Behavioral Insomnia Therapy With Fibromyalgia

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DESCRIPTION (provided by applicant): Fibromyalgia (FM) is a prevalent and debilitating condition characterized by chronic widespread pain, persistent daytime fatigue, sleep disturbances, low mood, loss of stamina, and resultant disability. To date, research has documented the benefits of pharmacotherapy (antidepressants) to manage FM-related pain and mood disturbances and various nonpharmacologic interventions to reduce stress, bolster illness-coping abilities, and increase fitness/stamina. Whereas, most FM patients report chronic sleep disturbances (e.g., delayed sleep onset, fragmented or un-refreshing sleep), the benefits of sleep-focused interventions for FM symptom management have received relatively little research attention. Nevertheless, our recently completed R21 project showed that a cognitive-behavioral insomnia therapy (CBT) is a promising intervention for reducing sleep difficulties and other key symptoms in FM sufferers. Post-hoc analyses suggested that the addition of sleep hygiene (SH) education to CBT strategies might enhance treatment efficacy. Furthermore, pilot regression analyses suggested the usefulness of sleep disturbance measures of as mediators and moderators of FM pain improvement. The project proposed is designed to confirm and extend these findings in a moderately large FM sample. A total of 111 FM patients will be randomized either to a CBT/SH + usual care (DC) condition (n = 37), a Placebo Control (PC) therapy + UC (n = 37) or UC alone (n = 37). Polysomnography conducted before and after eight weeks of treatment and sleep log monitoring and actigraphy conducted before treatment, after treatment, and at a 6-month follow-up will be used to assess sleep improvements. Self-report measures of pain, mood, daytime fatigue, and quality of life will be obtained before, during (mid-treatment), and after treatment and at follow-up to assess changes in other key FM symptoms. Both standard statistical analyses and tests of clinical significance will be used to evaluate the CBT/SH intervention. Additionally, measures extracted from sleep logs, standard scorings of the polysomnograms, and sleep EEG spectral analyses will be considered in regression analyses to identify sleep-based mediators and moderators of improvements in key non-sleep FM symptoms (e.g., pain, fatigue). Results of this trial should provide insights into the pathophysiology and management of FM.