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Coping Skills Training for Early Rheumatoid Arthritis

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Duke University

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Behavioral: Comprehensive Coping Skills Training
Behavioral: Arthritis Education Sessions
Behavioral: Standard Care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00056394
Pro00007830
NIAMS-086
R01AR047218 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

105 participants in 3 patient groups

1
Experimental group
Description:
Participants will receive comprehensive pain coping skills.
Treatment:
Behavioral: Comprehensive Coping Skills Training
2
Active Comparator group
Description:
Participants will receive arthritis education.
Treatment:
Behavioral: Arthritis Education Sessions
3
Active Comparator group
Description:
Participants will receive standard care.
Treatment:
Behavioral: Standard Care

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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