Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-14 @ 9:44 AM
Study NCT ID:
NCT02334020
Status:
UNKNOWN
Last Update Posted:
2015-04-28
First Post:
2014-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Impact of the Mental Health First-Aid Training Course in Danish Employees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 538}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-25', 'studyFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increased confidence in help-giving behaviour as measured by comparing the intervention group after having attended the training course with the control group. (questionnaire)', 'timeFrame': '6 months', 'description': 'Continuous outcome measures will be analyzed using generalized linear models and dichotomous outcome measures will be analyzed using binary logistic regression. Data will be analysed using IBM SPSS version 22.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mental illness', 'training', 'support', 'Mental Health'], 'conditions': ['Mental Health Impairment']}, 'referencesModule': {'references': [{'pmid': '37606172', 'type': 'DERIVED', 'citation': 'Richardson R, Dale HE, Robertson L, Meader N, Wellby G, McMillan D, Churchill R. Mental Health First Aid as a tool for improving mental health and well-being. Cochrane Database Syst Rev. 2023 Aug 22;8(8):CD013127. doi: 10.1002/14651858.CD013127.pub2.'}, {'pmid': '26837214', 'type': 'DERIVED', 'citation': 'Jensen KB, Morthorst BR, Vendsborg PB, Hjorthoj C, Nordentoft M. Effectiveness of Mental Health First Aid training in Denmark: a randomized trial in waitlist design. Soc Psychiatry Psychiatr Epidemiol. 2016 Apr;51(4):597-606. doi: 10.1007/s00127-016-1176-9. Epub 2016 Feb 2.'}, {'pmid': '25884517', 'type': 'DERIVED', 'citation': 'Jensen KB, Morthorst BR, Vendsborg PB, Hjorthoj CR, Nordentoft M. The effect of the mental health first-aid training course offered employees in Denmark: study protocol for a randomized waitlist-controlled superiority trial mixed with a qualitative study. BMC Psychiatry. 2015 Apr 14;15:80. doi: 10.1186/s12888-015-0466-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is evaluate the effect of the Mental Health First-aid training course on a Danish population of employees.', 'detailedDescription': 'Background:\n\nStudies show a high and growing prevalence of mental disorders in the population worldwide. 25 % of the general population in Europe will during their lifetime experience symptoms related to a mental disorder. The Mental Health First Aid concept (MHFA) was founded in 2000 in Australia by Kitchener and Jorm, in order to provide the population with mental health first aid skills.\n\nObjective:\n\nThe aim of the concept is, through an educational intervention (course), to increase confidence in how to help people suffering from mental health problems. Further, secondary aims are to increase the mental health literacy of the public by increasing knowledge, reduce stigma and initiate more supportive actions leading towards professional help. An investigation of the effect of MHFA offered a Danish population is needed.\n\nDesign and Methods:\n\nThe design is a randomized controlled superiority trial, in which 500 participants will be allocated to either the intervention group or the control group. The control group will attend the course six months later, hence waiting list design. From fall 2013 to spring 2014 participants will be educated in Mental Health First-aid following a manualized, two days MHFA course. All the participants will answer a questionnaire at base-line and at 6 months follow-up. The questionnaire is a back-translation of the questionnaire used in Australian trials. The trial will be complemented by a qualitative study, in which focus groups will be carried out.\n\nOutcome:\n\nThe primary outcome measure is increased confidence in help-giving behavior among the participants. Secondary outcome will be increased knowledge of and improved positive attitudes towards people suffering from a mental health problem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\npeople, who in their line of work are in contact with many different individuals\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT02334020', 'briefTitle': 'Investigating the Impact of the Mental Health First-Aid Training Course in Danish Employees', 'organization': {'class': 'OTHER', 'fullName': 'Mental Health Services in the Capital Region, Denmark'}, 'officialTitle': 'Effectiveness of Mental Health First-Aid Training in Denmark. A Randomized Controlled Trial With a Six-Month Follow-Up Supplemented With a Qualitative Study', 'orgStudyIdInfo': {'id': 'MHFA Evaluation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training course', 'description': '12 hour training course in Mental Health First-aid', 'interventionNames': ['Other: Mental Health First-aid']}, {'type': 'OTHER', 'label': 'Waiting list', 'description': 'Waiting list design, hence delayed offering of Mental Health First-aid', 'interventionNames': ['Other: Mental Health First-aid']}], 'interventions': [{'name': 'Mental Health First-aid', 'type': 'OTHER', 'description': '2 days training course providing information on severe mental illness, in order to make people able to support in situations of crisis', 'armGroupLabels': ['Training course', 'Waiting list']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Mental Health Center Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Merete Nordentoft, Prof. Dr.med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mental Health Centre, in the capital region of Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Dr. Med Sc.', 'investigatorFullName': 'Merete Nordentoft', 'investigatorAffiliation': 'Mental Health Services in the Capital Region, Denmark'}}}}