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

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: Group Cognitive Processing Therapy-Cognitive Only; Behavioral: Individual Cognitive Processing Therapy-Cognitive Only

• Registration Number: NCT02173561
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Cognitive Processing Therapy-Cognitive Only	Group Cognitive Processing Therapy-Cognitive Only	-
Individual Cognitive Processing Therapy-Cognitive Only	Individual Cognitive Processing Therapy-Cognitive Only	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in depressive symptoms as measured by the Beck Depression Inventory-II	Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up	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.

Trial Locations

Locations (1)

Fort Hood Army Base; 🇺🇸 Fort Hood, Texas, United States