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

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ClinicalTrials.gov Identifier: NCT01286415
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : March 27, 2017
Sponsor:
Collaborators:
STRONG STAR Multidisciplinary Research Consortium
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
Patricia Resick, Duke University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Group Cognitive Processing Therapy-Cognitive Only Behavioral: Group Present Centered Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Cognitive Processing Therapy for Combat-related PTSD
Study Start Date : September 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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U.S. FDA Resources

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286415


Locations
United States, Texas
Fort Hood Army Base
Fort Hood, Texas, United States, 76544
Sponsors and Collaborators
VA Boston Healthcare System
STRONG STAR Multidisciplinary Research Consortium
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Patricia A Resick, PhD Duke University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: Patricia Resick, Professor, Duke University
ClinicalTrials.gov Identifier: NCT01286415     History of Changes
Other Study ID Numbers: W81XWH-08-2-0116
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

Keywords provided by Patricia Resick, Duke University:
Posttraumatic Stress Disorder
Cognitive Processing Therapy
combat
 military
CPT
group therapy

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders