Clinical trial NCT05710250: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavior
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Female

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Glumatate concentrations (mM) at 8 Weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change in left hippocampal formation volumes (mm3) measured on MRI 3D T1w sequence
timeFrame: baseline and 8 weeks
measure: Change in right amygdala volumes (mm3) measured on MRI 3D T1w sequence
timeFrame: baseline and 8 weeks
measure: Change in posterior cingulate volumes (mm3) measured on MRI 3D T1w sequence
timeFrame: baseline and 8 weeks
measure: Chang in overall brain volume measured on MRI 3D T1w sequence
timeFrame: baseline and 8 weeks
measure: Change in score the Feeling of knowing task (FOK task)
timeFrame: baseline and 8 weks
measure: Change in score of the Trail Making Test (TMT)
timeFrame: baseline and 8 weeks
measure: Change in score of Stroop test
timeFrame: baseline and 8 weeks
measure: Change in score of N-Back test
timeFrame: Baseline and at 8 weeks
measure: Change in score of attentional network test (ANT)
timeFrame: baseline and 8 weeks
measure: Change in score of the number memory task
timeFrame: baseline and 8 weeks
measure: Change in score of the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline and 8 weeks
measure: Change in score of the Perceived Stress Scale (PSS)
timeFrame: baseline and 8 weeks
measure: Change in score of the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: baseline and 8 weeks
measure: Change in score of the World Health Organization Quality of Life (WHOQOL)
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University hospital of Tours
name: Jean Philippe COTTIER
role: PRINCIPAL_INVESTIGATOR
References: