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

Not Applicable

Completed

• Conditions: Mental Health Issue

• Registration Number: NCT07110792
• Lead Sponsor: University of Geneva, Switzerland

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)

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Work package 1 (WP1) - Perceived stress	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)
Work package 1 (WP1) - Prosocial skills	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).
Work package 2 (WP2) - Socio-affective Video Task with Resting State (SoVT-Rest)	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
Work package 2 (WP2) - Montreal Imaging Stress Task (MIST)	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
Work package 3 (WP3) - Metabolic	T0: baseline T1: 3 months from T0 T2: 9 months from T0	Metabolic constitutive profiles
Work package 3 (WP3) - Lipid	T0: baseline T1: 3 months from T0 T2: 9 months from T0	Lipid signalling profiles

Secondary Outcome Measures

Name	Time	Method
WP1 - Trait mindfulness	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
WP1 - Compassion	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
WP1 - Psychological well-being	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
WP1 - Insomnia	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
WP1 - Anxiety and depression	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
WP1 - Satisfaction with studies	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
WP1 - Resilience	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
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 T0	Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)
WP2 - Resting State neuroimaging data	T0: baseline T1: 3 months from T0 T2: 9 months from T0	Resting State neuroimaging data
WP3 - Cortisol	T0: baseline T1: 3 months from T0 T2: 9 months from T0	Capillary and blood cortisol
WP3 - Oxytocine	T0: baseline T1: 3 months from T0 T2: 9 months from T0	Oxytocine
WP3 - Stress and inflammatory markers	T0: baseline T1: 3 months from T0 T2: 9 months from T0	Stress and inflammatory markers

Trial Locations

Locations (1)

University of Geneva; 🇨🇭 Geneva, Switzerland