NCT07539207

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

university studenteconomic precaritymental health

Outcome Measures

Primary Outcomes (1)

  • Participation rate in the offered sessions is defined as the ratio between the total number of sessions

    3 months

Study Arms (3)

four individual psychological consultations.

EXPERIMENTAL
Behavioral: Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student

two collective workshops focused on stress and budget management, combined with two sophrology sessi

EXPERIMENTAL
Behavioral: Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student

one psychological consultation and two collective workshops on stress and budget management

EXPERIMENTAL
Behavioral: Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student

Interventions

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.

four individual psychological consultations.one psychological consultation and two collective workshops on stress and budget managementtwo collective workshops focused on stress and budget management, combined with two sophrology sessi

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health, Université de Rouen Normandie

Rouen, France

Location

Related Publications (3)

  • Wathelet M, Duhem S, Vaiva G, Baubet T, Habran E, Veerapa E, Debien C, Molenda S, Horn M, Grandgenevre P, Notredame CE, D'Hondt F. Factors Associated With Mental Health Disorders Among University Students in France Confined During the COVID-19 Pandemic. JAMA Netw Open. 2020 Oct 1;3(10):e2025591. doi: 10.1001/jamanetworkopen.2020.25591.

    PMID: 33095252BACKGROUND
  • Baggio S, Iglesias K, Fernex A. Healthcare renunciation among young adults in French higher education: A population-based study. Prev Med. 2017 Jun;99:37-42. doi: 10.1016/j.ypmed.2017.02.002. Epub 2017 Feb 8.

    PMID: 28189805BACKGROUND
  • Pisaniello MS, Asahina AT, Bacchi S, Wagner M, Perry SW, Wong ML, Licinio J. Effect of medical student debt on mental health, academic performance and specialty choice: a systematic review. BMJ Open. 2019 Jul 2;9(7):e029980. doi: 10.1136/bmjopen-2019-029980.

    PMID: 31270123BACKGROUND

MeSH Terms

Conditions

Psychological Well-BeingDepression

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations