Fibromyalgia Clinical Trial
Official title:
Behavioral Insomnia Therapy With Fibromyalgia
Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points. The majority of individuals with FM report sleep problems, including delayed sleep onset, extended awakenings, and non-restorative sleep. These sleep disturbances may worsen FM-related pain, fatigue, low mood, and low energy. The purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances and improving other FM-related symptoms.
Status | Completed |
Enrollment | 111 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Reside in or around Durham, NC - History of insomnia complaints for more than 1 month - Diagnosis of primary FM - Diagnosis of insomnia Exclusion Criteria: - Terminal illness or acute serious medical illness - Secondary FM or condition other than FM that seriously compromises sleep - Current psychiatric illness or currently suicidal - Substance abuse or dependence - Other primary sleep disorder (e.g., sleep apnea or restless legs syndrome) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total wake time | Measured immediately and 6 months post-treatment | No | |
Primary | Total sleep time | Measured immediately and 6 months post-treatment | No | |
Primary | Sleep efficiency | Measured immediately and 6 months post-treatment | No | |
Secondary | Sleep onset latency | Measured immediately and 6 months post-treatment | No | |
Secondary | Wake time after sleep onset | Measured immediately and 6 months post-treatment | No | |
Secondary | Score on an insomnia rating scale | Measured immediately and 6 months post-treatment | No | |
Secondary | Score on a fatigue rating scale | Measured immediately and 6 months post-treatment | No | |
Secondary | Score on a mood rating scale | Measured immediately and 6 months post-treatment | No | |
Secondary | Subjective pain ratings | Measured immediately and 6 months post-treatment | No | |
Secondary | Score on a health-related quality of life scale | Measured immediately and 6 months post-treatment | No |
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