Coping Skills Training for Early Rheumatoid Arthritis

NCT ID: NCT00056394

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2009-05-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

1

Participants will receive comprehensive pain coping skills.

Group Type: EXPERIMENTAL

Comprehensive Coping Skills Training

Intervention Type: BEHAVIORAL

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

2

Participants will receive arthritis education.

Group Type: ACTIVE_COMPARATOR

Arthritis Education Sessions

Intervention Type: 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.

3

Participants will receive standard care.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

Usual care from participants' rheumatologists but no treatment sessions.

Interventions

Comprehensive Coping Skills Training

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

Intervention Type: BEHAVIORAL

Arthritis 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.

Intervention Type: BEHAVIORAL

Standard Care

Usual care from participants' rheumatologists but no treatment sessions.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis J. Keefe, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

R01AR047218

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAMS-086

Identifier Type: -

Identifier Source: secondary_id

Pro00007830

Identifier Type: -

Identifier Source: org_study_id