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Group CBT for PTSD (GCBT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01544088
First received: February 28, 2012
Last updated: May 4, 2017
Last verified: May 2017
February 28, 2012
May 4, 2017
July 1, 2012
September 2017   (Final data collection date for primary outcome measure)
Clinician Administered PTSD Scale (CAPS) [ Time Frame: 12 months ]
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 ]
    The BDI is a self-report inventory that indexes depression symptom severity.
  • Short-Form Health Survey (SF-36) [ Time Frame: 12 months ]
    The SF-36 is a measure of functional impairment.
  • Beck Anxiety Inventory (BAI) [ Time Frame: 12 months ]
    The BAI is a self-report measure of general anxiety symptom severity.
  • Beck Depression Inventory, II (BDI-II) [ Time Frame: 12 months ]
    The BDI is a self-report inventory that indexes depression symptom severity.
  • Short-Form Health Survey (SF-36) [ Time Frame: 12 months ]
    The SF-36 is a measure of functional impairment.
  • Short Index of Problems (SIP) [ Time Frame: 12 months ]
    The SIP is a self-report measure of alcohol use and alcohol-related problems.
  • Beck Anxiety Inventory (BAI) [ Time Frame: 12 months ]
    The BAI is a self-report measure of general anxiety symptom severity.
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
Intervention Model: Parallel Assignment
Masking: 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
196
September 2017
September 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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01544088
MHBA-015-11F
1I01CX000467-01A1 ( US NIH Grant/Contract Award Number )
Yes
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
Yes
Data will be made available through Freedom of Information Act.
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Denise M Sloan, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
VA Office of Research and Development
May 2017

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