|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00072657 |
Purpose
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.
| Condition | Intervention |
|
Rheumatoid Arthritis |
Behavioral: Cognitive Behavioral Therapy Behavioral: Tai Chi Chih Behavioral: Health Education Seminar |
| MedlinePlus related topics: | Coping with Chronic Illness Depression Rheumatoid Arthritis |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Behavioral Treatments for Rheumatoid Arthritis |
| Estimated Enrollment: | 210 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Participants will partake in cognitive behavioral therapy for 12 weeks.
|
Behavioral: Cognitive Behavioral Therapy
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.
|
|
2: Experimental
Participants will partake in tai chi chih for 12 weeks.
|
Behavioral: Tai Chi Chih
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.
|
|
3: Active Comparator
Participants will act as a control and attend educational sessions for 12 weeks.
|
Behavioral: Health Education Seminar
Control group participants will attend weekly group educational sessions; these sessions will provide general knowledge about arthritis health and illness, and they will include lectures, demonstrations, and question-and-answer sessions with experts in rheumatology, sleep science, and behavioral medicine.
|
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| Cousins Center for Psychoneuroimmunology, UCLA | Recruiting | ||||
| Los Angeles, California, United States, 90095 | |||||
| Contact: Perry M. Nicassio, PhD 310-825-3141 | |||||
| Contact: Jennifer Pike, PhD 310-825-2109 jpike@ucla.edu | |||||
| Principal Investigator: | Perry M. Nicassio, PhD | University of California, Los Angeles |
More Information
| Responsible Party: | UCLA ( Perry M. Nicassio, PhD ) |
| Study ID Numbers: | R01 AR49840, NIAMS-095 |
| First Received: | November 7, 2003 |
| Last Updated: | September 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00072657 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|