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临床试验/NCT03466164
NCT03466164已完成不适用

Neural Mechanisms of Mindfulness: a Discordant Twin Design

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Change in proactive cognitive control composite behavioral score

研究概览

简要总结

This project focuses on understanding the cognitive and neural mechanisms by which mindfulness training (MT) results in positive behavioral change and enhanced psychological well-being. Participants will complete two sets of cognitive tasks during functional magnetic resonance imaging (fMRI) and either be assigned to an MT intervention between scan sets or after scan sets.

详细描述

This project focuses on understanding the cognitive and neural mechanisms by which mindfulness training (MT) results in positive behavioral change and enhanced psychological well-being. Although MT is rapidly gaining in popularity as a life-style intervention, there are still critical gaps in our understanding of its primary mechanism of action. Current theoretical frameworks suggest that MT operates by improving attentional control, emotional regulation, and self-awareness capabilities, potentially by targeting neuroplastic brain mechanisms of executive control. This suggests an important role for cognitive neuroscience research, but current work is still in its infancy, and subject to a number of well-recognized methodological and conceptual limitations. The proposed project aims to systematically remedy these limitations of prior MT research, by leveraging the unique opportunities offered by the Human Connectome Project (HCP), and on-going NIH R01-funded research. A key feature of the project is the use of a randomized, longitudinal discordant twin design, in which monozygotic (MZ; identical) twin pairs will be recruited, with one co-twin randomly assigned to the MT condition (mindfulness-based stress reduction, or MBSR; the most-validated and standardized form of MT instruction) and the other serving as a (wait-list) control. Each co-twin will undergo extensive behavioral and MRI neuroimaging assessments in a pre/post fashion, before and after the MT (or no-contact control) intervention, to test for specific MT-related effects. The discordant twin design, though never previously employed in an MT context, is widely recognized as one of the strongest for causal inference, since it avoids many of the challenges and confounds associated with inadequately matched control groups, and enables twin-pair focused analyses, which greatly increase statistical power. The investigators will use this design to investigate theoretically-focused hypotheses that stem from a guiding framework regarding the neural mechanisms of cognitive control. Specifically, using a newly developed cognitive control task battery, the investigator will test the counter-intuitive hypothesis that MT produces an enhancement in the neural mechanism and circuits associated with reactive (rather than proactive) control. An additional subset of MZ twin participants will undergo retesting with the original HCP protocol, in order to provide a comprehensive assessment and comparison of MT effect sizes across multiple domains of cognitive and brain function. Success in this project will have high relevance for public health, by providing innovative experimental tools and a novel theoretical framework from which to empirically evaluate and better understand the potential impact of MT programs as lifestyle interventions for enhancing psychological well-being in healthy populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
22 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • monozygotic (MZ) or dizygotic (DZ) twins
  • age range 22 to 45 years
  • native English speaker

排除标准

  • current psychiatric diagnosis
  • taking psychoactive medication
  • medical disorder that affects cognitive or motor function
  • present or past head injury with documented neurological sequelae, and/or causing loss of consciousness.
  • Pregnancy
  • Claustrophobia
  • Metallic objects
  • Heart rhythm abnormalities or pacemaker
  • Premature birth (before 34 weeks)

结局指标

主要结局

Change in proactive cognitive control composite behavioral score

时间窗: Baseline (0 months), Post (through study completion, an average of 3 months)

The proactive composite variable consists aggregates the proactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from their behavioral performance score: \[(participant score - mean)/standard/deviation\]. Then the composite score is created by summing z-scores.

Change in reactive cognitive control composite behavioral score

时间窗: Baseline (0 months), Post (through study completion, an average of 3 months)

The reactive composite variable consists aggregates the reactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from their behavioral performance score : \[(participant score - mean)/standard/deviation\]. Then the composite score is created by summing z-scores.

Change in reactive cognitive control composite brain imaging activation score

时间窗: Baseline (0 months), Post (through study completion, an average of 3 months)

The reactive composite variable consists aggregates the reactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from the brain activation score in the region of interest (ROI): \[(participant score - mean)/standard/deviation\]. Then the composite score is created by summing z-scores.

Change in proactive cognitive control composite brain imaging activation score

时间窗: Baseline (0 months), Post (through study completion, an average of 3 months)

The proactive composite variable consists aggregates the proactive condition of 4 tasks (Stroop, Cued Task-Switching, AX-CPT, Sternberg WM). For each task, a z-score is computed for each participant from the brain activation score in the region of interest (ROI): \[(participant score - mean)/standard/deviation\]. Then the composite score is created by summing z-scores.

次要结局

  • Mindfulness(Baseline (0 months), Post (through study completion, an average of 3 months))
  • Positive and Negative Mood(Baseline (0 months), Post (through study completion, an average of 3 months))
  • Psychological well-being(Baseline (0 months), Post (through study completion, an average of 3 months))
  • Anxiety(Baseline (0 months), Post (through study completion, an average of 3 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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