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Home > "C" Clinical Trials Conditions > Coping Skills Training for Early Rheumatoid Arthritis  Coping Skills Training for Early Rheumatoid Arthritis
Coping Skills Training for Early Rheumatoid Arthritis
For Condition: Rheumatoid Arthritis
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 225
Location and Contact Information:
Overall Study Official:
FrancisKeefe, Principal Investigator, Duke University
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Loren Caldwell 919-286-2839
Additional Information:
Study ID Numbers: NIAMS-086; 1R01 AR47218-01A2
Study Start Date: February 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056394
Other Rheumatoid Arthritis Studies:
1. Genetic Registry for Rheumatoid Arthritis
2. A Phase III Study of BMS-188667 in patients with active rheumatoid arthritis and inadequate response to methotrexate
3. dnaJ Peptide for Relieving Rheumatoid Arthritis
4. Coping Skills Training for Early Rheumatoid Arthritis
5. A Phase III study of BMS-188667 in subjects with active rheumatoid arthritis
Related Studies:
Other Rheumatoid Arthritis Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Coping Skills Training for Early Rheumatoid Arthritis
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