Mental Health (Depression)PRISMESNCT07539207
Precarity and Reduction of Its Impact on the Mental Health of Health Students
A study testing Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student in people with Mental Health (Depression) and Mental Health, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health (Depression), Mental Health, Quality of Lifte
- What is being tested?
- Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Faculty of Health, Université de Rouen Normandie
Rouen
Tavolacci, +332888839, mp.tavolacci@chu-rouen.fr
About this study
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 the Unit 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.
Read more
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.
Read the detailed description
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.
Choice of the 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
- Conditions
- Mental Health (Depression), Mental Health, Quality of Lifte
- Being tested
- Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student
- Keywords
- university student, economic precarity, mental health
- Medical subject headings
- Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Mental Health and Well-being Support for Financially Vulnerable Health StudentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| four individual psychological consultations. | Experimental | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: Behavioral: Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate in the offered sessions is defined as the ratio between the total number of sessions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental Health (Depression)Studies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539207
- Sponsor's protocol ID
- C25-114
- Other IDs
- 2026-A00774-47
- Acronym
- PRISMES
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33095252Baggio 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.
PubMed 28189805Pisaniello 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.
PubMed 31270123
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precarity and Reduction of Its Impact on the Mental Health of Health Students
- ClinicalTrials.gov ID
- NCT07539207
- Acronym / sponsor ID
- PRISMES / C25-114
- Conditions
- Mental Health (Depression), Mental Health, Quality of Lifte
- Keywords
- university student, economic precarity, mental health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the Unit 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.
Detailed description
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.
Choice of the 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Enrollment as a health student at the Faculty of Health, Université de Rouen Normandie (any program or discipline).
- Age between 18 and 30 years.
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Mental Health and Well-being Support for Financially Vulnerable Health StudentThe 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. | Behavioural | four individual psychological consultations., one psychological consultation and two collective workshops on stress and budget management, two collective workshops focused on stress and budget management, combined with two sophrology sessi |
Primary outcome
Participation rate in the offered sessions is defined as the ratio between the total number of sessions
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 33095252Wathelet 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.
- Background: PubMed 28189805Baggio 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.
- Background: PubMed 31270123Pisaniello 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Mental Health and Well-being Support for Financially Vulnerable Health Student in people with Mental Health (Depression) and Mental Health, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate in the offered sessions is defined as the ratio between the total number of sessions (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07539207, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.