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临床试验/NCT02413177
NCT02413177已完成不适用

Augmenting Mindfulness Training Through Experience-driven Neurofeedback

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
2
主要终点
percent signal change in the PCC as assessed by fMRI

研究概览

简要总结

The overall goal of the proposed study is to develop and test real time neurofeedback (EEG-RTNF) as a tool to augment Mindfulness Based Stress Reduction (MBSR). This study is based on the theoretical model that (1) mind-wandering and self-referential processing are associated with stress, (2) meditation redirects the wandering mind toward present-centered awareness, (3) meditation also decreases activity in hubs of the default mode network (DMN) involved in mind-wandering and self-referential processing, and thus (4) meditation leading to decreased activity in these hubs should lead to reduced stress and improved health and well-being. Milestones include: (1) test whether EEG-RTNF from the PCC during meditation augments MBSR in novices; and (2) test whether MBSR with EEG-RTNF from the PCC leads to real-world outcomes in reduced stress and improved attention.

详细描述

Mindfulness Based Stress Reduction (MBSR) is an effective intervention for promoting positive cognitive and behavioral changes for improved health. However, MBSR delivery may be suboptimal. Recent work on potential neural mechanisms underlying the meditation practices that are core to MBSR may be utilized to improve MBSR delivery and efficacy. The investigators have shown recently that the posterior cingulate cortex (PCC), a brain region implicated in anxiety, addiction, Alzheimer's, ADHD, and other medical maladies, is selectively deactivated during three meditation practices that are core to MBSR suggesting a central role for the PCC in the neurobiology of MBSR. The investigators have also recently confirmed that PCC deactivation corresponds with the subjective experience of meditation in meditators. The proposed study will use EEG-RTNF from the PCC during meditation as an innovative strategy to augment MBSR and improve outcomes.

The task of mindfulness-the principle component of MBSR-is to maintain attention on and acceptance toward present-moment experience, and to redirect attention to one's immediate experience when it has strayed. This present-centered awareness may be considered a counterpoint to self-referential processing and mind-wandering. Consistent with a role for the PCC in mind-wandering, the PCC is specifically deactivated during three meditation practices (mindfulness of the breath, loving-kindness, and choiceless awareness) in experienced meditators compared to novices). Supporting these findings, a research study. showed that PCC deactivation during meditation correlated with a behavioral measure of attention (the Rapid Visual Information Processing Task, RVIP) in experienced meditators, suggesting that PCC deactivation is associated with improved attention in meditators. Another research study showed that the PCC is deactivated when experienced meditators mindfully view emotional images suggesting that PCC deactivation is associated with emotional stability and enhanced present-moment awareness.

EEG-RTNF is an emerging technology similar to classic biofeedback in which individuals receive moment-to-moment feedback of their brain activity during a particular task, typically by a dynamic visual display (e.g., a graph).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • English speakers (due to instructions provided in English)
  • No history of neurological disorder
  • Ability to understand the study procedures and willingness to commit to the demands of the study protocol.
  • Remaining in the area for the duration of the study
  • Willing to be randomized

排除标准

  • Prior participation in an MBSR course.
  • Regular meditation practice (or any other form of meditative practice, such as yoga, Tai Chi or contemplative prayer) for more than an average of 20 minutes a week within the past 2 years
  • Participants with a serious psychiatric, cognitive or medical disorder which could interfere with completion of the study
  • Unstable dose of psychotropic medication. Participants must be on a stable dose for the past three months
  • Use of antipsychotic medication or stimulants
  • Current alcohol use (>14/week or >4 drinks at any one time for a male, or >7 drinks/week or >3 drinks at any one time for a female)
  • Substance abuse (high frequency and problems caused) or dependence in the past 6 months;
  • Claustrophobia
  • MRI incompatible implants

研究组 & 干预措施

EEG-RTNF

Active Comparator

Group 1 will receive EEG-RTNF training from the PCC. They will attend an 8 week MBSR class. This feedback will occur at weeks 3, 4, 6 and 7.

干预措施: EEG-RTNF (Behavioral)

EEG-no RTNF

Active Comparator

Group 2 will receive EEG (no RTNF feedback). They will attend an 8 week MBSR class. This feedback will occur at weeks 3, 4, 6 and 7.

干预措施: EEG-no RTNF (Behavioral)

结局指标

主要结局

percent signal change in the PCC as assessed by fMRI

时间窗: 12 weeks

will demonstrate that EEG-RTNF from the PCC augments MBSR as assessed by PCC deactivation during meditation

次要结局

  • Rapid Visual Information Processing (RVIP): %hits,(5 and a half month)
  • Rapid Visual Information Processing (RVIP): % of misses(5 and a half month)
  • Patient Recorded Outcomes Measurement Information System (PROMIS)- 29 question scores(5 and a half month)
  • Perceived stress scale (PSS) questionnaire scores,(5 and a half month)
  • Rapid Visual Information Processing (RVIP): reaction time in milliseconds to hits(5 and a half month)
  • Rapid Visual Information Processing (RVIP): number of false alarms(5 and a half month)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Judson Brewer

Associate Professor, Medicine and Psychiatry

University of Massachusetts, Worcester

研究点 (2)

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