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

March 22, 2017 updated by: Patricia Resick, VA Boston Healthcare System

Group Cognitive Processing Therapy for Combat-related PTSD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. 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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Hood, Texas, United States, 76544
        • Fort Hood Army Base

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Cognitive Processing Therapy-Cognitive Only
Behavioral: Group Cognitive Processing Therapy-Cognitive Only
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S)
Time Frame: 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.
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
Time Frame: 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.
Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Boston Healthcare System

Collaborators

The University of Texas Health Science Center at San Antonio
STRONG STAR Multidisciplinary Research Consortium

Investigators

  • Principal Investigator: Patricia A Resick, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-08-2-0116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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