Pain and Stress Management for People With Rheumatoid Arthritis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Behavioral: Coping skills training Behavioral: Written emotional disclosure Behavioral: Arthritis education Behavioral: Health behavior writing |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label |
| Official Title: | Disclosure and Skills Training for Rheumatoid Arthritis |
- Joint count [ Time Frame: one year ] [ Designated as safety issue: No ]
- Psychological impairment [ Time Frame: one year ] [ Designated as safety issue: No ]
- Pain [ Time Frame: one year ] [ Designated as safety issue: No ]
- Physical disability [ Time Frame: one year ] [ Designated as safety issue: No ]
- C-reactive protein [ Time Frame: one year ] [ Designated as safety issue: No ]
- Fatigue [ Time Frame: one year ] [ Designated as safety issue: No ]
| Enrollment: | 280 |
| Study Start Date: | February 2005 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Education: Either coping skills training or arthritis education interventions
|
Behavioral: Coping skills training
8 sessions of pain and stress coping skills training
Behavioral: Arthritis education
8 sessions of learning about rheumatoid arthritis
|
|
Experimental: 2
Writing: Either emotional disclosure writing or health behavior writing
|
Behavioral: Written emotional disclosure
4 sessions of writing about stress
Behavioral: Health behavior writing
4 sessions of writing about various health behaviors
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27708 | |
| Principal Investigator: | Mark A. Lumley, PhD | Wayne State University |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mark A. Lumley, Wayne State University |
| ClinicalTrials.gov Identifier: | NCT00088764 History of Changes |
| Other Study ID Numbers: | NIAMS-122, R01AR049059, 1R01 AR49059 |
| Study First Received: | August 4, 2004 |
| Last Updated: | August 9, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wayne State University:
|
Stress Coping Expressive Writing Self-Efficacy Disclosure |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013