Precarity and Reduction of Its Impact on the Mental Health of Health Students (PRISMES)

April 13, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Student financial insecurity has become a major public health and societal issue affecting a growing proportion of young adults in higher education, exacerbated by the COVID-19 pandemic and more recently by inflation. Health students may be particularly exposed because of the demanding and lengthy nature of their training, often combined with limited opportunities for paid work due to hospital placements and academic workload. A national study conducted in 2024 by our team at Institut national de la santé et de la recherche médicale U1073 under the supervision of the Conférence Nationale des Doyens de Médecine among more than 12,000 health students showed that 12% experienced severe financial insecurity, characterized by insufficient monthly resources, recurrent bank overdrafts, and frequent food deprivation, while 20% reported moderate insecurity. Financial insecurity was strongly associated with anxiety, depression, and emotional exhaustion, while vulnerable students were also more likely to forgo healthcare, including psychological consultations, for financial reasons. This vicious circle between financial hardship and mental health may compromise academic success and justifies targeted intervention.

Although support systems such as Santé Psy Étudiant and free psychological consultations at the faculty already exist, they remain underused because of stigma, insufficient information, or perceived barriers to access. The PRISMES project proposes a participatory, adaptive, and real-world intervention designed to improve mental health support for financially vulnerable health students.

Students directly participate in the co-construction of interventions together with researchers, student associations, health professionals, academic representatives, and a sociologist involved in understanding social determinants, mental health representations, and barriers to participation. Three intervention formats will initially be proposed, Three types of interventions are offered to students. Intervention I consists of four individual psychological consultations. Intervention II includes two collective workshops focused on stress and budget management, combined with two sophrology sessions. Intervention III comprises one psychological consultation and two collective workshops on stress and budget management.. This non-randomized design reflects real-life implementation conditions and improves future transferability.

The main objective is to provide concrete support to financially vulnerable students by improving well-being, mental health, and knowledge of available support systems. Secondary objectives are to evaluate intervention effects on anxiety, depression, stress, quality of life, and emotional exhaustion, to adapt interventions according to feedback, and to improve awareness and use of social and health support services.

A mixed-method design will combine quantitative and qualitative data. Quantitative assessments will be conducted monthly during the three months following the first intervention and again three months after the final intervention. Validated questionnaires will assess perceived stress (Cohen scale), anxiety and depression (HAD score), quality of life, and emotional exhaustion (MBI-SS). Qualitative interviews and focus groups conducted at the end of the intervention will explore perceived benefits, barriers, and implementation factors among students and professionals.

The adaptive design allows continuous adjustment according to interim findings. For example, if attendance is limited by timetable constraints, sessions may be rescheduled. Feedback loops involving participants and stakeholders will guide iterative improvement.

Eligible participants are health students aged 18-30 enrolled at Université de Rouen Normandie presenting at least one indicator of financial insecurity: insufficient monthly resources, recurrent overdraft, or frequent food deprivation. Students currently receiving psychological follow-up are excluded.

Assuming a reduction in anxiety prevalence from 55% to 45%, 88 participants are required; with 20% loss to follow-up, 110 students will be included. Among approximately 4,500 health students in Rouen, about 540 are estimated to experience severe insecurity and 900 moderate insecurity, ensuring strong feasibility. PRISMES aims to generate directly transferable recommendations for university support policies and improve resilience, well-being, and academic success.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Population The study population consists of financially vulnerable health students aged 18 to 30 years enrolled at Université de Rouen Normandie, across all health programs. This population was selected due to its particular vulnerability, especially regarding mental health and the risk of academic failure, as highlighted in previous studies, including the national survey on the living conditions of health students (CoViES). No specific program was targeted because all health disciplines include a significant number of financially vulnerable students.

Inclusion Criteria

Participants must meet all of the following criteria:

Enrollment as a health student at the Faculty of Health, Université de Rouen Normandie (any program or discipline).

Age between 18 and 30 years.

Meet at least one of the following three financial vulnerability criteria:

Insufficient monthly funds to cover basic living expenses. Recurrent monthly bank overdraft. Frequent omission of food purchases due to financial constraints. Affiliation with a social security scheme or beneficiary of such a scheme. Exclusion Criteria

Participants meeting any of the following criteria will be excluded:

Currently receiving, or having received in the past 12 months, psychological or sophrology follow-up.

Currently treated for, or having been treated in the past 12 months for, anxiety or depression

Study Visits and Follow-up Each participant will be involved in the study for a total of six months, including an inclusion visit (M0), a three-month intervention phase (M0-M3), and a three-month post-intervention follow-up phase (M3-M6).

