Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-28 @ 11:09 PM
Study NCT ID:
NCT06385457
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The participants are partly masked. The control group will be masked; however, the intervention group will not be masked.\n\nThere is no care provider nor outcome assessor as all measures are self-reported and collected through online questionnaires.\n\nAnalyses of data and interpretation of results will be done masked.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Participants will be recruited via social media, and randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, will be measured at 2-, 6-, and 12-weeks post-randomization and analysed using the intention-to-treat approach.\n\nAccording to the investigators' power calculation, at least 3,142 participants (1,571 in each group) are required at follow-up 2 weeks after the randomization (primary endpoint). In the test phase, the investigators retrieved a response proportion of 64% for this follow-up survey. Assuming a similar retention proportion the investigators aim to include 4910 participants at baseline. The proportion of participants responding to the follow-up surveys will be regularly reviewed to evaluate if the assumption on retention is correct or if the number of participants included should be increased or decreased."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4910}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intentions of help-seeking', 'timeFrame': 'Baseline and randomization(T1), 6 weeks(T3) and 12 weeks (T4) after randomization.', 'description': 'As the investigators have developed the questions used to assess intentions of help-seeking no validated ranging of score exists.\n\nThe effects of Mindhelper on intentions to help-seeking are measured through surveys disseminated to the study participants. The primary assessment of effect is conduct at T3.'}, {'measure': 'Body Appreciation measured by the "2-items Short forms of the Body Appreciation Scale-2" (2-item BAS-2SF).', 'timeFrame': 'Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.', 'description': 'The BAS-2SF uses a 5-point Likert scale for responses, ranging from 1 (Never) to 5 (Always), thus for 2-item BAS-2SF the score ranges from 2 to 10. Higher scores indicate greater body appreciation.\n\nThe effects of Mindhelper on body appreciation are measured through surveys disseminated to the study participants. The primary assessment of effect is conduct at T2.'}], 'primaryOutcomes': [{'measure': 'General well-being measure by "The Well-Being Index WHO-5" (WHO5)', 'timeFrame': 'Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.', 'description': 'The WHO5 scores range between 0 and 100. The higher score, the higher level of well-being.\n\nThe effects of Mindhelper on well-being are measured through surveys disseminated to the study participants. The primary assessment of effect is conducted at T2.'}], 'secondaryOutcomes': [{'measure': 'Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS).', 'timeFrame': 'Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.', 'description': 'The SWEMWBS scores range from 7 to 35, and higher scores indicate higher levels of mental wellbeing.\n\nThe effects of Mindhelper on psychological functioning are measured through surveys disseminated to the study participants. The primary assessment of effect is conducted at T2.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-guided', 'Prevention', 'Well-being', 'eHealth', 'Promotion', 'Adolescents', 'Young adults', 'Body Appreciation'], 'conditions': ['Mental Health Issue', 'Well-Being', 'Adolescents', 'Young Adults', 'Online Intervention', 'Internet-Based Intervention', 'Randomized Controlled Trial', 'Body Dissatisfaction']}, 'referencesModule': {'references': [{'pmid': '35612877', 'type': 'BACKGROUND', 'citation': 'Hoffmann SH, Paldam Folker A, Buskbjerg M, Paldam Folker M, Huber Jezek A, Lyngso Svarta D, Nielsen Solvhoj I, Thygesen L. Potential of Online Recruitment Among 15-25-Year Olds: Feasibility Randomized Controlled Trial. JMIR Form Res. 2022 May 25;6(5):e35874. doi: 10.2196/35874.'}, {'pmid': '40929726', 'type': 'DERIVED', 'citation': 'Hoffmann SH, Kusier AO, Mairey IP, Folker AP, Thygesen LC. A Self-Guided Digital Mental Health Promotion Service Targeting Young People: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 10;14:e73736. doi: 10.2196/73736.'}]}, 'descriptionModule': {'briefSummary': 'In a two-armed randomized controlled trial 15-25-year-olds will be recruited via social media to evaluate the effectiveness of Mindhelper.dk; a Danish self-guided, digital, mental health service offering information, self-help tools, and guidance to young people. Participants will be randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, including well-being (WHO5), psychological functioning (SWEMWBS), help-seeking intentions, and body appreciation (2-item BAS-2SF), will be measured at 2-, 6-, and 12-weeks post-randomization and analyzed using the intention-to-treat approach. Qualitative interviews with intervention group participants will provide complementary insights, and a cost-effectiveness analysis will also be conducted.', 'detailedDescription': 'A study protocol will be made publicly accessible upon acceptance for publication in a suitable journal'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Men, women, and others', 'healthyVolunteers': True, 'eligibilityCriteria': '-Aged 15-25'}, 'identificationModule': {'nctId': 'NCT06385457', 'briefTitle': 'The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People', 'orgStudyIdInfo': {'id': '24-2933'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period.', 'interventionNames': ['Behavioral: Mindhelper- A national youth mental health promotion website']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.'}], 'interventions': [{'name': 'Mindhelper- A national youth mental health promotion website', 'type': 'BEHAVIORAL', 'description': 'Mindhelper is an open-access, digital self-directed mental health service that provides information, self-help tools and guidance to young people in Denmark.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1455', 'city': 'Copenhagen', 'state': 'Copenhagen K', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sofie H Hoffmann', 'role': 'CONTACT', 'email': 'sohh@sdu.dk', 'phone': '65 50 77 34', 'phoneExt': '+45'}, {'name': 'Lau C Thygesen', 'role': 'CONTACT', 'email': 'lct@sdu.dk', 'phone': '65 50 77 71', 'phoneExt': '+45'}], 'facility': 'National Institute of Public Health (NIPH), University of Southern Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Sofie H Hoffmann', 'role': 'CONTACT', 'email': 'sohh@sdu.dk', 'phone': '65 50 77 34', 'phoneExt': '+45'}, {'name': 'Lau C Thygesen', 'role': 'CONTACT', 'email': 'lct@sdu.dk', 'phone': '65 50 77 71', 'phoneExt': '+45'}], 'overallOfficials': [{'name': 'Anna P Folker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Public Health, University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Before end of data collection', 'ipdSharing': 'YES', 'description': 'It will be possible to share IPD, but no plans of this have yet been made.', 'accessCriteria': 'Will be published in open repositories'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}, {'name': 'Danske Regioner', 'class': 'OTHER'}, {'name': 'Jascha Fonden', 'class': 'OTHER'}, {'name': 'Region of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research, Professor, ph.d.', 'investigatorFullName': 'Anna Paldam Folker', 'investigatorAffiliation': 'University of Southern Denmark'}}}}