Cognitive Processing Therapy for Combat-related Posttraumatic Stress Disorder (PTSD)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Posttraumatic Stress Disorder |
Behavioral: Group Cognitive Processing Therapy Behavioral: Group Present Centered Therapy Behavioral: Individual Cognitive Processing Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cognitive Processing Therapy for Combat-related PTSD |
- Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: Baseline ] [ Designated as safety issue: No ]PCL-S measures symptoms of posttraumatic stress disorder in response to a specific stressor.
- Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: Once per week for 6 weeks during receipt of the study treatment ] [ Designated as safety issue: No ]
- Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: 2 weeks posttreatment ] [ Designated as safety issue: No ]
- Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: 6 months posttreament ] [ Designated as safety issue: No ]
- Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: 12 months posttreament ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group Cognitive Processing Therapy |
Behavioral: Group Cognitive Processing Therapy
Cognitive Processing Therapy (CPT) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.
|
| Active Comparator: Group Present Centered Therapy |
Behavioral: Group Present Centered Therapy
Present Centered Therapy (PCT) is a supportive group intervention typically used within the Department of Veterans Affairs (VA) healthcare systems to address problems of veterans with PTSD (Rosen, et al., 2004). PCT focuses on problem-solving current difficulties that may be related to past traumatic events, but does not address specific memories or cognitions about the trauma. Sessions will be conducted twice weekly for 6 weeks; sessions are 90 minutes.
|
| Experimental: Individual Cognitive Processing Therapy |
Behavioral: Individual Cognitive Processing Therapy
Cognitive Processing Therapy (CPT) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Sessions will be conducted twice weekly for 6 weeks; sessions are 60 minutes.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult male and female active duty, activated Reservist, or activated National Guard OIF/OEF military personnel or OIF/OEF veterans seeking treatment for PTSD
- diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSSI)
- person has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of OIF/OEF. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
- be over the age of 18
- speak and read English
- be stable on any psychotropic medications they may be taking.
Exclusion Criteria:
- current suicide or homicide risk meriting crisis intervention
- active psychosis
- moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires)
Contacts and Locations| Contact: Elisa Borah, MSW, PhD | 512-639-8989 | Borah@uthscsa.edu |
| United States, Texas | |
| Fort Hood Army Base | Recruiting |
| Fort Hood, Texas, United States, 76544 | |
| Contact: Elisa Borah, PhD 254-432-4169 borah@uthscsa.edu | |
| Principal Investigator: Jennifer McClure, PhD | |
| Principal Investigator: | Patricia A Resick, PhD | National Center for PTSD, VA Boston Healthcare System |
More Information
No publications provided
| Responsible Party: | Patricia Resick, Ph.D., VA Boston Healthcare System |
| ClinicalTrials.gov Identifier: | NCT01286415 History of Changes |
| Other Study ID Numbers: | W81XWH-08-2-0116 |
| Study First Received: | January 26, 2011 |
| Last Updated: | January 27, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by VA Boston Healthcare System:
|
Posttraumatic Stress Disorder Cognitive Processing Therapy combat |
military CPT group therapy |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013