NCT07110792

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
Last Updated

August 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

July 23, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

perceived stressprosocial skillshealth studentsmindfulnesscompassion skillspsychological well-beingMBCT-L

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

EXPERIMENTAL

In this arm, participants complete clinical questionnaires

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

Neurobiological arm

EXPERIMENTAL

In this arm, participants complete either MRI and or blood sample

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

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

Clinical armNeurobiological arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Geneva

Geneva, Canton of Geneva, 1202, Switzerland

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: The intervention is compared to a waiting list group.
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

Locations