NCT05710250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2023

Completed
Last Updated

February 13, 2026

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

January 12, 2023

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

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

    baseline and 8 weeks

Secondary Outcomes (14)

  • 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

  • Change in posterior cingulate volumes (mm^3) measured on MRI 3D T1w sequence

    baseline and 8 weeks

  • Chang in overall brain volume measured on MRI 3D T1w sequence

    baseline and 8 weeks

  • Change in score the Feeling of knowing task (FOK task)

    baseline and 8 weks

  • +9 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: 6-week muscular relaxation program

Interventions

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.

Mindfulness based stress reduction (MBSR) program

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).

Muscular relaxation program

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • Under legal protection or deprived of liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Investigation Center

Tours, France

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Jean Philippe COTTIER

    University hospital of Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 2, 2023

Study Start

January 30, 2023

Primary Completion

April 18, 2023

Study Completion

April 18, 2023

Last Updated

February 13, 2026

Record last verified: 2023-11

Locations