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临床试验/NCT03148678
NCT03148678已完成不适用

Scrutinizing and Promoting Mindfulness Via New Technologies: Smartphone-based Assessment and Micro-intervention and Functional Magnetic Resonance Imaging (fMRI) (-Neurofeedback)

University Hospital, Basel, Switzerland2 个研究点 分布在 2 个国家目标入组 84 人开始时间: 2017年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
Blood oxygenation level dependent (BOLD) Signal assessed by MRI

研究概览

简要总结

The overall goal of the outlined study is to scrutinize and to promote mindfulness via new technologies using a combination of smartphone-based assessment and micro-interventions, fMRI and real-time fMRI-neurofeedback.

详细描述

The overall goal of the outlined study is to scrutinize and to promote mindfulness via new technologies using a combination of smartphone-based assessment and micro-interventions, fMRI and real-time fMRI-neurofeedback. More specifically, we aim to i) evaluate whether smartphone-based micro-interventions affect mindfulness, stress, and mood, ii) evaluate whether mindfulness, its neural substrate, and related mental and physiological functions can be modified by training volitional control over brain activity by means of real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF), iii) differentiate neural activation patterns during mindfulness vs. mind wandering.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Right-handedness
  • Ability to participate in study procedures

排除标准

  • Color-Blindness
  • Present or past psychological or psychiatric therapy
  • Presence of cardiovascular disease
  • History of major cerebral injury
  • Medical MRI contraindication

结局指标

主要结局

Blood oxygenation level dependent (BOLD) Signal assessed by MRI

时间窗: On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)

Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging

Subjective mood assessed by Multidimensional Mood State Questionnaire

时间窗: Daily, during smartphone-based micro-interventions (duration: 10 days); on 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last smartphone-based micro-intervention days)

Subjective mood, assessed via Multidimensional Mood State Questionnaire (MDMQ)

Subjective stress reactivity assessed by Visual Analog Scale

时间窗: Daily, during smartphone-based micro-interventions (duration: 10 days); on 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last smartphone-based micro-intervention days)

Subjective stress reactivity, assessed via Visual Analog Scale (VAS)

State mindfulness assessed by State Mindfulness Scale

时间窗: Daily, during smartphone-based micro-interventions (duration: 10 days); on 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last smartphone-based micro-intervention days)

State mindfulness, assessed via State Mindfulness Scale (SMS)

次要结局

  • Working Memory assessed by N-back task test(On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days))
  • Emotional reactivity assessed by emotion recognition task(On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days))
  • Cognitive flexibility assessed by computer version of Wisconsin card sorting Task test(On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days))

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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