Group Treatment for PTSD: A Randomized Clinical Trial With Veterans (GCBT)

March 19, 2020 updated by: VA Office of Research and Development

Group CBT for Chronic PTSD: RCT With Veterans

The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT) is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group treatment condition. Both treatments will consist of 14, weekly sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and 3-, 6-, - and 12-month follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The mental health needs of Veterans within the VA Healthcare system are notable. With the substantial increase over the past 10 years in Veterans seeking Posttraumatic Stress Disorder (PTSD) treatment services, the VA system is straining to accommodate these needs, relying heavily on group-based treatments. The proposed research will take the next step in the literature on group psychotherapy for PTSD by examining a group cognitive behavioral treatment (GCBT) program with promising pilot data. This application supports a randomized controlled trial, which will compare GCBT with Supportive Group Psychotherapy (SGP). The trial will involve 196 male Veterans with combat-related PTSD who will be randomly assigned to GCBT (n= 98) or SGP (n =98) to determine efficacy within a naturalistic care environment. Outcome data will be collected pre-treatment, mid-treatment, post-treatment, and 3-, 6- and 12-month follow-up. Two aims are included, one focusing on outcome with respect to PTSD symptom severity, the second focusing on treatment generalization to comorbid emotional disorders (major depressive disorder, generalized anxiety disorder, and alcohol abuse), and distress and impairment. Data will be examined using latent growth curve modeling, with emphasis on determining efficacy and effectiveness. The information provided by the proposed project could assist in developing more effective care models for individuals with chronic PTSD from numerous traumatic experiences. Additionally, this project represents an effort to move the literature on group-based treatments for PTSD ahead, through inclusion of advanced methodological and analytic approaches.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Providence VA Medical Center, Providence, RI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • primary diagnosis of DSM-IV (American Psychiatric Association, 2000) criteria for chronic, PTSD (symptoms lasting 3 months or more)
  • male, Veteran
  • be free of psychosis and impaired cognitive function caused by traumatic brain injury or dementia

Exclusion Criteria:

  • a current diagnosis of substance dependence or unstable bipolar disorder
  • currently involved in psychosocial treatment for PTSD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: GCBT
Group Cognitive Behavioral treatment (GCBT)
Behavioral: Group Cognitive Behavioral Treatment (GCBT)
GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
Active Comparator: Arm 2: Group Treatment
Present Centered Group Treatment
Behavioral: Present Centered Group Treatment
The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: 12 months
The CAPS-5 is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study. Total score range = 0-80; higher scores indicate greater symptom severity.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory, II (BDI-II)
Time Frame: 12 months
The BDI is a self-report inventory that indexes depression symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
12 months
Short-Form Health Survey (SF-36)
Time Frame: 12 months
The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning.
12 months
Beck Anxiety Inventory (BAI)
Time Frame: 12 months
The BAI is a self-report measure of general anxiety symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Denise M Sloan, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

August 23, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHBA-015-11F
  • 1I01CX000467-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available through Freedom of Information Act.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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