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Pain and Stress Management for People With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University
ClinicalTrials.gov Identifier:
NCT00088764
First received: August 4, 2004
Last updated: August 13, 2013
Last verified: August 2013

August 4, 2004
August 13, 2013
February 2005
April 2009   (final data collection date for primary outcome measure)
Joint count [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Joint count
  • pain
  • physical disability
  • psychological impairment
  • C-reactive protein
Complete list of historical versions of study NCT00088764 on ClinicalTrials.gov Archive Site
  • 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 ]
  • RA flares
  • medication use
  • fatigue
  • morning stiffness
Not Provided
Not Provided
 
Pain and Stress Management for People With Rheumatoid Arthritis
Disclosure and Skills Training for Rheumatoid Arthritis

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Rheumatoid Arthritis
  • Behavioral: Coping skills training
    8 sessions of pain and stress coping skills training
  • Behavioral: Written emotional disclosure
    4 sessions of writing about stress
  • Behavioral: Arthritis education
    8 sessions of learning about rheumatoid arthritis
  • Behavioral: Health behavior writing
    4 sessions of writing about various health behaviors
  • Experimental: 1
    Education: Either coping skills training or arthritis education interventions
    Interventions:
    • Behavioral: Coping skills training
    • Behavioral: Arthritis education
  • Experimental: 2
    Writing: Either emotional disclosure writing or health behavior writing
    Interventions:
    • Behavioral: Written emotional disclosure
    • Behavioral: Health behavior writing

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
June 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00088764
NIAMS-122, R01AR049059, 1R01 AR49059
Yes
Mark A. Lumley, Wayne State University
Wayne State University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Mark A. Lumley, PhD Wayne State University
Wayne State University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP