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临床试验/NCT05710250
NCT05710250已完成不适用

The Effects of Mindfulness Meditation on Brain Metabolism in the Limbic Regions Studied by Magnetic Resonance Spectroscopy Correlations With the Memory Performance and Episodic Metamemetory of Students.

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月30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
30
试验地点
1
主要终点
Change from Baseline in Glumatate concentrations (mM) at 8 Weeks

研究概览

简要总结

Stress reduction methods based on mindfulness meditation have been experiencing significant growth in various fields of society over the past twenty years. In the case of students, scientific work has shown that mindfulness training has a positive effect on their mental health and possibly on their academic performance through improved attention and memory. The effect of metamemory ("knowing what you know and what you don't know"), which plays an important part in students memorization and academic success, has not yet been explored.

Changes in brain structure have been noted by MRI in some regions after several weeks of mindfulness training, but very few studies have yet looked at changes in brain metabolism that can be observed by the spectrocopy technique.

The investigators will conduct a prospective randomized study with overall 30 female speech therapists student that will be enrolled and assigned randomly to two groups, in a 1:1 ratio : one groupe that will benefit from mindfulness training and the other group that will benefit from another method of stress reduction based on muscular relaxation.

The programs will extend over 6 weeks with session of 2h30 per week in groups having personnal daily exercices (30-40' per day). During the 3 weeks leading up to and the 2 weeks following the program, students will take tests exploring memory and metamemory, complete mental health questionnaires, and have a magnetic resonance imaging with spectroscopic analysis.

详细描述

The main objective of this study is to investigate the effects of a mindfulness based stress reduction (MBSR) program on the metabolism of regions involved in memorization (several limbic regions : hippocampus, amygdala, anterior and posterior cingulate)

The study also aims to :

  1. Study the effects of MBSR program on memory and metamemory.
  2. Study correlations between MBSR program effects on metamemory and scores on mental health scales (anxiety, depression, perceived stress, burnout)
  3. Study the correlations between MBSR program effects on memory and metamemory with those on attentional capacities, working memory, executive functions and emotion regulation
  4. Investigate the relationship between brain metabolites variations and the effect of the MBSR program on episodic memory and metamemory capacities, attention and emotions
  5. Investigate the relationship between metabolite concentrations variations and variations in volume and thickness of the cortex.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Right-handed
  • ≥ 18 years old
  • Affiliated to a social security scheme
  • Written consent signed by the participan

排除标准

  • Inability to complete the entire study programme
  • Previous participation in an MBSR or MBCT programme
  • Current neurological pathology
  • Current psychiatric pathology, score ≥ 3 on the PHQ-4 self-questionnaire
  • Previous or ongoing psychological or psychiatric treatment
  • Previous or current psychotropic treatment
  • Usual contraindications to brain MRI (including claustrophobia, ocular metallic foreign body, pacemaker, neurostimulator, cochlear implants (or non-removable electronic medical equipment), old generation heart valves, vascular clips previously implanted on a cranial aneurysm).
  • Pregnancy
  • During the exclusion period of a clinical research study
  • Under legal protection or deprived of liberty.

研究组 & 干预措施

Mindfulness based stress reduction (MBSR) program

Experimental

15 students will follow a 6-week MBSR program with 2h30 sessions per week in group and daily exercises lasting 30-40 minutes per day.

干预措施: 6-week MBSR program (Behavioral)

Muscular relaxation program

Active Comparator

15 students will follow a 6-week muscular relaxation program with 2h30 group sessions per week in group and daily exercises lasting 30-40 minutes per day.

干预措施: 6-week muscular relaxation program (Behavioral)

结局指标

主要结局

Change from Baseline in Glumatate concentrations (mM) at 8 Weeks

时间窗: baseline and 8 weeks

Glumatate concentrations (mM) are measured by magnetic resonance spectrocopy in left hippocampal formation

次要结局

  • Change in score of Stroop test(baseline and 8 weeks)
  • Change in score of the number memory task(baseline and 8 weeks)
  • Change in score of N-Back test(Baseline and at 8 weeks)
  • Chang in overall brain volume measured on MRI 3D T1w sequence(baseline and 8 weeks)
  • Change in score of the Hospital Anxiety and Depression Scale (HADS)(baseline and 8 weeks)
  • Change in score of the Columbia Suicide Severity Rating Scale (C-SSRS)(baseline and 8 weeks)
  • Change in score the Feeling of knowing task (FOK task)(baseline and 8 weks)
  • Change in score of the Trail Making Test (TMT)(baseline and 8 weeks)
  • Change in score of attentional network test (ANT)(baseline and 8 weeks)
  • Change in score of the Perceived Stress Scale (PSS)(baseline and 8 weeks)
  • Change in score of the World Health Organization Quality of Life (WHOQOL)(baseline and 8 weeks)
  • Change in posterior cingulate volumes (mm^3) measured on MRI 3D T1w sequence(baseline and 8 weeks)
  • Change in left hippocampal formation volumes (mm^3) measured on MRI 3D T1w sequence(baseline and 8 weeks)
  • Change in right amygdala volumes (mm^3) measured on MRI 3D T1w sequence(baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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