Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-01-08 @ 12:41 AM
Study NCT ID:
NCT04610333
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2020-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
On Top of Everything
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 992}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version', 'timeFrame': 'Six months after baseline', 'description': 'Change in the score among the total study population'}], 'secondaryOutcomes': [{'measure': 'Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version', 'timeFrame': 'Three months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version', 'timeFrame': 'Three months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version', 'timeFrame': 'Six months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Perseived Stress Scale', 'timeFrame': 'Three months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Perseived Stress Scale', 'timeFrame': 'Six months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Depression Anxiety Stress Scale (DASS) - The short form version', 'timeFrame': 'Three months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Depression Anxiety Stress Scale (DASS) - The short form version', 'timeFrame': 'Six months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Brief Resilience Scale (BRS)', 'timeFrame': 'Three months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Brief Resilience Scale (BRS)', 'timeFrame': 'Six months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Three-Item Loneliness Scale (T-ILS)', 'timeFrame': 'Three months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Three-Item Loneliness Scale (T-ILS)', 'timeFrame': 'Six months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Experiences Questionnaire (EQ) - Decentering subscale', 'timeFrame': 'Three months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Experiences Questionnaire (EQ) - Decentering subscale', 'timeFrame': 'Six months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'EQ-5D', 'timeFrame': 'Three months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'EQ-5D', 'timeFrame': 'Six months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Karolinska Sleep Questionnaire - Modified version', 'timeFrame': 'Three months after baseline', 'description': 'Change in the score among the total study population'}, {'measure': 'Karolinska Sleep Questionnaire - Modified version', 'timeFrame': 'Six months after baseline', 'description': 'Change in the score among the total study population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['School-based intervention', 'Population-based preventive strategy', 'Public health'], 'conditions': ['Mental Health', 'Youth', 'Mindfulness', 'Stress']}, 'referencesModule': {'references': [{'pmid': '40789917', 'type': 'DERIVED', 'citation': 'Juul L, Frydenberg M, Bonde EH, Beck MS, Goetzsche K, Bruggisser S, Fjorback LO. Introducing a mindfulness-based intervention in school curriculum to 16-24-year-olds. A nationwide cluster-randomized trial. Npj Ment Health Res. 2025 Aug 11;4(1):37. doi: 10.1038/s44184-025-00150-w.'}, {'pmid': '36609335', 'type': 'DERIVED', 'citation': 'Beck MS, Juul L, Frydenberg M, Fjorback LO. On Top of Everything: a study protocol for a cluster-randomised controlled trial testing a teacher training programme to teach mindfulness among students in Danish upper secondary schools and schools of health and social care. Trials. 2023 Jan 6;24(1):17. doi: 10.1186/s13063-022-06920-7.'}]}, 'descriptionModule': {'briefSummary': "Our primary aim of this trial is to evaluate the effectiveness of a teacher training programme to teach mindfulness as part of regular classroom teaching in the total population of students in Danish upper secondary schools and schools of health and social care, respectively, on students' self-reported mental health at six-month follow-up.\n\nOur secondary aim is to evaluate the effectiveness of the teacher training programme to teach mindfulness in a vulnerable subgroup of students on their self-reported mental health at three and six months after baseline.", 'detailedDescription': 'The study is designed as a pragmatic cluster randomised two-arm trial including 43 Danish schools (30 upper secondary schools and 13 schools of health and social care). The schools included a total of 76 school teachers for teacher training (44 teachers from upper secondary schools and 32 teachers from schools of health and social care). Each included teacher will be asked to recruit a class of students (15-30 students) to test the effectiveness of the modified MBSR programme (in total approx. 1.000 students).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All students in the enrolled school classes\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04610333', 'briefTitle': 'On Top of Everything', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'On Top of Everything. A Study Protocol for a Cluster-Randomised Controlled Trial Testing a Teacher Training Programme to Teach Mindfulness Among Students in Danish Upper Secondary Schools and Schools of Health and Social Care', 'orgStudyIdInfo': {'id': '15092020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'School teacher training', 'description': 'Teacher training programme:\n\n* MBSR according to international standards (2.5 hours group session once a week in 8 weeks; a silence retreat day; and 45-60 minutes homework six days a week). Content in accordance with MBSR curriculum.\n* Four-day residental course\n* 3 x 2 seminar days\n\nModified MBSR programme delivered to the students:\n\n\\- 1hour group session once a week in 10 weeks taught by the educated teachers on class', 'interventionNames': ['Behavioral: Modified MBSR programme']}, {'type': 'NO_INTERVENTION', 'label': 'Usual practice'}], 'interventions': [{'name': 'Modified MBSR programme', 'type': 'BEHAVIORAL', 'description': '1 hour group session once a week in 10 weeks', 'armGroupLabels': ['School teacher training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8220', 'city': 'Aarhus', 'state': 'Brabrand', 'country': 'Denmark', 'facility': 'Danish Center for Mindfulness', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Lise Juul, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Center for Mindfulness'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}