Pain and Stress Management for People With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: Coping skills training; Behavioral: Written emotional disclosure; Behavioral: Arthritis education; Behavioral: Health behavior writing

• Registration Number: NCT00088764
• Lead Sponsor: Wayne State University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2004-08-04
• Study First Submitted QC: 2004-08-04
• Study First Posted: 2004-08-05
• Study Start: 2005-02
• Primary Completion: 2009-04
• Study Completion: 2009-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-13
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Coping skills training	Education: Either coping skills training or arthritis education interventions
1	Arthritis education	Education: Either coping skills training or arthritis education interventions
2	Written emotional disclosure	Writing: Either emotional disclosure writing or health behavior writing
2	Health behavior writing	Writing: Either emotional disclosure writing or health behavior writing

Primary Outcome Measures

Name	Time	Method
Joint count	one year

Secondary Outcome Measures

Name	Time	Method
Pain	one year
Physical disability	one year
C-reactive protein	one year
Fatigue	one year
Psychological impairment	one year

Trial Locations

Locations (2)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States