Investigating Clinical Benefits Of A Novel Sleep Focused Mind Body Program On Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial
Technical Report,01 Jul 2012,30 Jun 2013
University of Utah Salt Lake City United States
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The purpose of this study is to conduct an exploratory randomized controlled trial designed to evaluate clinical benefits of a novel mind-body intervention program for primary care management of Gulf War Veterans with sleep disturbance and unrelieved GWI symptoms. The main objective of the study is to evaluate and compare the clinical benefit of two sleep focused therapeutic interventions Mind-Body Bridging MBB and Supportive Education SED on sleep and co-morbid Gulf War related symptoms. MBB consists of cognitive and attentional experiential techniques for cultivating present-focused, non-judgmental awareness of ones body, emotions, and thoughts. We will recruit 72 Gulf War veterans, who first will undergo a comprehensive screening assessment and then will be assigned to one of the two programs MBB or SED. Each Veteran will receive a total of 6 hours of treatment, in 2-hour sessions once a week over 3 consecutive weeks. Each Veteran will be evaluated again after treatment has ended. Three months after treatment ends, Veterans will complete follow-up questionnaires. These assessments will help us to evaluate both the efficacy of the intervention programs and any differences in individual treatment response. Additionally, the project will explore underlying mechanisms of action involved in treatment benefits resulting from MBB and SED by using a biomarker of stress as a proxy indicator of intermediate mechanisms activated by MBB and SED.