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Coping Skills Training for Early Rheumatoid Arthritis

This study is currently recruiting patients.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

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.

Condition Treatment or Intervention
Rheumatoid Arthritis
 Behavior: Comprehensive Coping Skills Training

MedlinePlus related topics:  Rheumatoid Arthritis

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  225

Study start: February 2003

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Exclusion Criteria


Location and Contact Information


North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Loren Caldwell, BA  919-286-2839  Ext. 288    caldw027@mc.duke.edu 
Sandra J. Waters, PhD  919-286-2839  Ext. 228    water017@mc.duke.edu 
Francis J. Keefe, PhD,  Principal Investigator

Study chairs or principal investigators

Francis J. Keefe, PhD,  Principal Investigator,  Duke University   

More Information

Study ID Numbers:  NIAMS-086; 1R01 AR47218-01A2
Record last reviewed:  September 2004
Record first received:  March 11, 2003
ClinicalTrials.gov Identifier:  NCT00056394
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08
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