Dismantling Mindfulness: Contributions of Attention vs. Acceptance
2018年11月1日 更新者:Willoughby Britton、Brown University
This study addresses NCCAM's request for research that investigates the neuropsychological mechanisms underlying mind-body therapies, and for precise criteria and better delineation of meditation practices.
The purpose of this study is to assess the clinical efficacy and mechanism of action of 2 component practices of "mindfulness meditation", i.e. focused awareness (FA) and open monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based Cognitive Therapy (MBCT).
研究概览
地位
完全的
详细说明
Meditation, particularly mindfulness meditation, is one of the most popular Complementary and Alternative Medicine (CAM) therapies for alleviating emotional stress, depression and anxiety.
While standardized meditation-based treatment packages like Mindfulness Based Stress Reduction (MBSR) and Mindfulness-based Cognitive Therapy (MBCT) have reliably shown sustained improvements in emotional disturbances and wellbeing, they contain so many different components and practices that the active ingredient cannot be ascertained.
What is commonly called "Mindfulness" meditation is actually comprised of two separate practices: 1) focused awareness practice (FA), and 2) open-monitoring practice (OM).
This project aims to create separate 8 week programs for FA and OM meditations, compare their clinical efficacy and investigate their separate mechanisms of action in individuals with clinically significant levels of persistent negative affect and depression.
The clinical benefit and mechanism of action of focused awareness (FA) vs open-monitoring (OM) vs MBCT will be examined with a 3-armed randomized control trial of these 8 week interventions.
Outcome variables include negative affect (depression, anxiety, stress) and wellbeing.
Hypothesized mediating processes include objectively measured attention, emotion regulation and the basic wakefulness on which they depend.
研究类型
介入性
注册 (实际的)
104
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
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Rhode Island
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Providence、Rhode Island、美国、02912
- Brown University Clinical and Affective Neuroscience Laboratory
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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 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- English-speaking
- ages 18-65
- mild-severe levels of depression or high level of negative affect
Exclusion Criteria:
Current:
- age <18 or >65
- inability to read and write in English
- Extremely severe levels of depression
- active suicidal ideation
- presence of Axis I personality disorder
- panic disorder
- post-traumatic stress disorder
- obsessive-compulsive disorder
- eating disorder, or substance abuse/dependence
- current psychotherapy
- change in antidepressant medication type or dosage in the last 8 weeks.
Lifetime history exclusions:
- bipolar disorder
- psychotic disorders
- persistent antisocial behavior or repeated self-harm,
- borderline personality disorder,
- organic brain damage
- regular meditation practice
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:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Focused Attention (FA)
This 8 week program consists solely of focused attention practices, i.e. selected attention to an object (breath etc) and deselection of other stimuli
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实验性的:Open-Monitoring (OM)
This 8-week program consists solely of open monitoring practices, or noticing and/or labeling the contents of ongoing experience ( thoughts, body sensations, emotions, seeing, hearing etc) without focusing on or deselecting any stimuli
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实验性的:Mindfulness-Based Cognitive Therapy (MBCT)
The 8 week MBCT program follows the 2nd Edition (2012) manual (Segal, Williams, Teasdale) and includes both focused attention and open- monitoring practices
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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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Change in Inventory of Depressive Symptomatology
大体时间:baseline, 8 weeks, 20 weeks
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30-item clinician administered interview about unipolar depression symptoms
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baseline, 8 weeks, 20 weeks
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change in Depression, Anxiety Stress Scale (DASS)
大体时间:baseline, week 2,4,6,8, 20
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42-item self-report questionnaire on depression, anxiety and stress symptoms
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baseline, week 2,4,6,8, 20
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change in Wellbeing Scale (WBS)
大体时间:baseline, 8 weeks, 20 weeks
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73-item self-report questionnaire of psychological wellbeing
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baseline, 8 weeks, 20 weeks
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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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Change in alpha-theta EEG power from baseline to 8 weeks
大体时间:baseline and 8 weeks
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Resting/spontaneous EEG power in 5-9 Hz range
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baseline and 8 weeks
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Change in Facial EMG power from baseline to 8 weeks
大体时间:baseline and 8 weeks
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Facial EMG response to emotional (IAPS) photos (reactivity + regulation)
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baseline and 8 weeks
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Sustained Attention to response Task (SART)
大体时间:baseline, 8 weeks
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40 minuted sustained attention, go-no-go task
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baseline, 8 weeks
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Difficulties in Emotion Regulation Scale (DERS)
大体时间:baseline, 8 weeks, 20 weeks
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36-item self report of emotion regulation
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baseline, 8 weeks, 20 weeks
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Attention Control Questionnaire (Derryberry & Reed, 2002)
大体时间:baseline, 8 weeks, 20 weeks
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20-item self report measure of attentional abilities
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baseline, 8 weeks, 20 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Five Facet Mindfulness Questionnaire (FFMQ)
大体时间:baseline, week 3,5,7,8,20
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39-item self-report questionnaire of mindfulness skill acquisition (attention, non-reactivity)
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baseline, week 3,5,7,8,20
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Self-Compassion Scale (Neff 2003)
大体时间:baseline, 8 weeks, 20 weeks
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26-item self report of attitudes towards oneself
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baseline, 8 weeks, 20 weeks
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Positive and Negative Affect Scale (PANAS)
大体时间:week 1,2,3,4,5,6,7,8
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60-item self report of emotional states
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week 1,2,3,4,5,6,7,8
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Cullen B, Eichel K, Lindahl JR, Rahrig H, Kini N, Flahive J, Britton WB. The contributions of focused attention and open monitoring in mindfulness-based cognitive therapy for affective disturbances: A 3-armed randomized dismantling trial. PLoS One. 2021 Jan 12;16(1):e0244838. doi: 10.1371/journal.pone.0244838. eCollection 2021.
- Canby NK, Eichel K, Peters SI, Rahrig H, Britton WB. Predictors of Out-of-Class Mindfulness Practice Adherence During and After a Mindfulness-Based Intervention. Psychosom Med. 2021 Jul-Aug 01;83(6):655-664. doi: 10.1097/PSY.0000000000000873.
- Britton WB, Davis JH, Loucks EB, Peterson B, Cullen BH, Reuter L, Rando A, Rahrig H, Lipsky J, Lindahl JR. Dismantling Mindfulness-Based Cognitive Therapy: Creation and validation of 8-week focused attention and open monitoring interventions within a 3-armed randomized controlled trial. Behav Res Ther. 2018 Feb;101:92-107. doi: 10.1016/j.brat.2017.09.010. Epub 2017 Sep 28.
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
2013年2月1日
初级完成 (实际的)
2016年3月15日
研究完成 (实际的)
2016年3月15日
研究注册日期
首次提交
2013年4月10日
首先提交符合 QC 标准的
2013年4月11日
首次发布 (估计)
2013年4月15日
研究记录更新
最后更新发布 (实际的)
2018年11月5日
上次提交的符合 QC 标准的更新
2018年11月1日
最后验证
2018年11月1日
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.