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
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Behavioral: Coping skills training
Behavioral: Written emotional disclosure
Behavioral: Arthritis education
Behavioral: Health behavior writing
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Disclosure and Skills Training for Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Joint count [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 280
Study Start Date: February 2005
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088764

Locations
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
Investigators
Principal Investigator: Mark A. Lumley, PhD Wayne State University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark A. Lumley, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00088764     History of Changes
Other Study ID Numbers: NIAMS-122, R01AR049059, 1R01 AR49059
Study First Received: August 4, 2004
Last Updated: August 13, 2013
Health Authority: United States: Federal Government

Keywords provided by Wayne State University:
Stress
Coping
Expressive Writing
Self-Efficacy
Disclosure

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

ClinicalTrials.gov processed this record on September 18, 2014