Group Cognitive Processing Therapy for Combat-related Posttraumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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The 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.

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 other forms of group treatment. The public policy implications of the results of this trial are significant. If group treatment is found to be effective, then group treatment would be a more efficient and cost-effective therapy modality in most cases. The 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. One hundred (100) 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 to receive either group PCT or group CPT-C.

Official Title
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Group 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: Group Present Centered Therapy


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 (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.<br>|
| Active Comparator: Group Present Centered Therapy<br> | Behavioral: Group Present Centered Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic 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 |
| --- | --- | --- |
| 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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Posttraumatic Stress Disorder, Cognitive Processing Therapy, combat, military, CPT, group therapy