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Group CBT for PTSD (GCBT)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: February 28, 2012
Last updated: December 5, 2016
Last verified: December 2016
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.

Condition Intervention Phase
Behavioral: Group Cognitive Behavioral Treatment (GCBT)
Behavioral: Present Centered Group Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group CBT for Chronic PTSD: RCT With Veterans

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 12 months ]
    The CAPS 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.

Secondary Outcome Measures:
  • Beck Depression Inventory, II (BDI-II) [ Time Frame: 12 months ]
    The BDI is a self-report inventory that indexes depression symptom severity.

  • Short-Form Health Survey (SF-36) [ Time Frame: 12 months ]
    The SF-36 is a measure of functional impairment.

  • Short Index of Problems (SIP) [ Time Frame: 12 months ]
    The SIP is a self-report measure of alcohol use and alcohol-related problems.

  • Beck Anxiety Inventory (BAI) [ Time Frame: 12 months ]
    The BAI is a self-report measure of general anxiety symptom severity.

Estimated Enrollment: 196
Study Start Date: July 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01544088

United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Denise M Sloan, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT01544088     History of Changes
Other Study ID Numbers: MHBA-015-11F
1I01CX000467-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: February 28, 2012
Last Updated: December 5, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data will be made available through Freedom of Information Act.

Keywords provided by VA Office of Research and Development:
randomized controlled trial
cognitive behavioral treatment
group treatment processed this record on April 21, 2017