Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072657
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2003-11-07
Brief Title:
Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Behavioral Treatments for Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2013-04
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:
Rheumatoid arthritis RA is a chronic illness Patients with RA often experience significant pain and depression This study will evaluate two programs designed to improve the symptoms of RA cognitive-behavioral therapy CBT and Tai Chi Chih TCC compared to a health education seminar
Detailed Description:
Rheumatoid arthritis is a progressive inflammatory illness marked by severe functional declines significant economic and social costs and significant psychological distress Environmental and psychosocial factors such as stress mood disturbance and coping mechanisms may contribute to changes in important health outcomes including disability and disease activity in RA This study will compare CBT with TCC a relaxation-based intervention combining elements of slow gentle movement with meditation against a more traditional health education seminar Outcome measures will include psychological adaptation mood disturbance sleep quality physiological adaptation and disease severity
Two hundred-ten patients will be randomly assigned to either CBT TCC or a control group The CBT intervention will have three phases 1 education on the nature of the adjustment process in chronic illness 2 coping skill development and 3 generalization and application of skills to everyday situations Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each Participants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher TCC participants will have 50 to 60 minute biweekly sessions during the 12-week study Control group participants will attend weekly group educational sessions these sessions will provide general knowledge about arthritis health and illness and will include lectures demonstrations and question-and-answer sessions with experts in rheumatology sleep science and behavioral medicine
Participants will be assessed prior to beginning treatment at mid-treatment Week 6 and again at the end of treatment Week 12 to 13 The long term effect of interventions will be assessed at follow-up interviews 4 months and 8 months after the end of formal treatment Psychosocial adaptation mood disturbance and sleep quality self-reported pain and immune function will be measured at all five assessment periods
Two hundred-ten patients will be randomly assigned to either CBT TCC or a control group The CBT intervention will have three phases 1 education on the nature of the adjustment process in chronic illness 2 coping skill development and 3 generalization and application of skills to everyday situations Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each Participants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher TCC participants will have 50 to 60 minute biweekly sessions during the 12-week study Control group participants will attend weekly group educational sessions these sessions will provide general knowledge about arthritis health and illness and will include lectures demonstrations and question-and-answer sessions with experts in rheumatology sleep science and behavioral medicine
Participants will be assessed prior to beginning treatment at mid-treatment Week 6 and again at the end of treatment Week 12 to 13 The long term effect of interventions will be assessed at follow-up interviews 4 months and 8 months after the end of formal treatment Psychosocial adaptation mood disturbance and sleep quality self-reported pain and immune function will be measured at all five assessment periods
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 |
|---|---|---|---|
| R01AR049840 | NIH | None | None |
| NIAMS-095 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR049840 |