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Trial NCT00000397

Resource URI: http://static.linkedct.org/resource/trials/NCT00000397
PropertyValue
linkedct:brief_title Behavioral Insomnia Therapy for Fibromyalgia
linkedct:condition <http://static.linkedct.org/resource/condition/4899>
linkedct:condition <http://static.linkedct.org/resource/condition/6684>
linkedct:criteria Inclusion Criteria: - Insomnia for more than 1 month - Fibromyalgia diagnosis - Participants must live within easy commuting distance of Duke Medical Center, Durham, North Carolina Exclusion Criteria: - Terminal illness - Major psychiatric disorder - Substance abuse - Dependence on hypnotic drugs - Other sleep disorders (sleep apnea, restless legs, etc.) - Other sleep-disturbing medical disorders (painful arthritis, thyroid condition, etc.)
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 65 Years
linkedct:eligibility_minimum_age 21 Years
linkedct:end_date June 2003
linkedct:enrollment 60 (xsd:int)
linkedct:firstreceived_date November 3, 1999
linkedct:id NCT00000397
rdfs:label Trial NCT00000397
linkedct:lastchanged_date December 28, 2006
linkedct:lead_sponsor_agency National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:location <http://static.linkedct.org/resource/location/167116>
linkedct:nct_id NCT00000397
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Behavioral Insomnia Therapy for Fibromyalgia Patients
linkedct:org_study_id R21 AR46094
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/24462>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000397>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/23382>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/5366>
linkedct:secondary_id NIAMS-039
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date July 1999
linkedct:study_design Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date December 2005