Clinical trial NCT00056394: Coping Skills Training for Early Rheumatoid Arthritis
Official title: Coping Skills Training for Early Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Early Rheumatoid Arthritis
Coping Skills Training
Pain
Physical Disability
Psychological Disability
Daily Diary Measures
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2003-03-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Pain
timeFrame: Measured at Week 10
measure: Psychological disability
timeFrame: Measured at Week 10
measure: Physical disability
timeFrame: Measured at Week 10
Secondary outcomes:
measure: Erythrocyte sedimentation rate
timeFrame: Measured at Week 10
measure: Joint tenderness count
timeFrame: Measured at Week 10
measure: Grip strength
timeFrame: Measured at Week 10
measure: Physician assessment of disease activity
timeFrame: Measured at Week 10
measure: C reactive protein
timeFrame: Measured at Week 10
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Francis J. Keefe, PhD
role: PRINCIPAL_INVESTIGATOR
References: