Cohort Study on Medical Students' Mental Health

NCT ID: NCT07305701

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-22
• Study Completion Date: 2047-10-31

Brief Summary

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.

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.

Conditions

Major Depressive Disorder; Generalized Anxiety Disorder; Suicidal Ideation; Alcoholism; Marijuana Abuse; Loneliness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Medical students

Medical students: students who succeed to integrate medical school after the selection at the end of the first year of health studies.

Questionnaire

Intervention Type: OTHER

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.

Questionnaire

Intervention Type: OTHER

Questionnaire to be completed once a year

Interventions

Questionnaire

Questionnaire to be completed once a year

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jasmina MALLET, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHOrléans

Locations

Centre Hospitalier Universitaire d'Orléans

Orléans, Loiret, France

Site Status: RECRUITING

Countries

France

Central Contacts

Jasmina MALLET, MD-PhD

Role: CONTACT

jasmina.mallet@chu-orleans.fr

0238229795 ext. +33

Fanny LOUAT

Role: CONTACT

fanny.louat@chu-orleans.fr

0238744295 ext. +33

Facility Contacts

Jasmina MALLET, MD-PhD

Role: primary

jasmina.mallet@chu-orleans.fr

0238229795

References

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Other Identifiers

CHUO-2025-10

Identifier Type: -

Identifier Source: org_study_id