Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
研究概览
详细说明
The affective self-awareness approach presumes that many chronic pain states, such as fibromyalgia (FM), can be effectively treated by encouraging self-awareness of emotional tension. While anecdotally effective in selected patients, this approach has thus far not been tested in a randomized controlled trial. Our purpose is to determine whether an affective self-awareness approach significantly improves pain, tenderness, and other FM symptoms in a random sample of FM patients; and to determine what psychosocial factors predict a favorable response.
Comparisons: changes in ratings of pain, tenderness, and other symptoms between two arms of the study:
- three weekly 2-hour small-group meetings supplemented with daily writing and meditative exercises to enhance affective self-awareness
- usual care
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Southfield、Michigan、美国、48075
- St. John Providence Hospital
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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:
- fibromyalgia, as defined by American College of Rheumatology 1990 criteria.
- at least 18 years of age.
- have access to transportation to and from Providence Hospital, Southfield, MI.
Exclusion Criteria:
- co-morbid medical conditions capable of causing a worsening of physical functional status independent of FM, including morbid obesity, autoimmune diseases, cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), pregnancy, and malignancy within the preceding 2 years.
- any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), post-traumatic stress disorder, current suicide risk or history of suicide attempt, or substance abuse within 2 years. Note: Subjects with mood or anxiety disorders otherwise will not be excluded.
- changes in medication regimen within one month prior to enrollment.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Workshop
Affective Self Awareness intervention
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Affective Self Awareness intervention: 90 minute face-to-face consultation with the treating physician, then three 2-hour weekly small-group workshops involving education regarding Mind-Body connections, written emotional expression, meditation, and self-affirmation practices.
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无干预：Control
Waiting-list control.
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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 |
|---|---|
|
Change in average pain according to the Brief Pain Inventory
大体时间：6 months
|
6 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
情绪状态概况
大体时间：6个月
|
6个月
|
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Change in Multi-dimensional Fatigue Inventory
大体时间：6 months
|
6 months
|
|
Medical Outcomes Study sleep subscale
大体时间：6 months
|
6 months
|
|
Perceived Stress Scale
大体时间：6 months
|
6 months
|
|
SF-36 Physical Functional Status
大体时间：6 months
|
6 months
|
|
Tender point count
大体时间：6 months
|
6 months
|
|
Dolorimeter tender point score
大体时间：6 months
|
6 months
|
|
Ascending and Multiple Random Staircase thumbnail sensitivity thresholds
大体时间：6 months
|
6 months
|
合作者和调查者
赞助
调查人员
- 首席研究员：Michael C Hsu, MD、University of Michigan Chronic Pain and Fatigue Research Center
出版物和有用的链接
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
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