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

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Duke University

Status

Completed

Conditions

Posttraumatic Stress Disorder

Treatments

Behavioral: Individual Cognitive Processing Therapy-Cognitive Only
Behavioral: Group Cognitive Processing Therapy-Cognitive Only

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02173561
W81XWH-08-2-0116-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups

Group Cognitive Processing Therapy-Cognitive Only
Experimental group
Treatment:
Behavioral: Group Cognitive Processing Therapy-Cognitive Only
Individual Cognitive Processing Therapy-Cognitive Only
Experimental group
Treatment:
Behavioral: Individual Cognitive Processing Therapy-Cognitive Only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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