A Phase 2 interventional study of Coping skills training and Written emotional disclosure in Rheumatoid Arthritis, sponsored by Wayne State University. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-08-15.
Sponsored by Wayne State University · Phase 2 and Interventional
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 280 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Wayne State University is the lead sponsor of 226 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Education: Either coping skills training or arthritis education interventions
Behavioral: Coping skills training · Behavioral: Arthritis education
Writing: Either emotional disclosure writing or health behavior writing
Behavioral: Written emotional disclosure · Behavioral: Health behavior writing
8 sessions of pain and stress coping skills training
4 sessions of writing about stress
8 sessions of learning about rheumatoid arthritis
4 sessions of writing about various health behaviors
Joint count
Time frame: one year
Psychological impairment
Time frame: one year
Pain
Time frame: one year
Physical disability
Time frame: one year
C-reactive protein
Time frame: one year
Fatigue
Time frame: one year
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Wayne State University