Group Based Exposure Therapy for Combat-Related PTSD
The purpose of this randomized controlled trial is to determine if Group Based Exposure Therapy (GBET) is more effective than treatment as usual in reducing the symptoms of war-related Posttraumatic Stress Disorder (PTSD).
Posttraumatic Stress Disorder
Behavioral: Group Based Exposure Therapy
Behavioral: Present Centered Group Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Group Based Exposure Therapy for Combat PTSD: RCT and Feasibility Study|
- Blind independent assessment using clinician administered and self-report measures of Posttraumatic Stress Disorder administered prior to treatment, immediately post-treatment, six months post-treatment and one year post-treatment [ Time Frame: one year post-treatment ] [ Designated as safety issue: No ]No significant difference were found between study conditions at one year post treatment. The primary hypothesis were not supported. Both forms of group therapy appeared to lead to improvement in PTSD and depression
- Blind independent assessment using self-report measures of depression and relationship conflict tactics administered prior to treatment, immediately post-treatment, six-months post-treatment and one year post-treatment. [ Time Frame: one year post-treatment ] [ Designated as safety issue: No ]At one year follow-up assessment, GBET participants reported significantly greater improvement than PCGT participants on several secondary, self-report outcome measures including measures of spiritual and personal meaning, as well as PTSD-related cognitions
|Study Start Date:||July 2007|
|Study Completion Date:||August 2012|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Behavioral: Group Based Exposure Therapy
GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.Behavioral: Present Centered Group Therapy
Present Centered Group Therapy includes psych-education about PTSD and a problem solving "here and now" focus.
Over 250,000 veterans with war-related PTSD were treated in the VA system in the VA system last year. Although the VA set up over 140 specialized PTSD programs and 206 Vet Centers to treat these veterans, a survey of practice patterns suggests that most VA PTSD treatment is not consistent with published treatment guidelines. This is mainly due to the very rare use of exposure therapy which is surprising considering that there is more empirical support for exposure therapy than for any other PTSD treatment. The failure to utilize evidence-based treatment may explain why studies have generally failed to support the efficacy of VA PTSD treatment. Group Based Exposure Therapy (GBET) is consistent with PTSD treatment guidelines and includes a large amount of exposure therapy. An open trial of 102 war veterans suggests that GBET produces clinically significant and lasting PTSD symptom reductions, as measured by the Clinician Administered PTSD Scale (CAPS), with a large effect size of 1.20 (generalized d). Clinically significant symptoms reductions, defined as a reduction in total CAPS score of 10 or more points, were found in 81 percent of patients. These symptom reductions were maintained on 6-month post-treatment assessments for most patients. Self-report measures of depression, anger, suicidal ideation and PTSD were also significantly reduced when pre-treatment measures were compared to post-treatment scores. This magnitude of symptom change has rarely been reported with VA war-related PTSD patients and there was a low dropout rate (>3%). Caution should be used in interpreting these unusual findings due to the treating clinicians conducting study assessments. Unconscious bias or a desire by patients to please their therapists may have affected outcomes. GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking. Although these findings are encouraging critical questions remain about the generalizability of GBET. The three primary questions are: 1) would similar outcomes be found with the more rigorous test of a randomized controlled trial, 2) can new psychotherapists produce similar outcomes, and 3) can similar outcomes be found at other sites. The proposed study would take the next step by conducting the first controlled trial in which 88 veterans with war-related PTSD will be randomly assigned to either GBET or Treatment as Usual control condition (44 per condition). GBET treatment would be provided by four psychotherapists without prior GBET experience. Independent Assessors blind to treatment condition would assess patients prior to treatment, at post-treatment, 6-months post-treatment and one year post-treatment using CAPS and other standardized measures. If GBET is supported, multi-site study will be proposed to investigate the third primary question.
Potential Impact on Veteran Health Care: GBET was developed within a specialized PTSD program, by VA clinicians working with war veterans and has been a primary mode of treatment within this program for over three years. Most VA PTSD programs have staffing similar to the one the developed GBET and many have more staff. GBET is manualized and could be adopted easily by other VA PTSD programs and Vet Centers. The proposed study would serve as a feasibility study for a multi-site study. If a multi-site study found that GBET produced superior treatment outcomes to those currently in use, it could have a direct impact on the lives of a large number of veterans by leading to better PTSD treatment within the VA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535223
|United States, Georgia|
|VA Medical Center, Decatur|
|Decatur, Georgia, United States, 30033|
|Principal Investigator:||David Ready, PhD MS||VA Medical Center, Decatur|