Inclusion Visit (M0) Location: Faculty of Health, Université de Rouen Normandie, conducted by a physician or other qualified personnel (psychologist, sophrologist).

Objectives:

Confirm eligibility according to inclusion and exclusion criteria. Provide detailed information about the study and obtain electronic informed consent.

Collect baseline sociodemographic, health, and mental health data using online self-administered questionnaires, including the Hospital Anxiety and Depression scale (HAD), the Maslach Burnout Inventory - Student Survey (MBI-SS), the Satisfaction with Life Scale (SWLS), and knowledge of available support services.

Assign participants to one of the three intervention modalities according to their preference.

Estimated duration: 1 hour End-of-Intervention Assessment (M3) Location: Online questionnaire and/or on-site interview for participants selected for the qualitative component.

Objectives:

Assess mental health and quality of life indicators at the end of the intervention (HAD, MBI-SS, SWLS).

Evaluate participants' knowledge and use of support services. Measure overall satisfaction using a 5-point Likert scale. Online questionnaire duration: 20-30 minutes Qualitative Data Collection (Visit 1 bis) Method: Focus groups conducted with a subsample of 20 students. Objectives: Explore perceived benefits, barriers, and implementation factors of the interventions.

Estimated duration: 1 hour 30 minutes Post-Intervention Follow-up (M6) Location: Online follow-up questionnaire.

Objectives:

Evaluate the sustainability of intervention effects on mental health (HAD, MBI-SS), quality of life (SWLS), and continued use of support services.

Identify potential needs for extended or additional support. Estimated duration: 20-30 minutes

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Enrollment as a health student at the Faculty of Health, Université de Rouen Normandie (any program or discipline).

Age between 18 and 30 years.

Meet at least one of the following three financial vulnerability criteria:

Insufficient monthly funds to cover basic living expenses. Recurrent monthly bank overdraft. Frequent omission of food purchases due to financial constraints. Affiliation with a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

  • Participants meeting any of the following criteria will be excluded:

Currently receiving, or having received in the past 12 months, psychological or sophrology follow-up.

Currently treated for, or having been treated in the past 12 months for, anxiety or depression.

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

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: four individual psychological consultations.
Behavioral: Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student
The PRISMES intervention is a participatory, adaptive program for financially vulnerable health students aged 18-30. It involves students in co-constructing the intervention, including selecting session types (psychological consultations, sophrology, workshops) and topics. Participants choose among three flexible modalities combining individual support, group workshops on stress and budget management, and sophrology sessions. The program integrates existing university resources (e.g., Santé Psy Étudiant) and adapts continuously based on participant feedback, ensuring real-world feasibility. A mixed-methods evaluation, using quantitative measures (HAD, MBI-SS, SWLS) and qualitative focus groups, provides a comprehensive understanding of mental health outcomes and barriers, making PRISMES distinct from conventional student mental health programs.
Experimental: two collective workshops focused on stress and budget management, combined with two sophrology sessi
Behavioral: Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student
The PRISMES intervention is a participatory, adaptive program for financially vulnerable health students aged 18-30. It involves students in co-constructing the intervention, including selecting session types (psychological consultations, sophrology, workshops) and topics. Participants choose among three flexible modalities combining individual support, group workshops on stress and budget management, and sophrology sessions. The program integrates existing university resources (e.g., Santé Psy Étudiant) and adapts continuously based on participant feedback, ensuring real-world feasibility. A mixed-methods evaluation, using quantitative measures (HAD, MBI-SS, SWLS) and qualitative focus groups, provides a comprehensive understanding of mental health outcomes and barriers, making PRISMES distinct from conventional student mental health programs.
Experimental: one psychological consultation and two collective workshops on stress and budget management
Behavioral: Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student
The PRISMES intervention is a participatory, adaptive program for financially vulnerable health students aged 18-30. It involves students in co-constructing the intervention, including selecting session types (psychological consultations, sophrology, workshops) and topics. Participants choose among three flexible modalities combining individual support, group workshops on stress and budget management, and sophrology sessions. The program integrates existing university resources (e.g., Santé Psy Étudiant) and adapts continuously based on participant feedback, ensuring real-world feasibility. A mixed-methods evaluation, using quantitative measures (HAD, MBI-SS, SWLS) and qualitative focus groups, provides a comprehensive understanding of mental health outcomes and barriers, making PRISMES distinct from conventional student mental health programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participation rate in the offered sessions is defined as the ratio between the total number of sessions
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

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 (Estimated)

September 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C25-114
  • 2026-A00774-47 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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