- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07618208
Student Precarity and Psychiatry (PEPSY)
Impact of Precarity on the Emergence of Psychiatric Disorders and the Use of Care Among Students
Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021. This phenomenon particularly affects students, who are already identified as being at greater risk of mental health disorders than the general population. Medical students seem to be particularly vulnerable: in 2021, a national study showed very high rates of depression and suicidal thoughts in this population. The main factor associated with depression was the feeling of financial hardship.
Students often face multiple forms of insecurity. Financially, they have limited resources and struggle to cover their basic needs such as housing, food and healthcare. Socially, many experience significant isolation, particularly when they are away from their families or under pressure from their studies. All of this has a significant impact on their mental health. Unfortunately, many students do not seek help due to lack of time, resources, or awareness of support services. The 2021 study showed that only one-third of medical students suffering from depression received appropriate treatment.
The aim of our study is to assess the impact of precariousness on the onset of psychiatric disorders and on the use or non-use of healthcare services.
Our study will involve nearly 45,000 students from PSL and UPC universities. It is based on a longitudinal cohort (via questionnaires) over three years. The aim is to identify precisely the different aspects of student precariousness (housing, transport, isolation, economic difficulties, etc.) and their link with psychological distress. The study will measure the extent of the phenomenon and identify modifiable factors that could be targeted by preventive measures. The results will enable us to better target preventive measures and propose concrete solutions to improve students' well-being and promote their success.
Study Overview
Status
Intervention / Treatment
Detailed Description
The COVID-19 pandemic has led to an increase in depression, particularly among young people. The French health barometer, conducted every 4-5 years by Santé Publique France (SPF), found that the prevalence of major depressive episodes (MDE) among 18-25 year olds 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 Student Life Observatory (OVE) found a higher prevalence of CDE and suicidal thoughts among students than in the general population of the same age. Among the factors associated with the risk of EDC, experiencing significant financial difficulties was the main one[4]. Among medical students, a national study conducted in 2021 found that the prevalence of depression and suicidal thoughts was much higher than in the general population of the same age. Financial difficulties were also the main factor associated with the risk of depression. Indeed, students are a population that is particularly vulnerable to precariousness due to several factors. Economically, they often have limited incomes, depending on parental support, insufficient grants or precarious jobs. This exposes them to difficulties in meeting their basic needs such as housing, food and healthcare. Socially, isolation can exacerbate their situation, especially when they are far from their family network or under pressure from their studies. In addition, high academic demands, combined with unstable living conditions, impact their mental health and can contribute to the development of psychiatric disorders, which often go untreated due to a lack of affordable and accessible resources. International students are even more vulnerable due to language and administrative barriers and limited access to local support services. This multidimensional precariousness highlights the need for comprehensive support for this population, even though students are unlikely to seek professional help. In the 2021 survey, only 32% of medical students suffering from depression received adequate care. If we want to improve the health of medical students, we must not only treat disorders, but also prevent them from occurring by helping students strive for a state of well-being. In terms of prevention, the Haute Autorité de Santé (HAS) distinguishes between three levels: primary prevention, which acts upstream of the disease (on risk factors); secondary prevention, which acts at an early stage of its development (screening); and tertiary prevention, which acts on complications and the risk of recurrence.
The objectives of the study are to identify and quantify the modifiable predictive and moderating factors explaining students' psychological distress that could give rise to (primary) prevention actions by studying the various components of precariousness (housing, transport, study conditions, social isolation, grants, etc.). It also aims to study the impact of the various components of precariousness on the use and non-use of healthcare (screening and treatment, secondary and tertiary prevention).
The data will be entered directly by participants on the SKEZIA platform (https://skezi.eu/) (a solution developed by SKEZI) co-founded by AP-HP and Paris-Cité University, and will be hosted on HDS-approved servers.
Main objective:
The objective is to explore the impact of precariousness on the risk of characterised depressive episodes and the use of healthcare among PSL students (17,000 students) and UPC health faculty students (28,000 students).
Primary outcome measure:
The study will assess the 12-month prevalence of:
- characterised depressive episodes (using the Composite International Diagnostic Interview Short-Form (CIDI-SF)) and suicidal ideation in the same way as SPF and OVE;
- use of healthcare services, which will be measured in a similar way to the OVE survey and the medical student survey.
