Pain and Stress Management for People With Rheumatoid Arthritis
NCT ID: NCT00088764
Last Updated: 2013-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
280 participants
INTERVENTIONAL
2005-02-28
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Education: Either coping skills training or arthritis education interventions
Coping skills training
8 sessions of pain and stress coping skills training
Arthritis education
8 sessions of learning about rheumatoid arthritis
2
Writing: Either emotional disclosure writing or health behavior writing
Written emotional disclosure
4 sessions of writing about stress
Health behavior writing
4 sessions of writing about various health behaviors
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Coping skills training
8 sessions of pain and stress coping skills training
Written emotional disclosure
4 sessions of writing about stress
Arthritis education
8 sessions of learning about rheumatoid arthritis
Health behavior writing
4 sessions of writing about various health behaviors
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Wayne State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mark A. Lumley
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark A. Lumley, PhD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wayne State University
Detroit, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.