Pain and Stress Management for People With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Disclosure and Skills Training for Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088764
• Other study ID #: NIAMS-122
• Secondary ID: R01AR0490591R01A
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2004
• Last updated: August 13, 2013
• Start date: February 2005
• Est. completion date: June 2009

Study information

• Verified date: August 2013
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kelley JE, Lumley MA, Leisen JC. Health effects of emotional disclosure in rheumatoid arthritis patients. Health Psychol. 1997 Jul;16(4):331-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint count		one year	No
Secondary	Psychological impairment		one year	No
Secondary	Pain		one year	No
Secondary	Physical disability		one year	No
Secondary	C-reactive protein		one year	No
Secondary	Fatigue		one year	No