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A Mindfulness-based Intervention to Reduce Stress and Improve Prosocial Skills for Health-care Students

A Mindfulness-based Intervention to Reduce Stress and Improve Prosocial Skills for Health-care Students : a Translational RCT Integrating Clinical, Neuroimaging and Biomedical Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07110792
Acronym
e-SMILE
Enrollment
161
Registered
2025-08-08
Start date
2022-02-01
Completion date
2024-08-15
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Issue

Keywords

perceived stress, prosocial skills, health students, mindfulness, compassion skills, psychological well-being, MBCT-L

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.

Detailed description

This study is led jointly by Prof. C. Nemitz-Piguet, Dr F. Jermann, and Prof. S. Rudaz, who serve as co-principal investigators. This study is funded by the Swiss National Science Foundation (Grant number: 32003B\_205111 / 1)

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

Sponsors

Geneva University Hospital, Geneva, Switzerland
CollaboratorUNKNOWN
SNF Swiss National Foundation
CollaboratorUNKNOWN
University of Geneva, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Intervention model description

The intervention is compared to a waiting list group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Work package 1 (WP1) - Perceived stressT0: baseline T1: 3 months from T0 T2: 9 months from T0Perceived stress as measured by the Perceived Stress Scale (PSS; score range: 0 -56; a higher score indicates a higher perceived stress level)
Work package 1 (WP1) - Prosocial skillsT0: baseline T1: 3 months from T0 T2: 9 months from T0Prosocial skills as measured by the Prosocialness Scale for Adults (PBS; score range: 16-80; a higher score indicate a greater tendency towards prosocial behaviors).
Work package 2 (WP2) - Socio-affective Video Task with Resting State (SoVT-Rest)T0: baseline T1: 3 months from T0 T2: 9 months from T0Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the SOVT-Rest
Work package 2 (WP2) - Montreal Imaging Stress Task (MIST)T0: baseline T1: 3 months from T0 T2: 9 months from T0Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the MIST
Work package 3 (WP3) - MetabolicT0: baseline T1: 3 months from T0 T2: 9 months from T0Metabolic constitutive profiles
Work package 3 (WP3) - LipidT0: baseline T1: 3 months from T0 T2: 9 months from T0Lipid signalling profiles

Secondary

MeasureTime frameDescription
WP1 - ResilienceT0: baseline T1: 3 months from T0 T2: 9 months from T0Brief Resilience Scale; score range: 6-30. A higher score indicates a higher level of resilience
WP2 - Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)T0: baseline T1: 3 months from T0 T2: 9 months from T0Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)
WP2 - Resting State neuroimaging dataT0: baseline T1: 3 months from T0 T2: 9 months from T0Resting State neuroimaging data
WP1 - CompassionT0: baseline T1: 3 months after T0 T2: 9 months after T0Sussex-Oxford Compassion Scale; compassion for the self; score range: 20-120 ; compassion for others; score range: 20-120. A higher score indicates a greater level of compassion
WP3 - OxytocineT0: baseline T1: 3 months from T0 T2: 9 months from T0Oxytocine
WP3 - Stress and inflammatory markersT0: baseline T1: 3 months from T0 T2: 9 months from T0Stress and inflammatory markers
WP3 - CortisolT0: baseline T1: 3 months from T0 T2: 9 months from T0Capillary and blood cortisol
WP1 - Psychological well-beingT0: baseline T1: 3 months from T0 T2: 9 months from T0Psychological well-being scale; score range 18-108. A higher score indicates a greater psychological well-being
WP1 - Trait mindfulnessT0: baseline T1: 3 months from T0 T2: 9 months from T0Questionnaire: Five Facets of Mindfulness Questionnaire (FFMQ); score range: 39-195. A higher score indicates a higher level of trait mindfulness
WP1 - InsomniaT0: baseline T1: 3 months from T0 T2: 9 months from T0Sleep condition indicator; score range: 0-32 A higher score corresponds to better sleep
WP1 - Anxiety and depressionT0: baseline T1: 3 months from T0 T2: 9 months from T0Hospital Anxiety and Depression Scale; score range: 0-21 for anxiety and 0-21 for depression subscale. Higher scores correspond to higher anxiety and depression
WP1 - Satisfaction with studiesT0: baseline T1: 3 months from T0 T2: 9 months from T0Scale of satisfaction with Studies; score range 5-35. A higher score indicates a greater degree of contentment with one's academic experience

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026