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.

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Behavior: Coping skills training  Behavior: Written emotional disclosure  Behavior: Arthritis education  Behavior: Health behavior writing	Phase II

Further Study Details: 

Primary Outcomes: Joint count; pain; physical disability; psychological impairment; C-reactive protein
Secondary Outcomes: RA flares; medication use; fatigue; morning stiffness
Expected Total Enrollment:  280

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.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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

Michigan
      Wayne State University, Detroit,  Michigan,  48202,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27708,  United States; Not yet recruiting

Study chairs or principal investigators

Mark A. Lumley, PhD,  Principal Investigator,  Wayne State University   

Study ID Numbers:  NIAMS-122; 1R01 AR49059-01A1
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00088764
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08