Coping Skills Training for Adolescents With Fibromyalgia
NCT ID: NCT00086047
Last Updated: 2017-09-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
114 participants
INTERVENTIONAL
2004-07-31
2010-07-31
Brief Summary
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Study hypotheses: 1) Adolescents who receive coping skills training combined with their usual medical care will show significantly greater reductions in functional disability, pain, and depressive symptoms at the end of the acute treatment phase than adolescents who receive fibromyalgia education with their usual medical care. 2) Adolescents who receive coping skills training with their usual medical care will show significantly lower levels of functional disability, pain, and depressive symptoms at the end of a six-month maintenance phase than adolescents who receive fibromyalgia education with their usual medical care.
Detailed Description
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This study will last 34 weeks. Participants will be recruited from three pediatric rheumatology clinics. Patients will be randomly assigned to one of two groups: CST plus usual medical care or education plus usual medical care. There will be 6 medical visits, spaced 4 to 5 weeks apart. In addition, patients will attend 8 individual sessions of CST or education over the first 8 weeks of the study. CST sessions will include training in cognitive-behavioral techniques of pain management for the adolescent and behavioral management techniques for their parents. Education sessions will include education on fibromyalgia and discussion about lifestyle issues, but no training in pain management procedures.
Patients will be evaluated at Week 9 and will be followed for an additional 6-month maintenance phase. During this maintenance phase, adolescents will continue to receive their usual medical care and will attend 2 additional sessions of CST or education. There will be one final evaluation at the end of the maintenance phase.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Coping Skills
Patients will receive 8 weeks of behavioral training in pain coping strategies
Coping Skills Training
8 weekly sessions of behavioral treatment
Education
Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
Education
8 weekly sessions of fibromyalgia education
Interventions
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Coping Skills Training
8 weekly sessions of behavioral treatment
Education
8 weekly sessions of fibromyalgia education
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Average pain intensity greater than 4 on the Visual Analog Scale
* Functional disability score greater than 7
* Stable medications for 8 weeks prior to study entry
Exclusion Criteria
* Significant developmental delay or impairments, such as autism, cerebral palsy, or mental retardation
* Present or lifetime psychiatric diagnosis that meets DSM-IV criteria for panic disorder, bipolar disorder, major depressive disorder, or psychosis
* Opioid medications are disallowed when used on an ongoing basis for treatment of fibromyalgia pain
11 Years
18 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Susmita Kashikar-Zuck, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Kosair Charities Pediatric Center
Louisville, Kentucky, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation, Division of Pediatrics
Cleveland, Ohio, United States
Countries
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References
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