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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02454-39 | Registry Identifier | IDRCB |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6-week MBSR program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Female
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Philippe COTTIER | University hospital of Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Center | Tours | France |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| 6-week muscular relaxation program | Behavioral | 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). |
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| 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) | 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) | 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. | 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 | baseline and 8 weeks |
| Change in score of N-Back test | Number of correct answer (yes or no). Total score /23 | 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. | 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 | 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. | 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. | 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. | 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. | baseline and 8 weeks |