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NCT00086047 · ClinicalTrials.gov registry record · Phase 3
Coping Skills Training for Adolescents With Fibromyalgia
A Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 114
- Enrollment target
NCT00086047: Completed Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT00086047 is a Phase 3 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 114 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00086047, a Phase 3 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 114 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- BEHAVIORAL Education
- BEHAVIORAL Coping Skills Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2004-07 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00086047 record still lists
NCT00086047 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Education is the first listed.
NCT00086047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00086047 about?
NCT00086047 is a clinical study titled "Coping Skills Training for Adolescents With Fibromyalgia". 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 adolesce...
What is the current status of trial NCT00086047?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2004-07. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00086047?
The interventions under investigation include: Education (BEHAVIORAL), Coping Skills Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT00086047?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00086047's enrollment target sits among peer trials
114 1648th of 2000 higher than 350 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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