Cohort Study on Medical Students' Mental Health (OSMOSE)

December 26, 2025 updated by: Centre Hospitalier Régional d'Orléans

Mental Health of Medical Students in Orleans: a Cohort Study of a New Faculty

The main objective of this study is to identify risk factors for depression among medical students by comparing them to students who completed their first year but did not enter the medical program (students not accepted into the second year of medical school).

Major Depressive Disorder (MDD) will be assessed using a validated tool: the Composite International Diagnostic Interview Short-Form (CIDI-SF).

This a prospective, longitudinal, cohort study. The plan is to inform each new cohort of students at the Orléans University Hospital medical school for 10 years. It is estimated that 5,000 to 10,000 students will be able to participate in the study.

A link to access the study questionnaire will be sent to students by email via the registrar's office, with one email per week for four weeks. The email will contain a link to a web page where the questionnaire can be completed. The questionnaire will be available online on computers or smartphones for six weeks: from mid-October to the end of November. The questionnaire will be completed each year for the duration of the study or until the student completes their studies.

Duration of the inclusion period: 10 years Duration of participation for each participant: maximum 12 years Total duration of the study: 22 years As the cohort progresses, longitudinal analyses may be conducted to study the evolution of various disorders over time, adjusting for known confounding factors. Following the initial analyses of this study, a new interventional study will be set up to identify students at risk and offer them appropriate care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The COVID-19 pandemic has led to an increase in depression, particularly among younger people. The French Health Barometer, conducted every 4-5 years by Santé Publique France (SPF), found that the prevalence of a major depressive disorder (MDD) among 18-25 years old doubled (from 11.7% to 20.8%) between 2017 and 2021. There has also been an increase in suicidal thoughts and suicide attempts. Among students, data from the 2016 of observatoire de la vie étudiante (OVE) showed a higher prevalence of MDD and suicidal thoughts among students compared to the general population of the same age group. For medical students, a national study conducted in 2021 revealed rates of depression and suicidal thoughts far exceeding those of the general population of the same age. Financial difficulties were the main factor associated with the risk of depression. Indeed, students are a particularly vulnerable population to precariousness due to several factors. Economically, they often have limited income, relying on parental support, insufficient scholarships, or precarious jobs. This exposes them to difficulties in meeting essential needs such as housing, food, and healthcare. Socially, isolation can worsen their situation, especially when they move away from their family network or faced with academic pressure. Furthermore, high academic demands combined with unstable living conditions affect their mental health and may contribute to the development of psychiatric disorders, often untreated due to lack of resources or accessible care. This multidimensional precariousness highlights the need for comprehensive support for this population, especially since students rarely seek professional help. In the 2021 survey, only 32% of medical students suffering from depression received adequate care. To improve the health of medical students, it is therefore not enough to treat disorders; we must also prevent their onset by helping students achieve a state of well-being.

This a prospective, longitudinal, cohort study aims is to identify risk factors for depression among medical students by comparing them to students who completed their first year but did not enter in the medical program (students not accepted into the second year of medical school). The main objective of this study is to assess Major Depressive Disorder (MDD) using a validated tool : the Composite International Diagnostic Interview Short-Form (CIDI-SF).

We will assess the 12-month prevalence of the main psychiatric disorders evaluated, dropout using a single question, and loneliness. Care utilization will be measured, as well as care avoidance and its causes, along with financial and social insecurity, educational satisfaction, and stigma. Additional variables or questionnaires may be added through protocol amendments. These measurements will be obtained through students filling out an online questionnaire. Quantitative analyses will be conducted, starting with univariate and then multivariate models, with adjustments for known confounding factors.

The plan is to inform each cohort of students at the Orléans University Hospital medical school for 10 years. It is estimated that 5,000 to 10,000 students will be able to participate in the study.

Each year, all medical students will be informed of the protocol at meetings at the University of Orléans at the start of the academic year in September regardless of their year of study (e.g. 1st year of medical study, 2nd, 3rd, 4th year of study etc…). The study will be offered each year to students entering PASS/LAS at the Faculty of Medicine of the University of Orléans and to cohorts that have already begun their medical studies.

A link to access the study questionnaire will be sent to students by email via the registrar's office, with one email per week for four weeks. The email will contain a link to a Callyope platform where the questionnaire can be completed. Students will create an account using their university email address as their username. If the student does not object, they will have to answer the first question of the questionnaire and then complete the full online questionnaire on the Callyope platform. The questionnaire will be available online on computers or smartphones for six weeks: from mid-October to the end of November. The questionnaire will be completed each year between mid-October and the end of November for the duration of the study or until the student completes their studies.

