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Completed

NCT Number: NCT00056394

Coping Skills Training for Early Rheumatoid Arthritis

Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health problem. Medical treatments are now being used much earlier in the course of RA, but these treatments do not address the challenges of coping with the early stages of this disease. This study will determine whether a comprehensive coping skills training program can decrease pain, psychological disability, and physical disability in patients with early RA.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University, Durham, North Carolina, United States

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About this study

RA is a serious and complex disease that taxes patients' coping resources. Patients with RA must cope with pain and with major life stresses, including disruptions in their health, work, family, and marital functioning.

Recognition of the morbidity and mortality associated with RA has increased interest in early interventions. Rapid disease progression during the first few years of RA taxes patients' coping efforts. Those who cope well with the early stages of RA can maintain an active and rewarding lifestyle. Those who do not may become depressed, decrease physical activity, and develop a sedentary, restricted lifestyle that contributes to long-term disability and overdependence on family and friends.

This study will evaluate the effectiveness of early coping skills training (CST) to enhance self-efficacy, prepare patients to cope with future pain, and prevent the development of behaviors that may increase long-term psychological distress and physical disability. The comprehensive CST intervention combines traditional CST with CST components tailored to rheumatoid arthritis patients. It is designed to teach traditional coping skills such as attention diversion, cognitive restructuring, and changes in activity to control and decrease pain.

Participants will be randomized to one of three study groups: 1) comprehensive pain coping skills training; 2) arthritis education; or 3) standard care. Study participants assigned to the comprehensive CST and the arthritis education groups will be asked to attend ten weekly, 80-minute treatment sessions. These ten sessions will be followed by a series of six biweekly follow-up telephone calls.

Study participants in the arthritis education group will learn about the nature and treatment of rheumatoid arthritis as well as the benefits of exercise and joint protection. Study participants in the standard care group will continue to receive care from their rheumatologists but will not participate in any treatment sessions.

Measures of pain, disability, pain coping, and self efficacy will be collected during evaluation sessions before and after the treatment phase. Participants attend 5 evaluation sessions and will be followed for 18 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meet at least 4 of the 7 criteria for RA classification based on the 1987 American College of Rheumatology criteria
  • Onset of RA symptoms within 2 years of study entry

Exclusion criteria

  • Known organic disease that significantly affects function
  • Rheumatic disorders in addition to RA that significantly affect function

Treatment and study plan

Comprehensive Coping Skills Training

Behavioral

10 weekly, 80-minute coping skills treatment sessions, followed by a series of six biweekly follow-up telephone calls.

Arthritis Education Sessions

Behavioral

10 weekly, 80-minute treatment sessions, followed by a series of six biweekly follow-up telephone calls. Participants will learn about the nature and treatment of rheumatoid arthritis as well as the benefits of exercise and joint protection.

Standard Care

Behavioral

Usual care from participants' rheumatologists but no treatment sessions.

Primary outcomes

  1. Pain

    Time frame: Measured at Week 10

  2. Psychological disability

    Time frame: Measured at Week 10

  3. Physical disability

    Time frame: Measured at Week 10

Secondary outcomes

  1. Erythrocyte sedimentation rate

    Time frame: Measured at Week 10

  2. Joint tenderness count

    Time frame: Measured at Week 10

  3. Grip strength

    Time frame: Measured at Week 10

  4. Physician assessment of disease activity

    Time frame: Measured at Week 10

  5. C reactive protein

    Time frame: Measured at Week 10

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Mar 12, 2003
Registry last updated
Oct 25, 2018

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.

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