NCT07161284

Brief 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). 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

August 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 21, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

August 25, 2025

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 at Month 12

Secondary Outcomes (6)

  • Well-being

    Measured at baseline, Month 3, Month 6 and Month 9

  • Anxiety

    Measured at baseline, Month 3, Month 6, Month 9, Month 12

  • Depression

    Measured at baseline, Month 3, Month 6, Month 9, Month 12

  • Burn-out

    Measured at baseline, Month 3, Month 6, Month 9, Month 12

  • Impact on well-being according to gender

    Measured at baseline, Month 3, Month 6, Month 9, Month 12

  • +1 more secondary outcomes

Study Arms (2)

Exposed

EXPERIMENTAL

Medical residents entering their first year of specialized studies (DES) on November 1, 2025, in the city of Lyon, France.

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.

Interventions

Exposition to trained peer-support registrars for a year

Exposed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Urgences Psychiatriques Hôpital Edouard Herriot, GH Centre

Lyon, France, 69008, France

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

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

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 8, 2025

Study Start

November 21, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations