The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People
NCT ID: NCT06385457
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4910 participants
INTERVENTIONAL
2025-01-06
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
According 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.
OTHER
SINGLE
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.
Study Groups
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Intervention group
The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period.
Mindhelper- A national youth mental health promotion website
Mindhelper is an open-access, digital self-directed mental health service that provides information, self-help tools and guidance to young people in Denmark.
Control group
The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.
No interventions assigned to this group
Interventions
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Mindhelper- A national youth mental health promotion website
Mindhelper is an open-access, digital self-directed mental health service that provides information, self-help tools and guidance to young people in Denmark.
Eligibility Criteria
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Inclusion Criteria
15 Years
25 Years
ALL
Yes
Sponsors
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TrygFonden, Denmark
INDUSTRY
Danske Regioner
OTHER
Jascha Fonden
OTHER
Region of Southern Denmark
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Anna Paldam Folker
Head of Research, Professor, ph.d.
Principal Investigators
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Anna P Folker
Role: PRINCIPAL_INVESTIGATOR
National Institute of Public Health, University of Southern Denmark
Locations
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National Institute of Public Health (NIPH), University of Southern Denmark
Copenhagen, Copenhagen K, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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24-2933
Identifier Type: -
Identifier Source: org_study_id
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