Clinical Trial

The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People

Completed
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 changes
critical Trial completed 2026-07-24
notable Enrollment reduced: 4910 -> 4355 participants 2026-07-24
Trial Details
NCT Number NCT06385457
Lead Sponsor University of Southern Denmark
Collaborators: TrygFonden, Denmark, Danske Regioner, Jascha Fonden, Region of Southern Denmark
Conditions Mental Health Issue, Well-Being, Adolescents, Young Adults, Online Intervention, Internet-Based Intervention, Randomized Controlled Trial, Body Dissatisfaction
Enrollment 4,355 participants
Start Date 2025-01-07
Primary Completion 2026-05-20 (estimated)
Study Completion 2026-05-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-23