跳至主要内容
临床试验/NCT05020301
NCT05020301已完成不适用

Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月20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
入组人数
40
试验地点
1
主要终点
CSF pulsation index

研究概览

简要总结

The purpose of this study is to investigate functional brain network in altered meditation state with multimodal neuroimaging.

详细描述

  1. Recruiting participants by approaching mindfulness training, poster, and websites.
  2. Completing Questionnaires, Tests, and other materials for experiments.
  3. Examining Functional Brain Network of Internal and External Meditation of practitioners with a meditation using multimodal neuroimaging.
  4. Collecting and evaluating data about the connection of internal and external meditation with multimodal neuroimaging and identifying the function related to meditation state.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, 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

  • A sufficient level of education to understand study procedure and be able to communicate with site personnel.
  • 18-60 years old.
  • Interested in meditation.
  • No metal or electronic implants in the body; no prosthesis (metal braces, dentures, etc.); no claustrophobia; no tattoos, piercings, etc.; no makeup on the day of the experiment.
  • Right-handed.

排除标准

  • The participant has a contraindication to MRI examination, such as claustrophobia.
  • The participant is physically unfit for MRI, such as having a metal implant.
  • The participant has a history of neurological or psychiatric disorders, or is taking any chronic medications that may interfere with the experiment.

研究组 & 干预措施

Novice meditators

Experimental

Participants who have no meditation practice in the previous year and less than 20 entire lifetime hours' meditation.

干预措施: internal meditation guided audio (Device)

Experienced meditators

Experimental

Participants with more than two years of mindfulness practice

干预措施: external meditation guided audio (Device)

Experienced meditators

Experimental

Participants with more than two years of mindfulness practice

干预措施: internal meditation guided audio (Device)

Novice meditators

Experimental

Participants who have no meditation practice in the previous year and less than 20 entire lifetime hours' meditation.

干预措施: external meditation guided audio (Device)

结局指标

主要结局

CSF pulsation index

时间窗: Week 2

CSF pulsation index, calculated by the number of CSF pulsation per minute.

The cognitive flexibility examined by Cognitive Flexibility Inventory(CFI) after the 1-week practice of internal and external mindfulness

时间窗: Week 2

CFI is a validated, self-reported measure of cognitive flexibility,which consists of 20 statements scored from 1 ( "definitely disagree") to 7( "definitely agree."). The scores for all items are pooled to generate a total score of 20 to 140. Higher total scores indicate the increasing level of cognitive flexibility.

The ability of self-compassion examined by Self-Compassion Scale(SCS) after 1-week practice of internal and external mindfulness

时间窗: Week 2

SCS is a validated, 26-item self-report measure on which the items are scored using a five-point Likert scale scored from 1 (almost never) to 5 (almost always). The higher total score on the scale indicates a higher level of self-compassion.

Functional connectivity

时间窗: Week 2

Checking functional connectivity in major resting-state brain networks (such as DMN).

Mindfulness positive awareness examined by Mindful Attention Awareness Scale (MAAS), Five Facet Mindfulness Questionnaire(FFMQ), The Chinese version of Freiburg Mindfulness Inventory(FMI-13) after the 1-week practice of internal and external mindfulness

时间窗: Week 2

MAAS is a validated, fifteen-item self-report measure on which the items are scored using a six-point rating scale (1 = almost always and 6 = almost never). The global score of the scale is obtained by calculating the mean score of each participant's responses, and higher scores on the scale convey the higher levels of dispositional mindfulness. FFMQ is a validated, self-administered questionnaire that measures the tendency to act with mindfulness. Its 39 items are assessed on a Likert scale from 1 to 5 (i.e., "never or very rarely true" to "very often or always true"). The higher scores on the scale convey the higher tendency to act with mindfulness. FMI-13 is a validated, thirteen-item self-report measure on which the items are scored using a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). This short form was used for measuring mindfulness traits, and higher scores on the scale convey the higher levels of mindfulness trait.

The mental states examined by Brief Profile of Mood States(Brief-POMS), Perceived Stress Scale(PSS) after the 1-week practice of internal and external mindfulness

时间窗: Week 2

The Brief-POMS is a validated,30-item measure, with items scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The scores for all items are pooled to generate a total score in the range of 0 to 120. A higher total score on the scale indicates a worse mood state. PSS is a validated, self-reported measure of psychological stress level. There are 10-items scored from 0 (never) to 4 (very often). The scores for all items are pooled to generate a total score in the range of 0 to 40. Higher total scores indicate the increasing level of psychological stress.

Cognitive impairment quantitative assessment by Mini-Mental State Examination(MMSE)

时间窗: Week 2

MMSE is a validated, widely used screening tool for cognitive impairment quantitative assessment. It included 11 items. The scores for all items are pooled to generate a total score in the range of 0 to 30. A 27-point was proved to be an appropriate cutoff for cognitive impairment in a population with relatively high educational attainment.

Intelligence assessment by Raven's Standard Progressive Matrices (SPM)

时间窗: Week 2

SPM is a validated intelligence assessment that consists of 60 non-colored diagrammatic puzzles with a missing part, which subjects should correctly choose one among six options. SPM scores were estimated as the total of participants' correct answers (0-60). Higher total scores indicate the increasing level of intelligence level.

Mental flexibility assessment by Trail Making Test (TMT)

时间窗: Week 2

TMT is a validated mental flexibility assessment consisting of two parts (TMT-A and TMT-B ). The TMT-A consisted of a standardized page on which the numbers 1 to 25 were scattered within circles. The participants were asked to connect the numbers in order as quickly as possible. Similarly, the TMT-B consisted of a standardized page that included the numbers 1 to 13 and the letters A to L, which were randomly distributed. The participants were instructed to draw lines connecting numbers and letters (ascending and alphabetical) in alternating numbers and letters. A maximum time of 300 s was allowed before discontinuing the test. Direct scores of TMT were the time in seconds taken to complete each task (A and B). A Higher result indicates a worse cognitive outcome.

Five Facet Mindfulness Questionnaire(FFMQ)

时间窗: Week 1

FFMQ is a validated, self-administered questionnaire that measures the tendency to act with mindfulness. Its 39 items are assessed on a Likert scale from 1 to 5 (i.e., "never or very rarely true" to "very often or always true"). The higher scores on the scale convey the higher tendency to act with mindfulness.

CSF pulsation index

时间窗: Week 1

CSF pulsation index, calculated by the number of CSF pulsation per minute.

Functional connectivity

时间窗: Week 1

Checking functional connectivity in major resting-state brain networks (such as DMN).

次要结局

  • Mindfulness positive awareness examined by Mindful Attention Awareness Scale (MAAS)(Week 1)
  • The ability of self-compassion examined by Self-Compassion Scale(SCS) after 1-week practice of internal and external mindfulness(Week 1)
  • Cognitive Flexibility Inventory(CFI)(Week 1)
  • Perceived Stress Scale(PSS)(Week 1)
  • The Chinese version of Freiburg Mindfulness Inventory(FMI-13)(Week 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验