Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT07110792
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mindfulness-based Intervention to Reduce Stress and Improve Prosocial Skills for Health-care Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099025', 'term': 'Mindfulness-Based Cognitive Therapy'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The intervention is compared to a waiting list group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work package 1 (WP1) - Perceived stress', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Perceived stress as measured by the Perceived Stress Scale (PSS; score range: 0 -56; a higher score indicates a higher perceived stress level)'}, {'measure': 'Work package 1 (WP1) - Prosocial skills', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': '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).'}, {'measure': 'Work package 2 (WP2) - Socio-affective Video Task with Resting State (SoVT-Rest)', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the SOVT-Rest'}, {'measure': 'Work package 2 (WP2) - Montreal Imaging Stress Task (MIST)', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the MIST'}, {'measure': 'Work package 3 (WP3) - Metabolic', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Metabolic constitutive profiles'}, {'measure': 'Work package 3 (WP3) - Lipid', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Lipid signalling profiles'}], 'secondaryOutcomes': [{'measure': 'WP1 - Trait mindfulness', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Questionnaire: Five Facets of Mindfulness Questionnaire (FFMQ); score range: 39-195.\n\nA higher score indicates a higher level of trait mindfulness'}, {'measure': 'WP1 - Compassion', 'timeFrame': 'T0: baseline T1: 3 months after T0 T2: 9 months after T0', 'description': 'Sussex-Oxford Compassion Scale; compassion for the self; score range: 20-120 ; compassion for others; score range: 20-120.\n\nA higher score indicates a greater level of compassion'}, {'measure': 'WP1 - Psychological well-being', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Psychological well-being scale; score range 18-108. A higher score indicates a greater psychological well-being'}, {'measure': 'WP1 - Insomnia', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Sleep condition indicator; score range: 0-32 A higher score corresponds to better sleep'}, {'measure': 'WP1 - Anxiety and depression', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': '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'}, {'measure': 'WP1 - Satisfaction with studies', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': "Scale of satisfaction with Studies; score range 5-35. A higher score indicates a greater degree of contentment with one's academic experience"}, {'measure': 'WP1 - Resilience', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Brief Resilience Scale; score range: 6-30. A higher score indicates a higher level of resilience'}, {'measure': 'WP2 - Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)'}, {'measure': 'WP2 - Resting State neuroimaging data', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Resting State neuroimaging data'}, {'measure': 'WP3 - Cortisol', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Capillary and blood cortisol'}, {'measure': 'WP3 - Oxytocine', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Oxytocine'}, {'measure': 'WP3 - Stress and inflammatory markers', 'timeFrame': 'T0: baseline T1: 3 months from T0 T2: 9 months from T0', 'description': 'Stress and inflammatory markers'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perceived stress', 'prosocial skills', 'health students', 'mindfulness', 'compassion skills', 'psychological well-being', 'MBCT-L'], 'conditions': ['Mental Health Issue']}, 'descriptionModule': {'briefSummary': '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.\n\nPrimary 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.\n\nSecondary 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.', 'detailedDescription': 'This study is led jointly by Prof. C. Nemitz-Piguet, Dr F. Jermann, and Prof. S. Rudaz, who serve as co-principal investigators.\n\nThis study is funded by the Swiss National Science Foundation (Grant number: 32003B\\_205111 / 1)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT07110792', 'acronym': 'e-SMILE', 'briefTitle': 'A Mindfulness-based Intervention to Reduce Stress and Improve Prosocial Skills for Health-care Students', 'organization': {'class': 'OTHER', 'fullName': 'University of Geneva, Switzerland'}, 'officialTitle': 'A Mindfulness-based Intervention to Reduce Stress and Improve Prosocial Skills for Health-care Students : a Translational RCT Integrating Clinical, Neuroimaging and Biomedical Outcomes', 'orgStudyIdInfo': {'id': '2021-02059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical arm', 'description': 'In this arm, participants complete clinical questionnaires', 'interventionNames': ['Other: Mindfulness-based Cognitive Therapy for Life (MBCT-L)']}, {'type': 'EXPERIMENTAL', 'label': 'Neurobiological arm', 'description': 'In this arm, participants complete either MRI and or blood sample', 'interventionNames': ['Other: Mindfulness-based Cognitive Therapy for Life (MBCT-L)']}], 'interventions': [{'name': 'Mindfulness-based Cognitive Therapy for Life (MBCT-L)', 'type': 'OTHER', 'description': '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.\n\nMBCT-L was delivered synchronously online. MBCT-L group were led by one MBCT-L instructor', 'armGroupLabels': ['Clinical arm', 'Neurobiological arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1202', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Geneva University Hospital, Geneva, Switzerland', 'class': 'UNKNOWN'}, {'name': 'SNF Swiss National Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, PD', 'investigatorFullName': 'Camille Nemitz Piguet', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}