Mental Well-beingPS-MHFANCT07161284
Impact of Mental Health First Aid-trained Peers on the Mental Well-being of First-year Medical Residents.
A study testing Exposition to trained peer-support registrars for a year in people with Mental Well-being, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Medical students, especially those in postgraduate training, face a complex array of challenges such as fatigue; work-life balance conflicts; difficulties managing dual hierarchies (hospital and university). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Well-being
- What is being tested?
- Exposition to trained peer-support registrars for a year
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2025to Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject to the non-opposition of the residents, all medical residents entering their first and second year of specialized studies (DES) on November 1, 2025, in the city of Lyon will be included in the study.
Who cannot join
- refusal to participate AND in the unlikely cases where:
- subject under guardianship or curatorship;
- subject unable to give free and informed consent;
- subject under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Urgences Psychiatriques Hôpital Edouard Herriot, GH Centre
Lyon, France, 69008
About this study
Medical students, especially those in postgraduate training, face a complex array of challenges such as fatigue; work-life balance conflicts; difficulties managing dual hierarchies (hospital and university). Surprisingly, residents receive little to no dedicated training in recognizing and managing psychiatric disorders, except for psychiatry residents. This gap is exacerbated by persistent stigma towards psychiatric conditions. The Mental Health First Aid (MHFA) training approach could offer an innovative solution, addressing the root of the problem. This prospective, single-center cohort study aims to compare (1) the mental well-being of first-year specialty residents in the Lyon subdivision exposed to MHFA-trained peers; with (2) the mental well-being of unexposed second-year specialty residents. The hypothesis is that exposure to peers trained in MHFA improves well-being and reduces symptoms of burnout, depression, and anxiety at 3, 6, 9, and 12 months among peer residents.
- Conditions
- Mental Well-being
- Being tested
- Exposition to trained peer-support registrars for a year
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposition to trained peer-support registrars for a yearOther
Exposition to trained peer-support registrars for a year
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Experimental | Medical residents entering their first year of specialized studies (DES) on November 1, 2025, in the city of Lyon, France. Receives: Other: Exposition to trained peer-support registrars for a year |
| Not exposed | No intervention | Medical residents entering their second year of specialized studies (DES) on November 1, 2025, in the city of Lyon, France. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being
As measured by the total score on the WEMWBS (Warwick-Edinburgh Mental Well-being Scale), a self-questionnaire. 5 point Likert scale (1-4); 14 questions
Measured: Measured at Month 12
Secondary outcomes (6)
Well-being
As measured by the total score on the WEMWBS (Warwick-Edinburgh Mental Well-being Scale), a self-questionnaire. 5 point Likert scale (1-4); 14 questions
Measured: Measured at baseline, Month 3, Month 6 and Month 9
Anxiety
As measured by anxiety subscore of the HAD (Hospital Anxiety and Depression scale), a self-questionnaire. 4 point Likert scale (0-3); 7 questions
Measured: Measured at baseline, Month 3, Month 6, Month 9, Month 12
Depression
As measured by depression subscore of the HAD (Hospital Anxiety and Depression scale), a self-questionnaire. 4 point Likert scale (0-3); 7 questions
Measured: Measured at baseline, Month 3, Month 6, Month 9, Month 12
Burn-out
As measured by the MBI (Maslach Burnout Inventory), a self-questionnaire. 7 point Likert scale (0-6); 22 questions.
Measured: Measured at baseline, Month 3, Month 6, Month 9, Month 12
Impact on well-being according to gender
Differentiated impact on well-being according to gender measured by the total score on the WEMWBS (Warwick-Edinburgh Mental Well-being Scale, a self-questionnaire. 5 point Likert scale (1-4); 14 questions), analyzed via Group x Gender interaction effect.
Measured: Measured at baseline, Month 3, Month 6, Month 9, Month 12
Impact on well-being according to speciality
Differentiated impact on well-being according to speciality measured by the total score on the WEMWBS (Warwick-Edinburgh Mental Well-being Scale, a self-questionnaire. 5 point Likert scale (1-4); 14 questions), analyzed via Group x Speciality interaction effect.
