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

Primary Purpose

PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Cognitive Behavioral Treatment (GCBT)
Present Centered Group Treatment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring randomized controlled trial, PTSD, cognitive behavioral treatment, group treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • Providence VA Medical Center, Providence, RI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: GCBT

Arm 2: Group Treatment

Arm Description

Group Cognitive Behavioral treatment (GCBT)

Present Centered Group Treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2012
Last Updated
March 19, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01544088
Brief Title
Group Treatment for PTSD: A Randomized Clinical Trial With Veterans
Acronym
GCBT
Official Title
Group CBT for Chronic PTSD: RCT With Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2012 (Actual)
Primary Completion Date
August 23, 2017 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
randomized controlled trial, PTSD, cognitive behavioral treatment, group treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: GCBT
Arm Type
Experimental
Arm Description
Group Cognitive Behavioral treatment (GCBT)
Arm Title
Arm 2: Group Treatment
Arm Type
Active Comparator
Arm Description
Present Centered Group Treatment
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Behavioral Treatment (GCBT)
Intervention Description
GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
Intervention Type
Behavioral
Intervention Name(s)
Present Centered Group Treatment
Intervention Description
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 Measure Information:
Title
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Beck Depression Inventory, II (BDI-II)
Description
The BDI is a self-report inventory that indexes depression symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Time Frame
12 months
Title
Short-Form Health Survey (SF-36)
Description
The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning.
Time Frame
12 months
Title
Beck Anxiety Inventory (BAI)
Description
The BAI is a self-report measure of general anxiety symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise M Sloan, PhD
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Providence VA Medical Center, Providence, RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available through Freedom of Information Act.
Citations:
PubMed Identifier
30499227
Citation
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.
Results Reference
background
PubMed Identifier
26718094
Citation
Sloan 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.
Results Reference
background
PubMed Identifier
34941354
Citation
Marx 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.
Results Reference
derived

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Group Treatment for PTSD: A Randomized Clinical Trial With Veterans

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