Coping Skills Training for Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Coping Skills Training for Early Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056394
• Other study ID #: Pro00007830
• Secondary ID: R01AR047218NIAMS
• Status: Completed
• Phase: N/A
• Start date: February 2003
• Est. completion date: May 2009

Study information

• Verified date: November 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Comprehensive Coping Skills Training
10 weekly, 80-minute coping skills treatment sessions, followed by a series of six biweekly follow-up telephone calls.
• 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.
• Standard Care
Usual care from participants' rheumatologists but no treatment sessions.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		Measured at Week 10
Primary	Psychological disability		Measured at Week 10
Primary	Physical disability		Measured at Week 10
Secondary	Erythrocyte sedimentation rate		Measured at Week 10
Secondary	Joint tenderness count		Measured at Week 10
Secondary	Grip strength		Measured at Week 10
Secondary	Physician assessment of disease activity		Measured at Week 10
Secondary	C reactive protein		Measured at Week 10