Pain and Stress Management for People With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088764
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : August 15, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: Coping skills training Behavioral: Written emotional disclosure Behavioral: Arthritis education Behavioral: Health behavior writing Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Disclosure and Skills Training for Rheumatoid Arthritis
Study Start Date : February 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Joint count [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Psychological impairment [ Time Frame: one year ]
  2. Pain [ Time Frame: one year ]
  3. Physical disability [ Time Frame: one year ]
  4. C-reactive protein [ Time Frame: one year ]
  5. Fatigue [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088764

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
Sponsors and Collaborators
Wayne State University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Mark A. Lumley, PhD Wayne State University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mark A. Lumley, Professor, Wayne State University Identifier: NCT00088764     History of Changes
Other Study ID Numbers: NIAMS-122
R01AR049059 ( U.S. NIH Grant/Contract )
1R01AR049059 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2004    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013

Keywords provided by Mark A. Lumley, Wayne State University:
Expressive Writing

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases