Pain and Stress Management for People With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Disclosure and Skills Training for Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: Coping skills training
* Behavioral: Written emotional disclosure
* Behavioral: Arthritis education
* Behavioral: Health behavior writing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Education: Either coping skills training or arthritis education interventions | Behavioral: Coping skills training<br>* 8 sessions of pain and stress coping skills training<br>Behavioral: Arthritis education<br>* 8 sessions of learning about rheumatoid arthritis<br>|
| Experimental: 2<br>Writing: Either emotional disclosure writing or health behavior writing | Behavioral: Written emotional disclosure<br>* 4 sessions of writing about stress<br>Behavioral: Health behavior writing<br>* 4 sessions of writing about various health behaviors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint count |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological impairment |  | one year | 
| Pain |  | one year | 
| Physical disability |  | one year | 
| C-reactive protein |  | one year | 
| Fatigue |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Coping, Expressive Writing, Self-Efficacy, Disclosure