protocolSection identificationModule nctId: NCT06385457, orgStudyIdInfo id: 24-2933, briefTitle: The Effects of Mindhelper on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, collaborators name: TrygFonden, Denmark, collaborators name: Danske Regioner, collaborators name: Jascha Fonden, collaborators name: Centre for Digital Psychiatry, Mental Health Services in the Region of Southern Denmark, descriptionModule briefSummary: In this study the investigators will evaluate the effectiveness of Mindhelper.dk, which is the most comprehensive online youth mental health promotion service in Denmark.A minimum of 9,426 young people aged 15 to 25 will be recruited through social media and invited to participate in the study. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group. The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization.The investigators expect a small, positive effect on participants well-being and psychological functioning in intervention groups as compared to the control group., conditionsModule conditions: Mental Health Issue, conditions: Well-Being, conditions: Adolescents, conditions: Young Adults, conditions: Online Intervention, conditions: Internet-Based Intervention, conditions: Randomized Controlled Trial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study.Young people will be recruited through social medias. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group.The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: The participants are partly masked. The control group will be masked; however, the intervention group will not be masked.There is no care provider nor outcome assessor as all measures are self-reported and collected through online questionnaires.Analyses of data and interpretation of results will be done masked., whoMasked: INVESTIGATOR, enrollmentInfo count: 9426, type: ESTIMATED, armsInterventionsModule interventions name: Mindhelper- A national youth mental health promotion website, outcomesModule primaryOutcomes measure: General well-being measure by "The Well-Being Index WHO-5" (WHO5), secondaryOutcomes measure: Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS)., secondaryOutcomes measure: Intentions to help-seeking, otherOutcomes measure: Body Appreciation measured by the "2-items Short forms of the Body Appreciation Scale-2" (2-item BAS-2SF)., eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: National Institute of Public Health (NIPH), University of Southern Denmark, city: Copenhagen, state: Copenhagen K, zip: 1455, country: Denmark, contacts name: Sofie H Hoffmann, role: CONTACT, phone: 65 50 77 34, phoneExt: +45, email: sohh@sdu.dk, contacts name: Lau C Thygesen, role: CONTACT, phone: 65 50 77 71, phoneExt: +45, email: lct@sdu.dk, geoPoint lat: 55.67594, lon: 12.56553, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-04-22, uploadDate: 2024-04-22T08:21, filename: SAP_000.pdf, size: 353976, hasResults: False