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

January 26, 2011
February 12, 2014
September 2008
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01286415 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cognitive Processing Therapy for Combat-related Posttraumatic Stress Disorder (PTSD)
Cognitive Processing Therapy for Combat-related PTSD

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
  • 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.
  • 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.
  • 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.
  • Experimental: Group Cognitive Processing Therapy
    Intervention: Behavioral: Group Cognitive Processing Therapy
  • Active Comparator: Group Present Centered Therapy
    Intervention: Behavioral: Group Present Centered Therapy
  • Experimental: Individual Cognitive Processing Therapy
    Intervention: Behavioral: Individual Cognitive Processing Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2014
December 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Elisa Borah, MSW, PhD 512-639-8989 Borah@uthscsa.edu
United States
 
NCT01286415
W81XWH-08-2-0116
Yes
Patricia Resick, Duke University
University of Texas Health Sciences Center San Antonio
STRONG STAR Multidisciplinary Research Consortium
Principal Investigator: Patricia A Resick, PhD National Center for PTSD, VA Boston Healthcare System
VA Boston Healthcare System
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP