Cognitive Processing Therapy for Combat-related Posttraumatic Stress Disorder (PTSD)
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| First Received Date ICMJE | January 26, 2011 | ||||
| Last Updated Date | January 27, 2011 | ||||
| Start Date ICMJE | September 2008 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01286415 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cognitive Processing Therapy for Combat-related Posttraumatic Stress Disorder (PTSD) | ||||
| Official Title ICMJE | Cognitive Processing Therapy for Combat-related PTSD | ||||
| Brief Summary | The first purpose of this study is to compare group-administered Cognitive Processing Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format. A second purpose is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel. |
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| Detailed Description | Estimates indicate that between 100,000 and 300,000 Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans are at significant risk for chronic post-traumatic stress disorder (PTSD), which can become a chronic disorder that impacts all areas of a person's life. PTSD treatment programs are being developed throughout the Department of Defense (DoD) and the Veterans Affairs (VA), but because of the large number of Service Members returning from deployment with PTSD, it is often necessary to provide psychotherapy in groups. Cognitive Processing Therapy (CPT), an evidence-based treatment for PTSD, was originally developed as a group-based intervention. However, group-based CPT treatment has never been systematically compared to other forms of group treatment or to individual CPT treatment. The public policy implications of the results of this trial are significant. If both treatment formats are equivalent or if group treatment is better, then group treatment would be a more efficient and cost-effective therapy modality in most cases. On the other hand, if individual therapy is found to be superior, the investment of greater resources into individual therapy will be justified in order to provide the most effective treatment for PTSD to military personnel. The first purpose of this study is to compare group-administered CPT-Cognitive-only version (CPT-C) to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format. A second purpose is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel. Four hundred (400) adult male and female active-duty OIF/OEF military personnel over 18 years of age will be enrolled into this study over the course of five years. Approximately 98 participants will receive either group PCT or group CPT-C; the remainder of the participants will be randomized between group and individual CPT-C. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Posttraumatic Stress Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01286415 | ||||
| Other Study ID Numbers ICMJE | W81XWH-08-2-0116 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Patricia Resick, Ph.D., VA Boston Healthcare System | ||||
| Study Sponsor ICMJE | VA Boston Healthcare System | ||||
| Collaborators ICMJE | STRONG STAR Multidisciplinary Research Consortium | ||||
| Investigators ICMJE |
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| Information Provided By | VA Boston Healthcare System | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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