Virginia Commonwealth University Stress Reduction Study
2022年8月2日 更新者：Virginia Commonwealth University
This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions and reactions to social conflict.
研究概览
详细说明
The full research project will be conducted over approximately 2-3 weeks, and will consist of two data collection sessions, one before and one after a 14-day stress reduction training course conducted via a smartphone that participants provide.
This course entails instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being.
Participants will be randomly assigned to a mindfulness course or a cognitive reappraisal course.
Both of these courses -mindfulness training (MT) and cognitive reappraisal training (RT) - involve expert-facilitated mental wellness techniques.
MT emphasizes mindfulness-based techniques to reduce stress and promote wellbeing, whereas CT emphasizes reframing and reappraisal techniques to reduce stress and promote well-being.
研究类型
介入性
注册 (实际的)
72
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Virginia
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 88年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened)
- Free of major, uncorrected sensory impairments and cognitive deficits
- Free of a certain psychiatric disorders or history thereof; specifically, a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months, report a hospitalization over the last 3 months, report current drug abuse (e.g., recreational drug use, alcohol intake in excess of 2 drinks per day).
- Adults aged 18 - 55 years of age
- Right hand dominant (will not be advertised but screened)
- Personal SmartPhone (Android or iOS operating systems).
- Naive to meditation practice (will not be advertised but screened)
- At least a moderate level of perceived stress (scale score > 5 on the 4-item Perceived Stress Scale (PSS; reflects above-average perceived stress)
Exclusion Criteria:
- left-handed
- are unwilling or unable to complete study assessments or treatments
- report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
- report a hospitalization over the last 3 months
- report current drug abuse (e.g., recreational drug use, smoke more than � pack per day, alcohol intake in excess of 2 drinks per day)
- are prisoners
- no personal SmartPhone (Android or iOS operating systems)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：正念
|
Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone.
Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.
|
|
有源比较器：Cognitive reappraisal
|
Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone.
Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.
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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 |
|---|---|---|
|
Functional near-infrared spectroscopy (fNIRS) hemodynamic signal change
大体时间：Baseline and 16 weeks
|
Proportion of participants who show a statistically significant change in regional specificity, as measured by fNIRS-recorded blood oxygenation representing markers of emotion reactivity and regulation during observation of video stimuli.
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Baseline and 16 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in anger response
大体时间：Baseline and 16 weeks
|
The Anger subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess s the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less anger and more emotion downregulation.
Higher scores would indicate more anger and less emotion downregulation.
|
Baseline and 16 weeks
|
|
Change in disgust response
大体时间：Baseline and 16 weeks
|
The Disgust subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less disgust and more emotion downregulation.
Higher scores would indicate more disgust and less emotion downregulation.
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Baseline and 16 weeks
|
|
Change in fear response
大体时间：Baseline and 16 weeks
|
The Fear subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less fear and more emotion downregulation.
Higher scores would indicate more fear and less emotion downregulation.
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Baseline and 16 weeks
|
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Change in anxiety response
大体时间：Baseline and 16 weeks
|
The Anxiety subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less anxiety and more emotion downregulation.
Higher scores would indicate more anxiety and less emotion downregulation.
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Baseline and 16 weeks
|
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Change in sadness response
大体时间：Baseline and 16 weeks
|
The Sadness subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less sadness and more emotion downregulation.
Higher scores would indicate more sadness and less emotion downregulation.
|
Baseline and 16 weeks
|
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Change in intergroup attitudes
大体时间：Baseline and 16 weeks
|
The Beliefs about Groups survey will be used to assess explicit intergroup attitudes.
Participants answer 4 questions using a scale from 1 to 6. Higher scores indicate poorer attitude outcomes.
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Baseline and 16 weeks
|
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Behavioral willingness to participate in a dyad-based future experiment
大体时间：16 weeks
|
Number of participants who express willingness to participate in a dyad-based future experiment using a scale from 1 to 5. Higher scores indicate greater willingness or preference to participate.
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16 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hadley Rahrig, M.S.、Virginia Commonwealth University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年7月19日
初级完成 (实际的)
2022年7月31日
研究完成 (实际的)
2022年7月31日
研究注册日期
首次提交
2019年12月4日
首先提交符合 QC 标准的
2019年12月4日
首次发布 (实际的)
2019年12月9日
研究记录更新
最后更新发布 (实际的)
2022年8月3日
上次提交的符合 QC 标准的更新
2022年8月2日
最后验证
2022年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- HM20015897
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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不
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