Rationale: When Gulf War veterans suffer from multiple chronic health conditions such as sleep dysfunction, unexplained fatigue, and chronic pain, their lives can be shattered. Yet, decades after the conflict, Gulf War Illness (GWI) remains a medical enigma that challenges researchers and resists effective treatment. Health care providers still can offer relatively little to help veterans with GWI. However, this chronic multisymptom illness has attracted research and political attention, as many recognize the urgent need to develop effective treatments for physical and psychological ailments related to military service. We believe the intervention we have been studying, called Mind-Body Bridging (MBB), offers an effective way to treat GWI.

Objectives: We propose to conduct an exploratory randomized clinical trial to evaluate how a sleep-focused mind-body program may enhance primary care for GWI patients at the Veteran's Affairs Salt Lake City Health Care System. The trial will focus on Gulf War veterans who are suffering from sleep disturbance and associated co-morbid conditions that have not been relieved by standard medical care.

Our research team is experienced in clinical research and practice, particularly in the areas of pain, sleep, irritable bowel syndrome, complex multisystem illness, mind-body medicine, and primary care. We also have been collaborating with Department of Veterans Affairs (VA) clinicians who use MBB in clinical practice. In a previous study with veterans, we have found that a brief sleep-focused MBB program significantly improved not only sleep but also PTSD symptoms, even though the MBB program did not specifically address PTSD. This result is consistent with increasing evidence that sleep problems (co-morbid insomnia) exacerbate many health conditions.

The broad objective of this trial is to evaluate and compare the clinical benefit of two sleep-focused therapeutic interventions: MBB and Supportive Education (SED). We will recruit 72 Gulf War veterans, who first will undergo a comprehensive evaluation performed by our medical and psychological staff 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 patient will be evaluated again after treatment has ended. Three months after treatment ends, patients will complete follow-up questionnaires. These assessments will help us to evaluate both the efficacy of the therapy programs and any differences in individual treatment response.

Ultimate Applicability and Potential Impacts: The scientific and clinical implications of this project are potentially far-reaching. First, if successful, our project can provide military medicine with a fairly simple, brief, safe, and cost-effective clinical primary care intervention to relieve GWI suffering. A second longer-term goal of our research program is to contribute to the development of personalized medicine, helping to define the best clinical care for patients with diverse military and personal life experiences. The studied treatment may also be useful in field military operations, minimizing or even preventing physical and mental suffering of military personnel. We hope that positive findings in the proposed exploratory clinical trial may encourage larger-scale clinical trials, in which our general research approach and our advanced data analytic technique can help elucidate the underlying mechanisms of sleep disturbance and other co-morbid GWI symptoms. Through such efforts, we will have a best opportunity to understand not only whether the therapy programs work, but also how they work and for whom these treatments can be most helpful. We strongly believe this line of research has great potential to quickly provide the VA Health Care System with ways to care more effectively for GWI patients.