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Coping Skills Training for Early Rheumatoid Arthritis

Coping Skills Training for Early Rheumatoid Arthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00056394
Enrollment
105
Registered
2003-03-12
Start date
2003-02-28
Completion date
2009-05-31
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Early Rheumatoid Arthritis, Coping Skills Training, Pain, Physical Disability, Psychological Disability, Daily Diary Measures

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALComprehensive Coping Skills Training

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

BEHAVIORALArthritis Education Sessions

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.

BEHAVIORALStandard Care

Usual care from participants' rheumatologists but no treatment sessions.

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
PainMeasured at Week 10
Psychological disabilityMeasured at Week 10
Physical disabilityMeasured at Week 10

Secondary

MeasureTime frame
Physician assessment of disease activityMeasured at Week 10
Erythrocyte sedimentation rateMeasured at Week 10
C reactive proteinMeasured at Week 10
Joint tenderness countMeasured at Week 10
Grip strengthMeasured at Week 10

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026