Coping Skills Training for Adolescents With Fibromyalgia
|ClinicalTrials.gov Identifier: NCT00086047|
Recruitment Status : Completed
First Posted : June 23, 2004
Results First Posted : November 6, 2013
Last Update Posted : September 20, 2017
Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and difficulty in an adolescent's day-to-day activities. The purpose of this study is to determine whether coping skills training, when combined with usual medical care, can reduce pain and disability in adolescents with fibromyalgia.
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Coping Skills Training Behavioral: Education||Phase 3|
Juvenile Primary Fibromyalgia Syndrome (JPFS) is a debilitating chronic pain condition that occurs in adolescence and is characterized by persistent pain, multiple tender points, sleep difficulty, and fatigue. The cause of JPFS is unknown and there is no known cure. Children and adolescents with JPFS have difficulty with daily functioning, miss a great deal of school, and experience increased emotional distress compared to their peers. Fibromyalgia syndrome appears to be resistant to treatment in adulthood, so early behavioral treatment for JPFS with long-term beneficial effects would be useful. This study will evaluate the efficacy of coping skills training (CST) when combined with usual medical care in reducing functional disability, pain intensity, and depressive symptoms in adolescents with JPFS. This study will also determine whether improvements can be sustained long-term.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial in Juvenile Fibromyalgia|
|Study Start Date :||July 2004|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
Experimental: Coping Skills
Patients will receive 8 weeks of behavioral training in pain coping strategies
Behavioral: Coping Skills Training
8 weekly sessions of behavioral treatment
Other Name: cognitive-behavioral therapy
Active Comparator: Education
Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
8 weekly sessions of fibromyalgia education
- Change in FDI (Functional Disability Inventory) Scores at End of Study [ Time Frame: Baseline and 6 months (end of study) ]Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60)
- Pain Intensity [ Time Frame: 9 weeks and 6 months ]
- Depressive Symptoms [ Time Frame: 9 weeks and 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086047
|United States, Kentucky|
|Kosair Charities Pediatric Center|
|Louisville, Kentucky, United States, 40202|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Cleveland Clinic Foundation, Division of Pediatrics|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Susmita Kashikar-Zuck, PhD||Children's Hospital Medical Center, Cincinnati|