Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086047
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2004-06-22
Brief Title:
Coping Skills Training for Adolescents With Fibromyalgia
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Randomized Clinical Trial in Juvenile Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and difficulty in an adolescents 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR050028 | NIH | None | httpsreporternihgovquickSearchR01AR050028 |