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Pain and Stress Management for People With Rheumatoid Arthritis

Wayne State University logo

Wayne State University

Status and phase

Completed
Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Behavioral: Health behavior writing
Behavioral: Arthritis education
Behavioral: Written emotional disclosure
Behavioral: Coping skills training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00088764
NIAMS-122
1R01AR049059 (U.S. NIH Grant/Contract)
R01AR049059 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

280 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

280 participants in 2 patient groups

1
Experimental group
Description:
Education: Either coping skills training or arthritis education interventions
Treatment:
Behavioral: Arthritis education
Behavioral: Coping skills training
2
Experimental group
Description:
Writing: Either emotional disclosure writing or health behavior writing
Treatment:
Behavioral: Written emotional disclosure
Behavioral: Health behavior writing

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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