Group Treatment for PTSD: A Randomized Clinical Trial With Veterans
GCBT
Group CBT for Chronic PTSD: RCT With Veterans
2 other identifiers
interventional
198
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedResults Posted
Study results publicly available
April 29, 2019
CompletedMarch 23, 2020
March 1, 2020
5.1 years
February 28, 2012
June 13, 2018
March 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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 Outcomes (3)
Beck Depression Inventory, II (BDI-II)
12 months
Short-Form Health Survey (SF-36)
12 months
Beck Anxiety Inventory (BAI)
12 months
Study Arms (2)
Arm 1: GCBT
EXPERIMENTALGroup Cognitive Behavioral treatment (GCBT)
Arm 2: Group Treatment
ACTIVE COMPARATORPresent Centered Group Treatment
Interventions
GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- a current diagnosis of substance dependence or unstable bipolar disorder
- currently involved in psychosocial treatment for PTSD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130, United States
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908, United States
Related Publications (3)
Sloan DM, Unger W, Lee DJ, Beck JG. A Randomized Controlled Trial of Group Cognitive Behavioral Treatment for Veterans Diagnosed With Chronic Posttraumatic Stress Disorder. J Trauma Stress. 2018 Dec;31(6):886-898. doi: 10.1002/jts.22338. Epub 2018 Nov 29.
PMID: 30499227BACKGROUNDSloan DM, Unger W, Gayle Beck J. Cognitive-behavioral group treatment for veterans diagnosed with PTSD: Design of a hybrid efficacy-effectiveness clinical trial. Contemp Clin Trials. 2016 Mar;47:123-30. doi: 10.1016/j.cct.2015.12.016. Epub 2015 Dec 21.
PMID: 26718094BACKGROUNDMarx BP, Lee DJ, Norman SB, Bovin MJ, Sloan DM, Weathers FW, Keane TM, Schnurr PP. Reliable and clinically significant change in the clinician-administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 among male veterans. Psychol Assess. 2022 Feb;34(2):197-203. doi: 10.1037/pas0001098. Epub 2021 Dec 23.
PMID: 34941354DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No women veterans were included in the study, therefore findings are not generalizable to women veterans.
Results Point of Contact
- Title
- Denise Sloan, Ph.D.
- Organization
- VA Boston Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Denise M Sloan, PhD
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2012
First Posted
March 5, 2012
Study Start
July 1, 2012
Primary Completion
August 23, 2017
Study Completion
June 1, 2018
Last Updated
March 23, 2020
Results First Posted
April 29, 2019
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
Data will be made available through Freedom of Information Act.