Rheumatoid Arthritis Clinical Trial
Official title:
Behavioral Treatments for Rheumatoid Arthritis
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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