Mental Health IssueSL2i-MSCNCT06266936
Smart Life Smart Living Intercontinental - Medical Students' Cohort
An observational study of Mental Health Issue and Student Burnout, run by University Hospital, Grenoble.
Trial summary
The question of the well-being, quality of life and mental health of care students is unanimously considered to be a central issue among young adults. According to the French Ministry of Higher Education and Research, there will be 194,752 care students in France in 2021-2022. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Student Burnout
- How many people
- 1,564 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study concerns students over the age of 18 who are regularly enrolled in healthcare courses at a French university. The study involves longitudinal monitoring of the state of health of the specific population of students in care courses, from their entry into university studies (first year) until their final year of study, i.e. from 5 to 13 years depending on the course and the different universities.
Who may be able to join
- students who are regularly enrolled in healthcare courses at a French university
Who cannot join
- Age under 18
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Aida Manzo contact
About this study
The question of the well-being, quality of life and mental health of care students is unanimously considered to be a central issue among young adults. According to the French Ministry of Higher Education and Research, there will be 194,752 care students in France in 2021-2022. The quality of life and well-being of health students can be affected at several levels. The first is mental health. In France, the mental health of these students has deteriorated considerably in recent years. According to a 2017 survey of 21,768 French medical students, 66% of them had an anxiety disorder and 27% a depressive syndrome. In addition, a number of risk factors have been identified for the mental health of health students.
The aim of the study is to carry out a longitudinal evaluation of the mental health status of care students during their university studies in France through anxiety, depression and perceived stress.
- Conditions
- Mental Health Issue, Student Burnout
- Being tested
- No intervention
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
The study involves longitudinal monitoring of the state of health of the specific population of students in care courses, from their entry into university studies (first year) until their final year of study, i.e. from 5 to 13 years depending on the course and the different universities.
| Study group | Role | What they receive |
|---|---|---|
| Cohort with health students | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synthetic score on standardized assessment scale of anxiety
State Trait Anxiety Inventory (STAI)
Measured: 1 hour
Secondary outcomes (2)
Synthetic score on standardized assessment scale of mental health
Hospital Anxiety Depression (HAD)
Measured: 1 hour
Synthetic score on standardized assessment scale of stress
Scale and Perceived Stress Scale (PSS-14)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2044 (estimated)
- Study completionDec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Nicolas Vuillerme, PhD, Study chair, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266936
- Sponsor's protocol ID
- EssaiClinique_SL2i-MSC
- Acronym
- SL2i-MSC
- Status last verified
- Apr 2024
- First submitted
- 22 Dec 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Life Smart Living Intercontinental - Medical Students' Cohort
- ClinicalTrials.gov ID
- NCT06266936
- Acronym / sponsor ID
- SL2i-MSC / EssaiClinique_SL2i-MSC
- Conditions
- Mental Health Issue, Student Burnout
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,564 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2044 (estimated)
- Study completion
- Dec 2044 (estimated)
- First posted
- 20 Feb 2024 (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.
The question of the well-being, quality of life and mental health of care students is unanimously considered to be a central issue among young adults. According to the French Ministry of Higher Education and Research, there will be 194,752 care students in France in 2021-2022. The quality of life and well-being of health students can be affected at several levels. The first is mental health. In France, the mental health of these students has deteriorated considerably in recent years. According to a 2017 survey of 21,768 French medical students, 66% of them had an anxiety disorder and 27% a depressive syndrome. In addition, a number of risk factors have been identified for the mental health of health students.
The aim of the study is to carry out a longitudinal evaluation of the mental health status of care students during their university studies in France through anxiety, depression and perceived stress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort with health students | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study concerns students over the age of 18 who are regularly enrolled in healthcare courses at a French university. The study involves longitudinal monitoring of the state of health of the specific population of students in care courses, from their entry into university studies (first year) until their final year of study, i.e. from 5 to 13 years depending on the course and the different universities.
Key inclusion criteria (1 listed)
- students who are regularly enrolled in healthcare courses at a French university
Key exclusion criteria (1 listed)
- Age under 18
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 |
|---|---|---|
| No interventionThe study involves longitudinal monitoring of the state of health of the specific population of students in care courses, from their entry into university studies (first year) until their final year of study, i.e. from 5 to 13 years depending on the course and the different universities. | Other | Cohort with health students |
Primary outcome
Synthetic score on standardized assessment scale of anxiety
Time frame: 1 hour
State Trait Anxiety Inventory (STAI)
2 secondary outcomes
Synthetic score on standardized assessment scale of mental health
Time frame: 1 hour
Synthetic score on standardized assessment scale of stress
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Aida Manzo contact
Nicolas Vuillerme, PhD study chair
University Grenoble Alps
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue and Student Burnout, run by University Hospital, Grenoble.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Bellier, MD PhD (+33476767575, abellier@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Synthetic score on standardized assessment scale of anxiety (time frame: 1 hour). 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 17 Apr 2024.