Clinical trial NCT00088764: Pain and Stress Management for People With Rheumatoid Arthritis
Official title: Disclosure and Skills Training for Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Stress
Coping
Expressive Writing
Self-Efficacy
Disclosure
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2004-08-05
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

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

Primary outcomes:
measure: Joint count
timeFrame: one year
Secondary outcomes:
measure: Psychological impairment
timeFrame: one year
measure: Pain
timeFrame: one year
measure: Physical disability
timeFrame: one year
measure: C-reactive protein
timeFrame: one year
measure: Fatigue
timeFrame: one year
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Wayne State University
name: Mark A. Lumley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelley JE, Lumley MA, Leisen JC. Health effects of emotional disclosure in rheumatoid arthritis patients. Health Psychol. 1997 Jul;16(4):331-40. doi: 10.1037//0278-6133.16.4.331.
citation: Somers TJ, Shelby RA, Keefe FJ, Godiwala N, Lumley MA, Mosley-Williams A, Rice JR, Caldwell D. Disease severity and domain-specific arthritis self-efficacy: relationships to pain and functioning in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2010 Jun;62(6):848-56. doi: 10.1002/acr.20127.