Pain and Stress Management for People with 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.

Official Title

Disclosure and Skills Training for Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

Study Type

Interventional

Study Design

Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcomes: Joint count; pain; physical disability; psychological impairment; C-reactive proteinSecondary Outcomes: RA flares; medication use; fatigue; morning stiffnessTwo 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. Last follow-up: December 2008; Data entry closure: January 2009

Study Start

Study start: February 2005; Expected completion: May 2009

Eligibility & Criteria

Inclusion Criteria:- Meet American College of Rheumatology (ACR) 1987 criteria for RA Exclusion Criteria:- Other disorders that would significantly affect function (e.g., lupus, chronic obstructive pulmonary disease [COPD], congestive heart failure [CHF], cancer) – Judged by the physician to have cognitive impairment (dementia, retardation, psychosis) or illiteracy – Has experienced recent (last 6 months) significant stressor resulting in substantial emotional instability – Currently in psychotherapy or a formal behavioral pain management program – Unable to walk. Participants who use walking aids are not excluded. – Physically unable to write

Total Enrolment

280

Contact Details

Wayne State University, Detroit, Michigan, 48202, United States Mark A. Lumley, PhD 313-577-2838 mlumley@wayne.edu Mark A. Lumley, PhD, Principal Investigator