Precariousness will be assessed by the question: 'Would you say that you are currently experiencing financial difficulties?'
Secondary objectives and evaluation criteria:
The secondary objectives are to :
- evaluate the prevalence of :
- anxiety, which will be assessed using the GAD7;
- eating disorders, which will be assessed using the SCOFF;
- alcohol addiction, which will be assessed using the AUDIT, and cannabis addiction, which will be assessed using the CAST;
- burnout, using the student version, which will be assessed using the MBI-SS for pre-clinical or healthcare students and the MBI-HSS for externs and residents,
- dropout, which will be assessed by a single question as in the CNA-CORE survey,
- insomnia, which will be measured by the Insomnia Severity Index (ISI),
- loneliness, which will be assessed using the UCLA 3 items,
- harassment,
- discriminatory treatment,
- and quality of life (WHOQOL);
- identify and quantify modifiable predictive and moderating factors explaining students' psychological distress that could lead to (primary) prevention measures = by studying the various components of precariousness (housing, transport, study conditions, social isolation, grants, etc.),
- study the impact of the various components of precariousness on the use and non-use of healthcare (screening and treatment, secondary and tertiary prevention). This will be assessed using questions on the renunciation of healthcare and its causes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie Benhammani-Godard
- Phone Number: 0033158411190
- Email: marie.godard@aphp.fr
Study Contact Backup
- Name: Cédric LEMOGNE, PR
- Phone Number: 00331 42 34 85 76
- Email: cedric.lemogne@aphp.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Student enrolled at Paris Sciences et Lettres University (PSL, 17,000 students) or the Faculty of Health Sciences at Paris Cité University (UPC, 28,000 students),
- Aged 18 or over,
- Fluent in French,
- Affiliated to a health insurance.
Exclusion Criteria:
- Applicants under the age of 18,
- Not enrolled at PSL universities or the UPCS Faculty of Health,
- Insufficient level of French.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Health students
All students enrolled at the Faculty of Health Sciences of Paris Cité University
|
Questionnaires
|
|
Non-health students
All students enrolled at Paris Sciences and Letters University
|
Questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite International Diagnostic Interview Short-Form (CIDI-SF)
Time Frame: Day 0
|
12-months prevalence Major Depressive Disorder and suicidal thoughts Composite International Diagnostic Interview Short-Form (CIDI-SF)
|
Day 0
|
|
Composite International Diagnostic Interview Short-Form (CIDI-SF)
Time Frame: 12 months
|
12-months prevalence Major Depressive Disorder and suicidal thoughts Composite International Diagnostic Interview Short-Form (CIDI-SF)
|
12 months
|
|
Use of care
Time Frame: Day 0
|
Use of care service of care professional
|
Day 0
|
|
Use of care
Time Frame: 12 months
|
Use of care service of care professional
|
12 months
|
|
Precarity
Time Frame: Day 0
|
Question "Would you say that you are currently experiencing financial difficulties?"
|
Day 0
|
|
Precarity
Time Frame: 12 months
|
Question "Would you say that you are currently experiencing financial difficulties?"
