Group Based Exposure Therapy for Combat-Related PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00535223
First received: September 24, 2007
Last updated: November 9, 2012
Last verified: November 2012

September 24, 2007
November 9, 2012
July 2007
July 2010   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00535223 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Group Based Exposure Therapy for Combat-Related PTSD
Group Based Exposure Therapy for Combat PTSD: RCT and Feasibility Study

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
  • 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.
Experimental: Arm 1
See below
Interventions:
  • Behavioral: Group Based Exposure Therapy
  • Behavioral: Present Centered Group Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
August 2012
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male veterans diagnosed with war-related PTSD as assessed by the CAPS. Patients must provide a DD214 or other documentation of war exposure.
  2. Patients must have the ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments (as evident by the ability to pass informed consent test, to fill out self-report assessment measures and to respond appropriately during the clinical interview).
  3. Patients must be either stable on psychotropic medication (defined as no additional psychotropic medications or significant increases in previously prescribed psychotropic medications for a period of at least three months) or not on psychotropic medication.
  4. Patients must be currently in treatment within the Mental Health Clinic (MHC) of the Atlanta VA Medical Center for a minimum of four months prior to participation. This would insure adequate psychiatric coverage and case management. If a change in medication were needed during the study, it would be made. Such changes would be tracked for analysis if they occur in a significant number of patients.
  5. Patients must have the support of their current Mental Health Clinic Treatment Team to participate in the study.

Exclusion Criteria:

Exclusion criteria are intended to exclude patients who might be harmed by study participation and to yield as ecologically valid a sample as possible.

  1. Patients with current or history of mania or schizophrenia would be excluded because the stress of exposure therapy may precipitate an increase in symptoms of these co-morbid conditions that could interfere with the patient's ability to benefit from treatment.
  2. Patients suffering from current active psychosis, active mania, or sufficient mental impairment, as assessed by a Mini Mental State Exam score below 24, which would prevent the patient from providing valid consent or participating safely or understanding the treatment.
  3. Patients with current, prominent suicidal ideation. All patients would be screened for suicidal ideation and intention by the RC in the initial screening and again by the IA in the initial assessment through a brief clinical interview. A BDI #9 score above 3 would prompt a more in-depth inquiry concerning suicidal thoughts and intentions during the initial assessment.
  4. Patients who currently meet diagnostic criteria for substance abuse or dependence or have met such criteria during the previous three months (as measured by the clinical interview and the Kreek-McHugh-Schluger-Kellogg scale (50)).
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00535223
MHBA-010-06F
Not Provided
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: David Ready, PhD MS VA Medical Center, Decatur
Department of Veterans Affairs
November 2012

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