A Mindfulness-based Intervention to Reduce Stress and Improve Prosocial Skills for Health-care Students
e-SMILE
1 other identifier
interventional
161
1 country
1
Brief Summary
We aim to study the clinical immediate and long-term efficacy of a web-delivered MBCT-L protocol targeting bachelor and master health-care students in Geneva, as well as to study the correlations of clinical, neuroimaging and biomedical effects of such an intervention. Primary objective: To evaluate the immediate and long-term effect of MBCT-L on reducing perceived stress and improving pro-social skills for health-care students, compared to a control group. Secondary objective: To evaluate the immediate and long-term effect of MBCT-L on trait mindfulness, compassion, global psychological well-being, sleep quality, anxiety, depression, satisfaction in studies and resilience, to broaden the clinical understanding of the impact of such an intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2024
CompletedFirst Submitted
Initial submission to the registry
July 23, 2025
CompletedFirst Posted
Study publicly available on registry
August 8, 2025
CompletedAugust 8, 2025
July 1, 2025
2.5 years
July 23, 2025
July 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Work package 1 (WP1) - Perceived stress
Perceived stress as measured by the Perceived Stress Scale (PSS; score range: 0 -56; a higher score indicates a higher perceived stress level)
T0: baseline T1: 3 months from T0 T2: 9 months from T0
Work package 1 (WP1) - Prosocial skills
Prosocial skills as measured by the Prosocialness Scale for Adults (PBS; score range: 16-80; a higher score indicate a greater tendency towards prosocial behaviors).
T0: baseline T1: 3 months from T0 T2: 9 months from T0
Work package 2 (WP2) - Socio-affective Video Task with Resting State (SoVT-Rest)
Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the SOVT-Rest
T0: baseline T1: 3 months from T0 T2: 9 months from T0
Work package 2 (WP2) - Montreal Imaging Stress Task (MIST)
Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the MIST
T0: baseline T1: 3 months from T0 T2: 9 months from T0
Work package 3 (WP3) - Metabolic
Metabolic constitutive profiles
T0: baseline T1: 3 months from T0 T2: 9 months from T0
Work package 3 (WP3) - Lipid
Lipid signalling profiles
T0: baseline T1: 3 months from T0 T2: 9 months from T0
Secondary Outcomes (12)
WP1 - Trait mindfulness
T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Compassion
T0: baseline T1: 3 months after T0 T2: 9 months after T0
WP1 - Psychological well-being
T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Insomnia
T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Anxiety and depression
T0: baseline T1: 3 months from T0 T2: 9 months from T0
- +7 more secondary outcomes
Study Arms (2)
Clinical arm
EXPERIMENTALIn this arm, participants complete clinical questionnaires
Neurobiological arm
EXPERIMENTALIn this arm, participants complete either MRI and or blood sample
Interventions
The MBCT-L (Bernard, Cullen \& Kuyken, 2017) intervention is an 8-week group intervention, comprising a pre-course orientation session, eight 2-hour sessions, and a half-day silent session. MBCT-L was delivered synchronously online. MBCT-L group were led by one MBCT-L instructor
Eligibility Criteria
You may qualify if:
- Eligibility criteria were applied to recruit second, third- or fourth-year health students in Geneva, Switzerland, who were at least 18 years old, had some interest in mindfulness, were available for the duration of the study, and agreed on refraining from regular mindfulness practice until allocated to the MBCT-L group.
You may not qualify if:
- Students were excluded if they had a current depressive episode, post-traumatic stress disorder, psychotic disorder, or substance dependency as identified through the Mini international Neuropsychiatric Interview (MINI). All participants received oral and written information about the trial and signed the informed consent form prior to the beginning of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Geneva, Switzerlandlead
- Geneva University Hospital, Geneva, Switzerlandcollaborator
- SNF Swiss National Foundationcollaborator
Study Sites (1)
University of Geneva
Geneva, Canton of Geneva, 1202, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, PD
Study Record Dates
First Submitted
July 23, 2025
First Posted
August 8, 2025
Study Start
February 1, 2022
Primary Completion
August 15, 2024
Study Completion
August 15, 2024
Last Updated
August 8, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share