Behavioral Insomnia Therapy for Fibromyalgia
Behavioral insomnia therapy
Fibromyalgia
+ Insomnia
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Treatment Study
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Summary
This study tests the effectiveness of a nondrug treatment for the insomnia that often occurs in people with fibromyalgia. The treatment is a type of psychotherapy called cognitive-behavioral therapy. Cognitive-behavioral therapy combines cognitive therapy, which can modify or eliminate thought patterns contributing to the person's symptoms, and behavioral therapy, which aims to help the person change his or her behavior. Fibromyalgia (FM) is a prevalent and debilitating condition that contributes to impaired occupational and social functioning and increased disability among affected individuals. The vast majority of people with FM experience persistent sleep disturbances (e.g., onset difficulty, repeated or extended awakenings, nonrestorative sleep) that worsen other FM-related symptoms (e.g., chronic pain, fatigue) and sustain their general dysfunction. Pharmacologic treatments (e.g., antidepressants, hypnotics) may reduce symptoms for some people with FM, 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 suggest 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) that has proven effective for reducing sleep disturbances perpetuated by such underlying cognitive/behavioral mechanisms. The major objectives of this project are to conduct 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 and daytime pain, fatigue, and distress symptom complex that defines FM. One arm of this study's three-by-four 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 four time points (i.e., baseline, mid-treatment, post-treatment, and 6-month follow-up periods) at which we will assess outcome. We will assess participants at all four time points with objective (wrist actigraphy) and subjective (sleep logs, Insomnia Symptom Questionnaire) measures of sleep improvements, measures of subjective pain, and questionnaires that assess mood (State-Trait Anxiety and Beck Depression Scales) and general quality of life (SF-36). We will conduct multivariate statistical analyses and tests of clinical significance with these various measures. We will also conduct exploratory analyses to determine if polysomnographically-derived sleep measures obtained prior to treatment correlate with initial levels of pain and 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. Individuals interested in participating in this study should live within reasonable commuting distance from the Duke University Medical Center (Durham, NC), because this research requires multiple outpatient visits for screening and treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.
Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.
Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
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