Group CBT for PTSD (GCBT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01544088
First received: February 28, 2012
Last updated: May 5, 2014
Last verified: May 2014

February 28, 2012
May 5, 2014
July 2012
June 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01544088 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Group CBT for PTSD
Group CBT for Chronic PTSD: RCT With Veterans

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
PTSD
  • 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.
  • 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.
  • Experimental: Arm 1
    Group Cognitive Behavioral treatment (GCBT)
    Intervention: Behavioral: Group Cognitive Behavioral Treatment (GCBT)
  • Active Comparator: Arm 2
    Present Centered Group Treatment
    Intervention: Behavioral: Present Centered Group Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
196
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Denise M Sloan, PhD (857) 364-6333 Denise.Sloan@va.gov
United States
 
NCT01544088
MHBA-015-11F, 1 I01 CX000467-01A1
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Denise M. Sloan, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Department of Veterans Affairs
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP