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Tracking Information | |||||
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First Received Date † | October 13, 2005 | ||||
Last Updated Date | September 19, 2008 | ||||
Start Date † | May 1994 | ||||
Current Primary Outcome Measures † |
Post-traumatic stress disorder symptoms; measured immediately post-treatment and at 3, 6, and 9 months post-treatment | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00239772 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Cognitive Processing Therapy Versus Prolonged Exposure for Treating Women With Post-Traumatic Stress Disorder Brought on by Sexual Assault | ||||
Official Title † | Cognitive Processes in PTSD: Treatment | ||||
Brief 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. |
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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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Post-Traumatic Stress Disorder | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | 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. 2002 Aug;70(4):867-79. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 120 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00239772 | ||||
Responsible Party | |||||
Secondary IDs †† | DSIR AT-AS | ||||
Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Institute of Mental Health (NIMH) | ||||
Verification Date | September 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |