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
  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 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 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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544088

Contacts
Contact: Denise M Sloan, PhD (857) 364-6333 Denise.Sloan@va.gov

Locations
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   
Sponsors and Collaborators
Investigators
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: May 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
randomized controlled trial
PTSD
cognitive behavioral treatment
group treatment

ClinicalTrials.gov processed this record on September 18, 2014