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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR049840 | U.S. NIH Grant/Contract | View source | |
| NIAMS-095 |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will partake in cognitive behavioral therapy for 12 weeks. |
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| 2 | Experimental | Participants will partake in tai chi chih for 12 weeks. |
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| 3 | Active Comparator | Participants will act as a control and attend educational sessions for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity | Measured at Week 12 and Months 4 and 8 follow-up | |
| Health functioning | Measured at Week 12 and Months 4 and 8 follow-up | |
| Inflammation, measured by levels of IL-1, IL-6, and tumor necrosis factor (TNF)-alpha | Measured at Week 12 and Months 4 and 8 follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Mood disturbances | Measured at Week 12 and Months 4 and 8 follow-up | |
| Coping | Measured at Week 12 and Months 4 and 8 follow-up | |
| Helplessness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perry M. Nicassio, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cousins Center for Psychoneuroimmunology, UCLA | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39304956 | Derived | Azizoddin DR, Olmstead R, Anderson KA, Hirz AE, Irwin MR, Gholizadeh S, Weisman M, Ishimori M, Wallace D, Nicassio P. Socioeconomic status, reserve capacity, and depressive symptoms predict pain in Rheumatoid Arthritis: an examination of the reserve capacity model. BMC Rheumatol. 2024 Sep 20;8(1):46. doi: 10.1186/s41927-024-00416-4. | |
| 37066198 | Derived | Azizoddin D, Olmstead R, Anderson KA, Hirz AE, Irwin MR, Gholizadeh S, Weisman M, Ishimori M, Wallace D, Nicassio P. Socioeconomic Status, Reserve Capacity, and Depressive Symptoms Predict Pain in Rheumatoid Arthritis: An Examination of the Reserve Capacity Model. Res Sq [Preprint]. 2023 Apr 7:rs.3.rs-2758092. doi: 10.21203/rs.3.rs-2758092/v1. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D010146 | Pain |
| D002908 | Chronic Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Tai Chi Chih | Behavioral | 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. |
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| Health Education Seminar | Behavioral | 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. |
|
| Measured at Week 12 and Months 4 and 8 follow-up |
| 26212464 | Derived | Ormseth SR, Draper TL, Irwin MR, Weisman MH, Arechiga AE, Hartoonian N, Bui T, Nicassio PM. Multidimensional Model of Disability and Role Functioning in Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1686-92. doi: 10.1002/acr.22658. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |