BehaviorMEMOREMNCT05710250
The Effects of Mindfulness Meditation on Brain Metabolism in the Limbic Regions Studied by Magnetic Resonance Spectroscopy
A study testing 6-week MBSR program and 6-week muscular relaxation program in people with Behavior, run by University Hospital, Tours at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- 6-week MBSR program and 6-week muscular relaxation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2023to 18 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Right-handed
- ≥ 18 years old
- Affiliated to a social security scheme
- Written consent signed by the participan
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
Read the 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 :
- Study the effects of MBSR program on memory and metamemory.
- Study correlations between MBSR program effects on metamemory and scores on mental health scales (anxiety, depression, perceived stress, burnout)
- Study the correlations between MBSR program effects on memory and metamemory with those on attentional capacities, working memory, executive functions and emotion regulation
- Investigate the relationship between brain metabolites variations and the effect of the MBSR program on episodic memory and metamemory capacities, attention and emotions
- Investigate the relationship between metabolite concentrations variations and variations in volume and thickness of the cortex.
- Conditions
- Behavior
- Being tested
- 6-week MBSR program, 6-week muscular relaxation program
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-week MBSR programBehavioural
Participants will follow a 6-week program of mindfulness meditation. MBSR teaches mindfulness meditation and mindful yoga exercises to develop non-judgmental awareness of moment-to-moment experience. The intervention duration is 6 weeks, with weekly two and half hours sessions. It will be delivered according to the fundamental concepts and specific techniques provided in the MBSR manualized protocol by Kabat-Zinn. The program also includes 30-min daily homework exercises.
MBSR teaches four main mindfulness practices: (1) body scan, a process of moving attention through the body; (2) mindful movement, consisting of gentle yoga stretches to develop awareness of body in movement; (3) sitting meditation; and (4) walking meditation. Inquiry and didactic teaching is also a part of MBSR and allows for some detailed exploration of participants' experiences.
6-week muscular relaxation programBehavioural
Control group : This group will follow a 6-week program of progressive muscle relaxation training in order to learn achieving a deep relaxation of the body through voluntary tensing and relaxing muscles. It proceeds by the individual sequentially tensing and then releasing specific groups of muscles throughout the body, and noticing how tension feels relative to relaxation.
The accomplishment of physical relaxation promotes mental calmness in a parallel manner. This program is based on the work of Bernstein and Borkovec and Jacobson, and will be structured in 6-week group with weekly two and half hours sessions and out-of-session assignments for at-home practice (30-min daily).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 6-week MBSR program |
| 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. Receives: Behavioral: 6-week muscular relaxation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Glumatate concentrations (mM) at 8 Weeks
Glumatate concentrations (mM) are measured by magnetic resonance spectrocopy in left hippocampal formation
Measured: baseline and 8 weeks
Secondary outcomes (14)
Change in left hippocampal formation volumes (mm^3) measured on MRI 3D T1w sequence
Measured: baseline and 8 weeks
Change in right amygdala volumes (mm^3) measured on MRI 3D T1w sequence
Measured: baseline and 8 weeks
Change in posterior cingulate volumes (mm^3) measured on MRI 3D T1w sequence
Measured: baseline and 8 weeks
Chang in overall brain volume measured on MRI 3D T1w sequence
Measured: baseline and 8 weeks
Change in score the Feeling of knowing task (FOK task)
FOK task for episodic memory performance includes 4 distincts steps : (1) a learning phase of a 60 pairs of words, (2) a cued recall phase (number of correct recalls /60 ; number of incorrect recalls /60), (3) feeling of knowing phase, (4) recognition phase (number of correct recognition /60 ; number of incorrect recognition /60)
Measured: baseline and 8 weks
Change in score of the Trail Making Test (TMT)
TMT consists of two parts. In the first part (A), the subject must connect with a pen in the correct order 25 numbers from 1 to 25, which are distributed randomly.
In the second part (B), the subject must connect with a pencil in the correct order an alternation of 13 numbers from 1 to 13 and 12 letters from A to L, which are also distributed randomly. The time in seconds to complete each part is measured.
Measured: baseline and 8 weeks
Change in score of Stroop test
The test includes 3 phases. In each one, participant have to give maximum of correct answer.
Score ranges from 0 to 100 for each phase
Measured: baseline and 8 weeks
Change in score of N-Back test
Number of correct answer (yes or no). Total score /23
Measured: Baseline and at 8 weeks
Change in score of attentional network test (ANT)
Test (ANT) is a computerized testing measure that analyses the three components of attention network : alerting, orienting, executive control.
Each of these three attention components is measured in time.
Measured: baseline and 8 weeks
Change in score of the number memory task
Number memory score in direct order, ranges from 0 to 16. Number memory score in indirect order, ranges from 0 to 16
Measured: baseline and 8 weeks
Change in score of the Hospital Anxiety and Depression Scale (HADS)
Anxio-depressive symptomatology based on the HADS score. The questionnaire is divided in two subscales, one for anxiety and one for depression. Each subscore ranges from 0 to 21. Scores greater than or equal to 11 on either scale indicate anxious or depressive symptomatology.
