Coping Skills Training for Adolescents With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Coping Skills Training; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 weekly sessions of behavioral treatment; 8 weekly sessions of fibromyalgia education
Other intervention name(s): cognitive-behavioral therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Juvenile Fibromyalgia Syndrome; JPFS; Fibromyalgia; Chronic Pain; Pediatric Pain; Juvenile Fibromyalgia