Fibromyalgia (FM) is a prevalent and debilitating condition which contributes to impaired occupational/social functioning and increased disability among affected individuals. The vast majority of FM patients present with persistent sleep disturbances (e.g. onset difficulty; repeated or extended awakenings; nonrestorative sleep) which worsen other FM-related symptoms (e.g. chronic pain, fatigue) and sustain their general dysfunction. Pharmacologic treatments (e.g. antidepressants, hypnotics) may produce symptom reduction for some FM patients but many FM patients display little enduring improvement in their sleep and other FM-related symptoms in response to such agents. Our clinical observations and initial pilot work have suggested that factors common among other insomnia subtypes such as conditioned bedtime arousal, erratic sleep/wake scheduling and spending too much time in bed likely perpetuate the sleep problems of these medication-refractory FM patients. Over the past decade, we have developed, refined, and repeatedly tested a cognitive-behavioral therapy (CBT) which has proven effective for reducing sleep disturbances perpetuated by such underlying cognitive/behavioral mechanisms. Moreover, as suggested by the case study reported herein, this treatment holds promise for addressing medication-refractory FM-related sleep disturbance. The proposed project's Specific Aims/Major Objectives entail conducting a prospective randomized clinical trial to confirm these preliminary findings and to determine the efficacy of CBT insomnia treatment for interrupting the disturbed nocturnal sleep/daytime pain, fatigue and distress symptom complex which defines FM. One arm of this study's 3 x 4 factorial design will compare CBT with both a contact control treatment and standard care. The other arm in the design is a repeated-measures factor consisting of 4 time points (i.e. baseline, mid-treatment, post-treatment, and 6 month follow-up periods) at which outcome is assessed. Subjects will be assessed at all 4 time points with objective (wrist actigraphy) and subjective (sleep logs, Insomnia Symptom Questionnaire) measures of sleep improvements, measures of subjective pain, and questionnaires which assess mood (State-Trait Anxiety and Beck Depression Scales) and general quality of life (SF-36). Multivariate statistics and tests of clinical significance will be conducted with these various measures. Exploratory analyses will also be conducted to determine if polysomnographically-derived sleep measures obtained prior to treatment correlate with initial levels of pain/distress or eventual treatment outcome. Results should provide information about the usefulness of CBT for treating FM-related sleep difficulties. Results should also improve understanding of the FM syndrome in general and provide new information about the potential role of behavioral therapy in the overall management of this disorder.
| Carney, Colleen E; Edinger, Jack D; Manber, Rachel et al. (2007) Beliefs about sleep in disorders characterized by sleep and mood disturbance. J Psychosom Res 62:179-88 |
