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临床试验/NCT00056394
NCT00056394已完成不适用

Coping Skills Training for Early Rheumatoid Arthritis

Duke University4 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2003年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
4
主要终点
Pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

Participants will receive comprehensive pain coping skills.

干预措施: Comprehensive Coping Skills Training (Behavioral)

2

Active Comparator

Participants will receive arthritis education.

干预措施: Arthritis Education Sessions (Behavioral)

3

Active Comparator

Participants will receive standard care.

干预措施: Standard Care (Behavioral)

结局指标

主要结局

Pain

时间窗: Measured at Week 10

Psychological disability

时间窗: Measured at Week 10

Physical disability

时间窗: Measured at Week 10

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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