Pain and Stress Management for People With Rheumatoid Arthritis
Disclosure and Skills Training for Rheumatoid Arthritis
研究概览
地位
条件
详细说明
Two self-management strategies hold promise for improving the health of people with RA: ED (writing about stress, RA, and coping options) and CST (learning six pain and stress coping skills). A strategy integrating ED with CST may be more effective than either intervention alone. This study will compare the effectiveness of ED, CST, ED in combination with CST, and control groups in alleviating the symptoms of RA.
This study will last until May 2009. Participants with RA will be randomly assigned to 1 of 4 treatment groups. Each participant will receive 3 writing sessions and 8 training sessions. Group 1 will receive ED writing followed by CST; Group 2 will receive ED writing followed by arthritis education; Group 3 will receive health behavior writing followed by CST; and Group 4 will receive health behavior writing followed by arthritis education.
Participants will be evaluated at baseline and at Months 1, 4, and 12 for pain, physical disability, psychological impairment, and disease activity. In addition, participants will record daily diaries for 30 days regarding their pain, symptoms, coping, stress, and mood prior to each of the evaluations. Changes in health status over time will be compared among groups.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Michigan
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Detroit、Michigan、美国、48202
- Wayne State University
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North Carolina
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Durham、North Carolina、美国、27708
- Duke University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Meet American College of Rheumatology (ACR) 1987 criteria for RA
Exclusion Criteria:
- Other disorders that would significantly affect function (e.g., lupus, chronic obstructive pulmonary disease [COPD], congestive heart failure [CHF], cancer)
- Judged by the physician to have cognitive impairment (dementia, retardation, psychosis) or illiteracy
- Has experienced recent (last 6 months) significant stressor resulting in substantial emotional instability
- Currently in psychotherapy or a formal behavioral pain management program
- Unable to walk. Participants who use walking aids are not excluded.
- Physically unable to write
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1
Education: Either coping skills training or arthritis education interventions
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8 sessions of pain and stress coping skills training
8 sessions of learning about rheumatoid arthritis
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实验性的:2
Writing: Either emotional disclosure writing or health behavior writing
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4 sessions of writing about stress
4 sessions of writing about various health behaviors
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Joint count
大体时间:one year
|
one year
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Psychological impairment
大体时间:one year
|
one year
|
Pain
大体时间:one year
|
one year
|
Physical disability
大体时间:one year
|
one year
|
C-reactive protein
大体时间:one year
|
one year
|
Fatigue
大体时间:one year
|
one year
|
合作者和调查者
调查人员
- 首席研究员:Mark A. Lumley, PhD、Wayne State University
出版物和有用的链接
一般刊物
- Kelley JE, Lumley MA, Leisen JC. Health effects of emotional disclosure in rheumatoid arthritis patients. Health Psychol. 1997 Jul;16(4):331-40. doi: 10.1037//0278-6133.16.4.331.
- Somers TJ, Shelby RA, Keefe FJ, Godiwala N, Lumley MA, Mosley-Williams A, Rice JR, Caldwell D. Disease severity and domain-specific arthritis self-efficacy: relationships to pain and functioning in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2010 Jun;62(6):848-56. doi: 10.1002/acr.20127.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Coping skills training的临床试验
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Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
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Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完全的