Group CBT for PTSD (GCBT)
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Purpose
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 consists 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 |
|---|---|---|
|
PTSD |
Behavioral: Group Cognitive Behavioral Treatment (GCBT) Behavioral: Present Centered Group Treatment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Group CBT for Chronic PTSD: RCT With Veterans |
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Beck Depression Inventory, II (BDI-II) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The BDI is a self-report inventory that indexes depression symptom severity.
- Short-Form Health Survey (SF-36) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The SF-36 is a measure of functional impairment.
- Short Index of Problems (SIP) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The SIP is a self-report measure of alcohol use and alcohol-related problems.
- Beck Anxiety Inventory (BAI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The BAI is a self-report measure of general anxiety symptom severity.
| Estimated Enrollment: | 196 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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| Contact: Denise M Sloan, PhD | (857) 364-6333 | Denise.Sloan@va.gov |
| United States, Massachusetts | |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: Denise M Sloan, PhD 857-364-6333 Denise.Sloan@va.gov | |
| Principal Investigator: Denise M. Sloan, PhD | |
| United States, Rhode Island | |
| Providence VA Medical Center, Providence, RI | Recruiting |
| Providence, Rhode Island, United States, 02908 | |
| Contact: William Unger, PhD 401-273-7100 ext 2736 William.Unger@va.gov | |
| Principal Investigator: | Denise M. Sloan, PhD | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01544088 History of Changes |
| Other Study ID Numbers: | MHBA-015-11F, 1 I01 CX000467-01A1 |
| Study First Received: | February 28, 2012 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
randomized controlled trial PTSD cognitive behavioral treatment group treatment |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013