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Completed

NCT Number: NCT07110792

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

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.

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Key information

Conditions

Mental Health Issue Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Geneva

Geneva, Canton of Geneva, 1202, Switzerland

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-based Cognitive Therapy for Life (MBCT-L)

Other

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

Primary outcomes

  1. Work package 1 (WP1) - Perceived stress

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Perceived stress as measured by the Perceived Stress Scale (PSS; score range: 0 -56; a higher score indicates a higher perceived stress level)

  2. Work package 1 (WP1) - Prosocial skills

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    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).

  3. Work package 2 (WP2) - Socio-affective Video Task with Resting State (SoVT-Rest)

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the SOVT-Rest

  4. Work package 2 (WP2) - Montreal Imaging Stress Task (MIST)

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the MIST

  5. Work package 3 (WP3) - Metabolic

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Metabolic constitutive profiles

  6. Work package 3 (WP3) - Lipid

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Lipid signalling profiles

Secondary outcomes

  1. WP1 - Trait mindfulness

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Questionnaire: Five Facets of Mindfulness Questionnaire (FFMQ); score range: 39-195.

    A higher score indicates a higher level of trait mindfulness

  2. WP1 - Compassion

    Time frame: T0: baseline T1: 3 months after T0 T2: 9 months after T0

    Sussex-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

  3. WP1 - Psychological well-being

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Psychological well-being scale; score range 18-108. A higher score indicates a greater psychological well-being

  4. WP1 - Insomnia

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Sleep condition indicator; score range: 0-32 A higher score corresponds to better sleep

  5. WP1 - Anxiety and depression

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Hospital Anxiety and Depression Scale; score range: 0-21 for anxiety and 0-21 for depression subscale. Higher scores correspond to higher anxiety and depression

  6. WP1 - Satisfaction with studies

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Scale of satisfaction with Studies; score range 5-35. A higher score indicates a greater degree of contentment with one's academic experience

  7. WP1 - Resilience

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Brief Resilience Scale; score range: 6-30. A higher score indicates a higher level of resilience

  8. WP2 - Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)

  9. WP2 - Resting State neuroimaging data

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Resting State neuroimaging data

  10. WP3 - Cortisol

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Capillary and blood cortisol

  11. WP3 - Oxytocine

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Oxytocine

  12. WP3 - Stress and inflammatory markers

    Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0

    Stress and inflammatory markers

Sponsors and collaborators

Lead sponsor

University of Geneva, Switzerland

Other

Collaborators

  • Swiss National Science Foundation
  • University Hospital, Geneva

Registry information

Official study title

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

Acronym: e-SMILE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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