Coping Skills Training for Early Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT00056394|
Recruitment Status : Completed
First Posted : March 12, 2003
Last Update Posted : October 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Behavioral: Comprehensive Coping Skills Training Behavioral: Arthritis Education Sessions Behavioral: Standard Care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Coping Skills Training for Early Rheumatoid Arthritis|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
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.
- Pain [ Time Frame: Measured at Week 10 ]
- Psychological disability [ Time Frame: Measured at Week 10 ]
- Physical disability [ Time Frame: Measured at Week 10 ]
- Erythrocyte sedimentation rate [ Time Frame: Measured at Week 10 ]
- Joint tenderness count [ Time Frame: Measured at Week 10 ]
- Grip strength [ Time Frame: Measured at Week 10 ]
- Physician assessment of disease activity [ Time Frame: Measured at Week 10 ]
- C reactive protein [ Time Frame: Measured at Week 10 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056394
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Francis J. Keefe, PhD||Duke University|