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GAD7
Time Frame: Day 0
|
Prevalence of anxiety
|
Day 0
|
|
GAD7
Time Frame: 12 months
|
Prevalence of anxiety
|
12 months
|
|
GAD7
Time Frame: 24 months
|
Prevalence of anxiety
|
24 months
|
|
SCOFF
Time Frame: Day 0
|
Prevalence of Eating disorders
|
Day 0
|
|
SCOFF
Time Frame: 12 months
|
Prevalence of Eating disorders
|
12 months
|
|
SCOFF
Time Frame: 24 months
|
Prevalence of Eating disorders
|
24 months
|
|
AUDIT
Time Frame: Day 0
|
Prevalence of Alcohol addiction
|
Day 0
|
|
AUDIT
Time Frame: 12 months
|
Prevalence of Alcohol addiction
|
12 months
|
|
AUDIT
Time Frame: 24 months
|
Prevalence of Alcohol addiction
|
24 months
|
|
CAST
Time Frame: Day 0
|
Prevalence of cannabis addiction
|
Day 0
|
|
CAST
Time Frame: 12 months
|
Prevalence of cannabis addiction
|
12 months
|
|
CAST
Time Frame: 24 months
|
Prevalence of cannabis addiction
|
24 months
|
|
MBI-SS or MBI-HSS
Time Frame: Day 0
|
Prevalence of Burnout using the student version : will be assessed using the MBI-SS for pre-clinical students or caregivers or Prevalence of Burnout using the student version : will be assessed using the MBI-HSS for externs and residents
|
Day 0
|
|
MBI-SS or MBI-HSS
Time Frame: 12 months
|
Prevalence of Burnout using the student version : will be assessed using the MBI-SS for pre-clinical students or caregivers or Prevalence of Burnout using the student version : will be assessed using the MBI-HSS for externs and residents Time Frame: D0
|
12 months
|
|
MBI-SS or MBI-HSS
Time Frame: 24 months
|
Prevalence of Burnout using the student version : will be assessed using the MBI-SS for pre-clinical students or caregivers or Prevalence of Burnout using the student version : will be assessed using the MBI-HSS for externs and residents Time Frame: D0
|
24 months
|
|
A single question as in the CNA-CORE survey
Time Frame: Day 0
|
Prevalence of Dropout: will be assessed using a single question as in the CNA-CORE survey
|
Day 0
|
|
A single question as in the CNA-CORE survey
Time Frame: 12 months
|
Prevalence of Dropout: will be assessed using a single question as in the CNA-CORE survey
|
12 months
|
|
A single question as in the CNA-CORE survey
Time Frame: 24 months
|
Prevalence of Dropout: will be assessed using a single question as in the CNA-CORE survey
|
24 months
|
|
Insomnia Severity Index (ISI)
Time Frame: Day 0
|
Prevalence of Insomnia
|
Day 0
|
|
Insomnia Severity Index (ISI)
Time Frame: 12 months
|
Prevalence of Insomnia
|
12 months
|
|
Insomnia Severity Index (ISI)
Time Frame: 24 months
|
Prevalence of Insomnia
|
24 months
|
|
UCLA 3 items
Time Frame: Day 0
|
Prevalence of Loneliness
|
Day 0
|
|
UCLA 3 items
Time Frame: 12 months
|
Prevalence of Loneliness
|
12 months
|
|
UCLA 3 items
Time Frame: 24 months
|
Prevalence of Loneliness
|
24 months
|
|
Questions about harrassment
Time Frame: Day 0
|
Harrassment
|
Day 0
|
|
Questions about harrassment
Time Frame: 12 months
|
Harrassment
|
12 months
|
|
Questions about harrassment
Time Frame: 24 months
|
Harrassment
|
24 months
|
|
Questions about discriminatory treatment
Time Frame: Day 0
|
Discriminatory treatment
|
Day 0
|
|
Questions about discriminatory treatment
Time Frame: 12 months
|
Discriminatory treatment
|
12 months
|
|
Questions about discriminatory treatment
Time Frame: 24 months
|
Discriminatory treatment
|
24 months
|
|
WHOQOL
Time Frame: Day 0
|
Quality of life
|
Day 0
|
|
WHOQOL
Time Frame: 12 months
|
Quality of life
|
12 months
|
|
WHOQOL
Time Frame: 24 months
|
Quality of life
|
24 months
|
|
Components of precariousness
Time Frame: Day 0
|
Predictive and moderating factors = by studying the different components of precariousness (housing, transport, study conditions, social isolation, grants, etc.).
|
Day 0
|
|
Components of precariousness
Time Frame: 12 months
|
Predictive and moderating factors = by studying the different components of precariousness (housing, transport, study conditions, social isolation, grants, etc.).
|
12 months
|
|
Questions on the renunciation of healthcare and its causes.
Time Frame: 12 months
|
Impact of the various components of precariousness on the use and non-use of healthcare will be assessed using questions on the renunciation of healthcare and its causes.
|
12 months
|
|
Components of precariousness
Time Frame: 24 months
|
Predictive and moderating factors = by studying the different components of precariousness (housing, transport, study conditions, social isolation, grants, etc.).
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Behavioral Symptoms
- Self-Injurious Behavior
- Mood Disorders
- Suicide
- Anxiety Disorders
- Depressive Disorder
- Behavior
- Suicidal Ideation
- Depression
- Depressive Disorder, Major
- Generalized Anxiety Disorder
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- APHP251300
- N°IDRCB : 2025-A01968-41 (Other Identifier: France : Ministry of Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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