MBSR for Gulf War Syndrome
The proposed pilot study is a two arm randomized, controlled clinical trial that will evaluate whether a standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Sixty veterans meeting diagnostic criteria for Gulf War Syndrome will be randomized to treatment as usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures will be collected at baseline, immediate post-MBSR, and 6 months post intervention. Measures will be obtained at equivalent time points for veterans randomized to TAU only. Following completion of all study activities, veterans randomized to TAU only will have the opportunity to enroll in MBSR.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of a Mindfulness Based Intervention for Gulf War Syndrome|
- The Short-form McGill Pain Questionnaire; the Multidimensional Fatigue Inventory; The Cognitive Failures Questionnaire [ Time Frame: 8 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
Behavioral: Mindfulness-based stress reduction
The most common clinical method of teaching mindfulness is a standardized class called "mindfulness-based stress reduction" (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon.
No Intervention: Arm 2
Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
A randomized controlled trial with two arms. 60 veterans meeting diagnostic criteria for Gulf War Syndrome will be randomized to standard care or standard care plus an 8-week course of course of Mindfulness-Based Stress Reduction (MBSR). Study measures will be collected at baseline, immediate post-MBSR (within one week of completion of the MBSR class) and 6 months following completion of the MBSR course. Measures will be obtained at equivalent time points for veterans randomized to usual care only. Following completion, veterans randomized to standard care only will have the opportunity to enroll in MBSR.
This pilot study will assess whether there is sufficient evidence of benefit to warrant further study, and will gather data that will allow estimation of the sample size needed in future studies. We will also obtain measures working memory and attention, in addition to patient self-report measures of symptoms, in order to provide additional assessment of whether MBSR is effective. This project is prerequisite to a larger study.
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||David J. Kearney, MD||VA Puget Sound Health Care System Seattle Division, Seattle, WA|