Measured: Measured at baseline, Month 3, Month 6, Month 9, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start21 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Well-beingStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161284
- Sponsor's protocol ID
- 69HCL25_0576
- Acronym
- PS-MHFA
- Status last verified
- Dec 2025
- First submitted
- 25 Aug 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bailly G, Barbalat G, Danckaert J, Franck N, Guillotin F, Poncin A, Nohales L, Poulet E, Maillet A, Celerier I, L'Helgouarc'h K, Rode G, Paparel P, Pham BN, Leaune E. Peer support based on Mental Health First Aid for medical residents in Lyon, France: protocol for a non-randomised controlled mixed-methods study. BMJ Open. 2026 Jul 29;16(7):e120352. doi: 10.1136/bmjopen-2026-120352.
PubMed 42526934
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mental Health First Aid-trained Peers on the Mental Well-being of First-year Medical Residents.
- ClinicalTrials.gov ID
- NCT07161284
- Acronym / sponsor ID
- PS-MHFA / 69HCL25_0576
- Conditions
- Mental Well-being
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Sep 2025 (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.
Medical students, especially those in postgraduate training, face a complex array of challenges such as fatigue; work-life balance conflicts; difficulties managing dual hierarchies (hospital and university). Surprisingly, residents receive little to no dedicated training in recognizing and managing psychiatric disorders, except for psychiatry residents. This gap is exacerbated by persistent stigma towards psychiatric conditions. The Mental Health First Aid (MHFA) training approach could offer an innovative solution, addressing the root of the problem. This prospective, single-center cohort study aims to compare (1) the mental well-being of first-year specialty residents in the Lyon subdivision exposed to MHFA-trained peers; with (2) the mental well-being of unexposed second-year specialty residents. The hypothesis is that exposure to peers trained in MHFA improves well-being and reduces symptoms of burnout, depression, and anxiety at 3, 6, 9, and 12 months among peer residents.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | Experimental | Other: Exposition to trained peer-support registrars for a yearMedical residents entering their first year of specialized studies (DES) on November 1, 2025, in the city of Lyon, France. |
| Not exposed | No intervention | –Medical residents entering their second year of specialized studies (DES) on November 1, 2025, in the city of Lyon, France. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subject to the non-opposition of the residents, all medical residents entering their first and second year of specialized studies (DES) on November 1, 2025, in the city of Lyon will be included in the study.
Key exclusion criteria (4 listed)
- refusal to participate AND in the unlikely cases where:
- subject under guardianship or curatorship;
- subject unable to give free and informed consent;
- subject under legal protection
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 |
|---|---|---|
| Exposition to trained peer-support registrars for a yearExposition to trained peer-support registrars for a year | Other | Exposed |
Primary outcome
Well-being
Time frame: Measured at Month 12
As measured by the total score on the WEMWBS (Warwick-Edinburgh Mental Well-being Scale), a self-questionnaire. 5 point Likert scale (1-4); 14 questions
6 secondary outcomes
Well-being
Time frame: Measured at baseline, Month 3, Month 6 and Month 9
Anxiety
Time frame: Measured at baseline, Month 3, Month 6, Month 9, Month 12
Depression
Time frame: Measured at baseline, Month 3, Month 6, Month 9, Month 12
Burn-out
Time frame: Measured at baseline, Month 3, Month 6, Month 9, Month 12
Impact on well-being according to gender
Time frame: Measured at baseline, Month 3, Month 6, Month 9, Month 12
Impact on well-being according to speciality
Time frame: Measured at baseline, Month 3, Month 6, Month 9, Month 12
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 30 Dec 2025.
- Derived from this study: PubMed 42526934Bailly G, Barbalat G, Danckaert J, Franck N, Guillotin F, Poncin A, Nohales L, Poulet E, Maillet A, Celerier I, L'Helgouarc'h K, Rode G, Paparel P, Pham BN, Leaune E. Peer support based on Mental Health First Aid for medical residents in Lyon, France: protocol for a non-randomised controlled mixed-methods study. BMJ Open. 2026 Jul 29;16(7):e120352. doi: 10.1136/bmjopen-2026-120352.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposition to trained peer-support registrars for a year in people with Mental Well-being, run by Hospices Civils de Lyon 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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being (time frame: Measured at Month 12). 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 NCT07161284, which also lists 1 linked publication.
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 30 Dec 2025.