Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01544088
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : April 29, 2019
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
PTSD Behavioral: Group Cognitive Behavioral Treatment (GCBT) Behavioral: Present Centered Group Treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group CBT for Chronic PTSD: RCT With Veterans
Actual Study Start Date : July 1, 2012
Actual Primary Completion Date : August 23, 2017
Actual Study Completion Date : June 1, 2018

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544088


Locations
Layout table for location information
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
Investigators
Layout table for investigator information
Principal Investigator: Denise M Sloan, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Publications:
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01544088    
Other Study ID Numbers: MHBA-015-11F
1I01CX000467-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2012    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available through Freedom of Information Act.

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
randomized controlled trial
PTSD
cognitive behavioral treatment
group treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders