Mental Health Issuee-SMILENCT07110792
A Mindfulness-based Intervention to Reduce Stress and Improve Prosocial Skills for Health-care Students
A study testing Mindfulness-based Cognitive Therapy for Life (MBCT-L) in people with Mental Health Issue, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Mindfulness-based Cognitive Therapy for Life (MBCT-L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2022to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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)
- Conditions
- Mental Health Issue
- Being tested
- Mindfulness-based Cognitive Therapy for Life (MBCT-L)
- Keywords
- perceived stress, prosocial skills, health students, mindfulness, compassion skills, psychological well-being, MBCT-L
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Clinical arm | Experimental | In this arm, participants complete clinical questionnaires Receives: Other: Mindfulness-based Cognitive Therapy for Life (MBCT-L) |
| Neurobiological arm | Experimental | In this arm, participants complete either MRI and or blood sample Receives: Other: Mindfulness-based Cognitive Therapy for Life (MBCT-L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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
Measured: 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
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Work package 3 (WP3) - Metabolic
Metabolic constitutive profiles
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Work package 3 (WP3) - Lipid
Lipid signalling profiles
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Secondary outcomes (12)
WP1 - Trait mindfulness
Questionnaire: Five Facets of Mindfulness Questionnaire (FFMQ); score range: 39-195.
A higher score indicates a higher level of trait mindfulness
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Compassion
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
Measured: T0: baseline T1: 3 months after T0 T2: 9 months after T0
WP1 - Psychological well-being
Psychological well-being scale; score range 18-108. A higher score indicates a greater psychological well-being
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Insomnia
Sleep condition indicator; score range: 0-32 A higher score corresponds to better sleep
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Anxiety and depression
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
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Satisfaction with studies
Scale of satisfaction with Studies; score range 5-35. A higher score indicates a greater degree of contentment with one's academic experience
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Resilience
Brief Resilience Scale; score range: 6-30. A higher score indicates a higher level of resilience
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP2 - Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)
Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP2 - Resting State neuroimaging data
Resting State neuroimaging data
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP3 - Cortisol
Capillary and blood cortisol
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP3 - Oxytocine
Oxytocine
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP3 - Stress and inflammatory markers
Stress and inflammatory markers
Measured: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Feb 2022
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The intervention is compared to a waiting list group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Swiss National Science Foundation
- Responsible party
- Principal investigator, Camille Nemitz Piguet, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110792
- Sponsor's protocol ID
- 2021-02059
- Acronym
- e-SMILE
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07110792
- Acronym / sponsor ID
- e-SMILE / 2021-02059
- Conditions
- Mental Health Issue
- Keywords
- perceived stress, prosocial skills, health students, mindfulness, compassion skills, psychological well-being, MBCT-L
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Swiss National Science Foundation
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention is compared to a waiting list group.
| Arm | Type | Receives |
|---|---|---|
| Clinical arm | Experimental | Other: Mindfulness-based Cognitive Therapy for Life (MBCT-L)In this arm, participants complete clinical questionnaires |
| Neurobiological arm | Experimental | Other: Mindfulness-based Cognitive Therapy for Life (MBCT-L)In this arm, participants complete either MRI and or blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Cognitive Therapy for Life (MBCT-L)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 | Other | Clinical arm, Neurobiological arm |
Primary outcome
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)
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).
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
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
Work package 3 (WP3) - Metabolic
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Metabolic constitutive profiles
Work package 3 (WP3) - Lipid
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Lipid signalling profiles
12 secondary outcomes
WP1 - Trait mindfulness
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Compassion
Time frame: T0: baseline T1: 3 months after T0 T2: 9 months after T0
WP1 - Psychological well-being
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Insomnia
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Anxiety and depression
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Satisfaction with studies
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP1 - Resilience
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
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
WP2 - Resting State neuroimaging data
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP3 - Cortisol
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP3 - Oxytocine
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
WP3 - Stress and inflammatory markers
Time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Cognitive Therapy for Life (MBCT-L) in people with Mental Health Issue, run by University of Geneva, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work package 1 (WP1) - Perceived stress (time frame: T0: baseline T1: 3 months from T0 T2: 9 months from T0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.