Duration of the inclusion period: 10 years Duration of participation for each participant: maximum 12 years Total duration of the study: 22 years

As the cohort progresses, longitudinal analyses may be conducted to study the evolution of various disorders over time, adjusting for known confounding factors. Following the initial analyses of this study, a new interventional study will be set up to identify students at risk and offer them appropriate care.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Loiret
      • Orléans, Loiret, France, 45067
        • Recruiting
        • Centre Hospitalier Universitaire d'Orléans
        • Contact:
        • Principal Investigator:
          • Jasmina MALLET, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All students who were enrolled in their first year of health studies at the University of Orléans

Description

Inclusion Criteria:

  • Students who have been enrolled in first year of health studies at the University of Orléans
  • Aged 18 or over

Exclusion Criteria:

  • Does not speak French
  • Person under legal guardianship
  • Person deprived of liberty
  • Person under guardianship or trusteeship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medical students
Medical students: students who succeed to integrate medical school after the selection at the end of the first year of health studies.
Other: Questionnaire
Questionnaire to be completed once a year
Non medical students
Non medical students: students who fail to integrate medical school after the selection at the end of the first year of health studies.
Other: Questionnaire
Questionnaire to be completed once a year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure Major Depressive Disorder prevalence
Time Frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Measure of the 12-month Major Depressive Disorder prevalence by the Composite International Diagnostic Interview Short-Form (CIDI-SF).
Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure prevalence of psychiatric disorders
Time Frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

Measure the annual prevalence of psychiatric disorders other than depression (anxiety, burnout, eating disorders, alcohol and cannabis addiction, childhood trauma) among medical students by comparing them to students who completed their first year but did not enter the medical.

Anxiety will be assessed using the GAD7; eating disorders by the SCOFF, alcohol addiction by the AUDIT, cannabis addiction by the CUDIT, burnout by the MBI-SS (student version for pre-clinical students) or the MBI-HSS (caregiver version for externs and residents), and childhood trauma by the ACE.
Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Identify risk and protective factors for psychiatric disorders
Time Frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

Identify risk and protective factors for psychiatric disorders other than depression (anxiety, burnout, eating disorders, alcohol and cannabis addiction) among medical students by comparing them to students who completed their first year but did not enter the medical program.

Anxiety will be assessed using the GAD7; eating disorders by the SCOFF, alcohol addiction by the AUDIT, cannabis addiction by the CUDIT, burnout by the MBI-SS (student version for pre-clinical students) or the MBI-HSS (caregiver version for externs and residents), and childhood trauma by the ACE.
Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Measure Major Depressive Disorder prevalence by year
Time Frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Measure the prevalence of major depressive disorder each year among medical students by comparing them to students who have completed their first year but have not entered the medical program. Major Depressive Disorder prevalence will be measure by the Composite International Diagnostic Interview Short-Form (CIDI-SF).
Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Measure the prevalence of healthcare use and non-use
Time Frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Measure the prevalence of healthcare use and non-use among medical students each year by comparing them to students who completed their first year but did not enter the medical program. Healthcare use will be assessed using questions from the WHO quality of life questionnaire, the Observatoire de la Vie Etudiants questionnaires, and the Mental Ill-ness : Clinicians' Attitudes (MICA).
Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Identify risk factors for non-use of healthcare
Time Frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Identify risk factors for non-use of healthcare among medical students by comparing them to students who completed their first year but did not enter the medical program. Healthcare use will be assessed using questions from the WHO quality of life questionnaire, the Observatoire de la Vie Etudiants questionnaires, and the Mental Ill-ness : Clinicians' Attitudes (MICA).
Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Assess the stigma associated with psychiatric disorders
Time Frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

Assess the stigma associated with psychiatric disorders or the discipline of psychiatry among medical students by comparing them to students who completed their first year but did not enter the medical program. Stigma will be assessed using questions from the WHO quality of life questionnaire, the Observatoire de la Vie Etudiants questionnaires, and the Mental Ill-ness : Clinicians' Attitudes (MICA).

Assessment of childhood trauma using the Adverse Childhood Experiences scale.
Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Factors of financial and social insecurity
Time Frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Study the factors of financial and social insecurity (several variables) among medical students by comparing them to students who completed their first year but did not enter the medical program. Financial and social insecurity will be assessed using questions from the WHO quality of life questionnaire, the Observatoire de la Vie Etudiants questionnaires, and the Mental Ill-ness : Clinicians' Attitudes (MICA). Loneliness will be assessed using the UCLA loneliness
Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
Assessment of educational support
Time Frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.
For postgraduate students, assess their feelings about educational support.
Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Jasmina MALLET, MD-PhD, CHOrléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2025

Primary Completion (Estimated)

October 31, 2047

Study Completion (Estimated)

October 31, 2047

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Estimated)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUO-2025-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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