Combined Behavioral & Analgesic Trial for Fibromyalgia (COMBAT-FM)

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DESCRIPTION (provided by applicant): Fibromyalgia (FM) is a chronic widespread pain syndrome with a number of concurrent symptoms (e.g., sleep difficulties, fatigue, depression, anxiety), unknown pathogenesis, and no well-replicated biological markers that is estimated to affect 3-6 million people in the United States. The diversity of symptoms reported by FM patients is consistent with the view that FM is a multisystem disorder, involving a complex interaction of biological, psychological, and social mechanisms. Although evaluations of a number pharmacological have shown beneficial effects none are curative. These treatments reduce pain by approximately 35% but no more than half of patients experience clinically meaningful improvements. Similar outcomes have been reported by nonpharmacological treatments, particularly cognitive-behavior therapy (CBT), which has been shown to produce equivalent benefits to medication in reducing pain and improving function. The modest outcomes of these montherapies have led to calls for combination trials of drugs and nondrug treatments. No studies have evaluated the incremental benefits of combining CBT and medication as suggested in the American Pain Society. A primary objective of the proposed research is to evaluate the combination of a modified version of CBT, CBTfm that targets fatigue, sleep, pain, depression, and anxiety and tramadol, a medication that has analgesic, antiserotonergic properties, and inhibits the neuronal reuptake of norepinephrine for FM. Based on published literature and evidence-based clinical practice guideline, we hypothesize that the combination of CBTfm+Tramadol will lead to significantly greater improvement than Health Education + Tramadol, Health Education + Placebo, or CBTfm +Placebo. A second objective is to use actigraphy, an objective measure of sleep and activity, to evaluate the "perceptual dissociation" between patients' perceptions of their sleep quality and activity and objective indices of these two key variables. Based on evidence that FM patients avoid activity not only because of current exhaustion but also because of believe that fatigue and pain will worsen if they are active, we hypothesize that there will be a weak relationship between patients' perceptions and the objective indices of sleep and activity. The mechanisms by which treatments for FM are effective for FM are unknown. A 3rd objective is to evaluate psychological and neurophysiological variables as potential mediators of outcome. Finally, the 4th objective is to test a model of the mediational effects of fatigue on activity level, arising from pain, sleep and mood disturbance in FM. The results will have important implications for developing optimal treatment programs for FM, the mechanisms understanding treatment outcome, and the associations among sleep, fatigue, activity, pain, and mood in this prevalent pain condition. PUBLIC HEALTH RELEVANCE: The proposed research addresses treatment of fibromyalgia (FM), a prevalent syndrome that is estimated to affect 3 to 5 mission Americans. FM is characterized by widespread pain, fatigue, sleep disturbance, cognitive symptoms, depression, anxiety, among other symptoms. FM can lead to significant disability, complex management decision, and economic burden on society given this population's extensive use of health services. There is currently no cure for FM and available treatments only reduce symptoms by approximately 35% and in a minority of patients. This has led to calls for treatments that combine both pharmacological and nonpharmacological modalities. This project will evaluate the effects of a combination treatment based on promising individual treatments, namely, cognitive-behavior therapy and tramadol. Both of these treatments have been recommend as components of a comprehensive treatment approach to FM by evidence-based clinical practice guidelines. The combination has the potential to maximize the benefits of each individual treatment and to reduce suffering and improve the health-related quality of life for those with FM.