JMIR Res Protoc. 2025 Sep 10;14:e73736. doi: 10.2196/73736.
ABSTRACT
BACKGROUND: The high and increasing rate of poor mental health among young people is a matter of global concern. Experiencing poor mental health during this formative stage of life can adversely impact interpersonal relationships, academic and professional performance, and future health and well-being if not addressed early. However, only a few of those in need seek help. Research indicates that young people perceive digital mental health support as having many benefits compared to traditional face-to-face services. However, the effectiveness of self-guided digital mental health services is not well documented, and research on their cost-effectiveness is lacking. Mindhelper is Denmark’s largest open access, digital, self-guided mental health service for young people. While it does not provide direct psychological or therapeutic care, it offers practical strategies and tools to promote well-being and address a broad spectrum of mental health challenges, from everyday stress to more complex issues. Despite its widespread use, the effectiveness of Mindhelper has not been evaluated.
OBJECTIVE: This trial aims to evaluate the effectiveness of building on the results of our feasibility study. We will assess Mindhelper’s impact on mental health and well-being, psychological functioning, intentions of help seeking, and body appreciation among people aged between 15 and 25 years and provide insights into the service’s cost-effectiveness.
METHODS: We will recruit 4910 people aged between 15 and 25 years via social media and randomized and allocated to an intervention group (receiving information about Mindhelper) or a control group (no information about Mindhelper). Outcomes are self-assessed and collected at baseline and 2, 6, and 12 weeks after randomization through online surveys 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.
RESULTS: This study was fully funded in November 2022, and the data collection started in January 2025. As of August 2025, we enrolled 2613 people. The data analysis will start after data collection concludes (by early 2026), and the results of the primary outcome are expected to be published in the second half of 2026.
CONCLUSIONS: This study will deliver crucial evidence on the effectiveness of self-guided digital mental health promotion targeting young people. If effective, this highly scalable service may contribute to combating the trend of rising mental health issues among young people and address key challenges in primary care by delivering timely, coordinated, and effective services to young individuals, potentially at a low cost.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06385457; https://clinicaltrials.gov/ct2/show/NCT06385457.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/73736.
PMID:40929726 | DOI:10.2196/73736
