, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive processing therapy

Behavioral

Prolonged Exposure Therapy

Behavioral

Primary outcomes

  1. Post-traumatic stress disorder symptoms; measured immediately post-treatment and at 3, 6, and 9 months post-treatment

Secondary outcomes

  1. Feelings of guilt and shame; measured immediately post-treatment and at 3, 6, and 9 months post-treatment

  2. Overall perception of self and surroundings; measured immediately post-treatment and at 3, 6, and 9 months post-treatment

Sponsors and collaborators

Lead sponsor

University of Missouri, St. Louis

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Cognitive Processes in PTSD: Treatment

Important dates

Study start
1994
First posted
Oct 17, 2005
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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