Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
研究概览
详细说明
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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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General 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:
- Experience of childhood maltreatment
- With current age between 19 to 35 years old
- With current symptoms of depression or anxiety or PTSD or significant general stress.
Exclusion Criteria:
- History of psychiatric disorders with psychotic features
- Suicidal attempts during the past six months
- Neurological disorders
- And common MRI exclusion criteria
- Prior history with the mindfulness based stress reduction program or other systematic meditation programs.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 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：Mindfulness group
This arm receives an 8-week mindfulness based behavioral intervention program.
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The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
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其他：Waitlist control group
This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.
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The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Subjects' Perceived Stress Level
大体时间：After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
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Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed. |
After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes of Mindfulness
大体时间：After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
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Changes in the mindfulness level as measured by the Mindful Attention Awareness Scale (post-intervention scores minus pre-intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The MAAS is a 15-item scale each responded with Likert scale 1-6; the MAAS score calculated as the mean of all items, thus the full range of the score is 1-6, with higher scores meaning more mindful. An increase in MAAS score (i.e., a positive score change )means the subject has improved after the intervention by becoming more mindful. |
After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
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合作者和调查者
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 (实际的)
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 (实际的)
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.
Mindfulness based intervention的临床试验
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Ege Miray Topcu完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University完全的