Measured: baseline and 8 weeks
Change in score of the Perceived Stress Scale (PSS)
Anxio-depressive symptomatology based on the PSS score. The total score ranges from 0 to 40. Higher scores reflect greater stress level.
Measured: baseline and 8 weeks
Change in score of the Columbia Suicide Severity Rating Scale (C-SSRS)
Evaluation of suicidality through the C-SSRS. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Measured: baseline and 8 weeks
Change in score of the World Health Organization Quality of Life (WHOQOL)
Quality of life based on the WHOQOL score. The total score ranges from 0 to 100. Higher scores reflect better health.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start30 Jan 2023
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Philippe COTTIER, Principal investigator, University hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710250
- Sponsor's protocol ID
- DR220244-MEMOREM
- Other IDs
- 2022-A02454-39
- Acronym
- MEMOREM
- Status last verified
- Nov 2023
- First submitted
- 12 Jan 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05710250
- Acronym / sponsor ID
- MEMOREM / DR220244-MEMOREM
- Conditions
- Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Study the effects of MBSR program on memory and metamemory.
- Study correlations between MBSR program effects on metamemory and scores on mental health scales (anxiety, depression, perceived stress, burnout)
- Study the correlations between MBSR program effects on memory and metamemory with those on attentional capacities, working memory, executive functions and emotion regulation
- Investigate the relationship between brain metabolites variations and the effect of the MBSR program on episodic memory and metamemory capacities, attention and emotions
- Investigate the relationship between metabolite concentrations variations and variations in volume and thickness of the cortex.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based stress reduction (MBSR) program | Experimental | Behavioral: 6-week MBSR program15 students will follow a 6-week MBSR program with 2h30 sessions per week in group and daily exercises lasting 30-40 minutes per day. |
| Muscular relaxation program | Active comparator | Behavioral: 6-week muscular relaxation program15 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Right-handed
- ≥ 18 years old
- Affiliated to a social security scheme
- Written consent signed by the participan
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-week MBSR programParticipants will follow a 6-week program of mindfulness meditation. MBSR teaches mindfulness meditation and mindful yoga exercises to develop non-judgmental awareness of moment-to-moment experience. The intervention duration is 6 weeks, with weekly two and half hours sessions. It will be delivered according to the fundamental concepts and specific techniques provided in the MBSR manualized protocol by Kabat-Zinn. The program also includes 30-min daily homework exercises. MBSR teaches four main mindfulness practices: (1) body scan, a process of moving attention through the body; (2) mindful movement, consisting of gentle yoga stretches to develop awareness of body in movement; (3) sitting meditation; and (4) walking meditation. Inquiry and didactic teaching is also a part of MBSR and allows for some detailed exploration of participants' experiences. | Behavioural | Mindfulness based stress reduction (MBSR) program |
| 6-week muscular relaxation programControl group : This group will follow a 6-week program of progressive muscle relaxation training in order to learn achieving a deep relaxation of the body through voluntary tensing and relaxing muscles. It proceeds by the individual sequentially tensing and then releasing specific groups of muscles throughout the body, and noticing how tension feels relative to relaxation. The accomplishment of physical relaxation promotes mental calmness in a parallel manner. This program is based on the work of Bernstein and Borkovec and Jacobson, and will be structured in 6-week group with weekly two and half hours sessions and out-of-session assignments for at-home practice (30-min daily). | Behavioural | Muscular relaxation program |
Primary outcome
Change from Baseline in Glumatate concentrations (mM) at 8 Weeks
Time frame: baseline and 8 weeks
Glumatate concentrations (mM) are measured by magnetic resonance spectrocopy in left hippocampal formation
14 secondary outcomes
Change in left hippocampal formation volumes (mm^3) measured on MRI 3D T1w sequence
Time frame: baseline and 8 weeks
Change in right amygdala volumes (mm^3) measured on MRI 3D T1w sequence
Time frame: baseline and 8 weeks
Change in posterior cingulate volumes (mm^3) measured on MRI 3D T1w sequence
Time frame: baseline and 8 weeks
Chang in overall brain volume measured on MRI 3D T1w sequence
Time frame: baseline and 8 weeks
Change in score the Feeling of knowing task (FOK task)
Time frame: baseline and 8 weks
Change in score of the Trail Making Test (TMT)
Time frame: baseline and 8 weeks
Change in score of Stroop test
Time frame: baseline and 8 weeks
Change in score of N-Back test
Time frame: Baseline and at 8 weeks
Change in score of attentional network test (ANT)
Time frame: baseline and 8 weeks
Change in score of the number memory task
Time frame: baseline and 8 weeks
Change in score of the Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline and 8 weeks
Change in score of the Perceived Stress Scale (PSS)
Time frame: baseline and 8 weeks
Change in score of the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: baseline and 8 weeks
Change in score of the World Health Organization Quality of Life (WHOQOL)
Time frame: baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Philippe COTTIER principal investigator
University hospital of Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-week MBSR program and 6-week muscular relaxation program in people with Behavior, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Glumatate concentrations (mM) at 8 Weeks (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.