Coping Skills Training for Early Rheumatoid Arthritis

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: Comprehensive Coping Skills Training; Behavioral: Arthritis Education Sessions; Behavioral: Standard Care

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Participants will receive comprehensive pain coping skills.	Behavioral: Comprehensive Coping Skills Training; 10 weekly, 80-minute coping skills treatment sessions, followed by a series of six biweekly follow-up telephone calls.
Active Comparator: 2; Participants will receive arthritis education.	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.
Active Comparator: 3; Participants will receive standard care.	Behavioral: Standard Care; Usual care from participants' rheumatologists but no treatment sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain	Measured at Week 10
Psychological disability	Measured at Week 10
Physical disability	Measured at Week 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Erythrocyte sedimentation rate	Measured at Week 10
Joint tenderness count	Measured at Week 10
Grip strength	Measured at Week 10
Physician assessment of disease activity	Measured at Week 10
C reactive protein	Measured at Week 10

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Francis J. Keefe, PhD, Duke University

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 11, 2003
• First Submitted That Met QC Criteria: March 11, 2003
• First Posted (Estimate): March 12, 2003

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Pain; Early Rheumatoid Arthritis; Physical Disability; Psychological Disability; Coping Skills Training; Daily Diary Measures
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: Pro00007830; R01AR047218 (U.S. NIH Grant/Contract); NIAMS-086