Disclosure and Skills Training for Rheumatoid Arthritis
Coping skills training
+ Arthritis education
+ Written emotional disclosure
Arthritis+5
+ Arthritis, Rheumatoid
+ Autoimmune Diseases
Summary
Study start date: February 1, 2005
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.280 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Duke University Medical Center
Durham, United States