Overview

This trial is active, not recruiting.

Condition ptsd
Treatments group cognitive behavioral treatment (gcbt), present centered group treatment
Phase phase 2
Sponsor VA Office of Research and Development
Start date July 2012
End date September 2017
Trial size 196 participants
Trial identifier NCT01544088, 1I01CX000467-01A1, MHBA-015-11F

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Group Cognitive Behavioral treatment (GCBT)
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)
Present Centered Group Treatment
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.

Primary Outcomes

Measure
Clinician Administered PTSD Scale (CAPS)
time frame: 12 months

Secondary Outcomes

Measure
Beck Depression Inventory, II (BDI-II)
time frame: 12 months
Short-Form Health Survey (SF-36)
time frame: 12 months
Short Index of Problems (SIP)
time frame: 12 months
Beck Anxiety Inventory (BAI)
time frame: 12 months

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Group CBT for Chronic PTSD: RCT With Veterans
Principal investigator Denise M Sloan, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.