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Completed

NCT Number: NCT02173561

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fort Hood Army Base

Fort Hood, Texas, 76544, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Group Cognitive Processing Therapy-Cognitive Only

Behavioral

Cognitive Processing Therapy-Cognitive Only version (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT-C 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 in groups of 8-12 participants. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.

Other names: Group CPT-C

Individual Cognitive Processing Therapy-Cognitive Only

Behavioral

Cognitive Processing Therapy-Cognitive Only (CPT-C) 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. Individual sessions will be conducted twice weekly for six weeks; each session is 60 minutes.

Other names: Individual CPT-C

Primary outcomes

  1. Change from baseline in PTSD symptoms as measured by thePosttraumatic 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 outcomes

  1. Change from baseline in depressive symptoms as measured by the 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • STRONG STAR Consortium
  • The University of Texas Health Science Center at San Antonio
  • VA Boston Healthcare System

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2014
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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