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Pain and Stress Management for People With Rheumatoid Arthritis

Disclosure and Skills Training for Rheumatoid Arthritis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00088764
Enrollment
280
Registered
2004-08-05
Start date
2005-02-28
Completion date
2009-06-30
Last updated
2013-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Stress, Coping, Expressive Writing, Self-Efficacy, Disclosure

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.

Interventions

8 sessions of pain and stress coping skills training

4 sessions of writing about stress

8 sessions of learning about rheumatoid arthritis

BEHAVIORALHealth behavior writing

4 sessions of writing about various health behaviors

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Joint countone year

Secondary

MeasureTime frame
Psychological impairmentone year
Painone year
Physical disabilityone year
C-reactive proteinone year
Fatigueone year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026