Skip to main content
OpenTrials
Completed

NCT Number: NCT00088764

Pain and Stress Management for People With 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wayne State University, Detroit, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coping Skills Training

Behavioral

8 sessions of pain and stress coping skills training

Written emotional disclosure

Behavioral

4 sessions of writing about stress

Arthritis education

Behavioral

8 sessions of learning about rheumatoid arthritis

Health behavior writing

Behavioral

4 sessions of writing about various health behaviors

Primary outcomes

  1. Joint count

    Time frame: one year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Disclosure and Skills Training for Rheumatoid Arthritis

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Aug 5, 2004
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.