Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD

Study Overview
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Brief Summary
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The purpose of this study is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel.

Detailed Description
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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 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 purpose of this study is to compare group-administered CPT-Cognitive-only version (CPT-C) to individual CPT-C for the treatment of PTSD in OIF/OEF military personnel. Three hundred (300) adult male and female active-duty OIF/OEF military personnel over 18 years of age will be enrolled into this study. Participants will be randomized between group and individual CPT-C.

Official Title
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Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Group Cognitive Processing Therapy-Cognitive Only
* Behavioral: Individual Cognitive Processing Therapy-Cognitive Only


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Cognitive Processing Therapy-Cognitive Only<br> | Behavioral: Group Cognitive Processing Therapy-Cognitive Only<br>* Cognitive Processing Therapy-Cognitive Only version (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT-C 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 in groups of 8-12 participants. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.<br>* Other names: Group CPT-C;|
| Experimental: Individual Cognitive Processing Therapy-Cognitive Only<br> | Behavioral: Individual Cognitive Processing Therapy-Cognitive Only<br>* Cognitive Processing Therapy-Cognitive Only (CPT-C) 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. Individual sessions will be conducted twice weekly for six weeks; each session is 60 minutes.<br>* Other names: Individual CPT-C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) | PCL-S measures symptoms of posttraumatic stress disorder in response to a specific stressor. | Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms as measured by the Beck Depression Inventory-II | The BDI-II is one of the most widely used instruments for measuring the severity of depressive symptoms. It consists of 21 items that assess both affective and somatic symptoms related to depression and depressive disorders. Each item is composed of four statements that reflect symptom severity. The statements are scaled from 0 (no disturbance) to 3 (maximal disturbance). Scores on all items are summed to obtain a total severity score. | Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Processing Therapy, military, CPT, group therapy, Posttraumatic Stress Disorder, combat