Rheumatoid Arthritis Clinical Trial
Official title:
Disclosure and Skills Training for Rheumatoid Arthritis
Self-management of rheumatoid arthritis (RA) symptoms using written emotional disclosure (ED), coping skills training (CST), or a combination of both may benefit people with RA. The purpose of this study is to determine the benefits of ED, CST, or CST and ED together in adults with RA. This study will be conducted at Wayne State University in Detroit, Michigan and Duke University Medical Center in Durham, North Carolina.
Two self-management strategies hold promise for improving the health of people with RA: ED
(writing about stress, RA, and coping options) and CST (learning six pain and stress coping
skills). A strategy integrating ED with CST may be more effective than either intervention
alone. This study will compare the effectiveness of ED, CST, ED in combination with CST, and
control groups in alleviating the symptoms of RA.
This study will last until May 2009. Participants with RA will be randomly assigned to 1 of
4 treatment groups. Each participant will receive 3 writing sessions and 8 training
sessions. Group 1 will receive ED writing followed by CST; Group 2 will receive ED writing
followed by arthritis education; Group 3 will receive health behavior writing followed by
CST; and Group 4 will receive health behavior writing followed by arthritis education.
Participants will be evaluated at baseline and at Months 1, 4, and 12 for pain, physical
disability, psychological impairment, and disease activity. In addition, participants will
record daily diaries for 30 days regarding their pain, symptoms, coping, stress, and mood
prior to each of the evaluations. Changes in health status over time will be compared among
groups.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
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