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

This study is currently recruiting participants.
Verified February 2014 by VA Boston Healthcare System
Sponsor:
Collaborator:
STRONG STAR Multidisciplinary Research Consortium
Information provided by (Responsible Party):
Patricia Resick, Duke University
ClinicalTrials.gov Identifier:
NCT01286415
First received: January 26, 2011
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

The first 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. A second purpose is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel.


Condition Intervention
Posttraumatic Stress Disorder
Behavioral: Group Cognitive Processing Therapy
Behavioral: Group Present Centered Therapy
Behavioral: Individual Cognitive Processing Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Processing Therapy for Combat-related PTSD

Resource links provided by NLM:


Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    PCL-S measures symptoms of posttraumatic stress disorder in response to a specific stressor.

  • Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: Once per week for 6 weeks during receipt of the study treatment ] [ Designated as safety issue: No ]
  • Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: 2 weeks posttreatment ] [ Designated as safety issue: No ]
  • Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: 6 months posttreament ] [ Designated as safety issue: No ]
  • Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) [ Time Frame: 12 months posttreament ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Cognitive Processing Therapy Behavioral: Group Cognitive Processing Therapy
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.
Experimental: Individual Cognitive Processing Therapy Behavioral: Individual Cognitive Processing Therapy
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 6 weeks; sessions are 60 minutes.

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 or 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 first 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. A second purpose is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel. Four hundred (400) adult male and female active-duty OIF/OEF military personnel over 18 years of age will be enrolled into this study over the course of five years. Approximately 98 participants will receive either group PCT or group CPT-C; the remainder of the participants will be randomized between group and individual CPT-C.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286415

Contacts
Contact: Elisa Borah, MSW, PhD 512-639-8989 Borah@uthscsa.edu

Locations
United States, Texas
Fort Hood Army Base Recruiting
Fort Hood, Texas, United States, 76544
Contact: Elisa Borah, PhD    254-432-4169    borah@uthscsa.edu   
Principal Investigator: Adam Borah, MD         
Sponsors and Collaborators
University of Texas Health Sciences Center San Antonio
STRONG STAR Multidisciplinary Research Consortium
Investigators
Principal Investigator: Patricia A Resick, PhD National Center for PTSD, VA Boston Healthcare System
  More Information

No publications provided

Responsible Party: Patricia Resick, Professor, Duke University
ClinicalTrials.gov Identifier: NCT01286415     History of Changes
Other Study ID Numbers: W81XWH-08-2-0116
Study First Received: January 26, 2011
Last Updated: February 12, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by VA Boston Healthcare System:
Posttraumatic Stress Disorder
Cognitive Processing Therapy
combat
military
CPT
group therapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014