Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 15, 2025
Date Accepted: Apr 22, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Mental health INtervention with Digital APPlications (MIND-APP): Protocol for a Randomized Controlled Researcher Blinded Trial Evaluating the Effectiveness of the Tankevirus and Grubl Mental Health Apps Compared to a Placebo App: A Stage 1 Registered Report
ABSTRACT
Background:
Anxiety and depression impose substantial clinical and economic burdens worldwide, with high prevalence, impaired functioning, and elevated health care costs. Digital self-help interventions offer scalable and potentially cost-effective strategies, yet evidence from rigorously controlled economic evaluations remains sparse.
Objective:
This trial aims to evaluate the effectiveness and cost-effectiveness of two Norwegian mental health apps—Tankevirus (cognitive behavioural therapy-based) and Grubl (metacognitive therapy-based)—compared to a digital placebo in reducing anxiety and depression symptoms, improving health-related quality of life, and generating quality-adjusted life years (QALYs).
Methods:
The MIND-APP trial is a three-arm randomized controlled trial (1:1:1 allocation) conducted fully remotely via a bespoke smartphone research platform. A total of 1,000 Norwegian residents aged ≥16 years with mild to moderate anxiety and/or depression will be recruited through national digital outreach. Co-primary outcomes are changes in anxiety (GAD-7) and depression (PHQ-9) scores from baseline to post-intervention (4 weeks). Secondary outcomes include health-related quality of life (EQ-5D-5L), QALYs accrued over 6 months, functional impairment (WSAS), health care resource use, and adverse events. Incremental cost-effectiveness ratios (ICERs) for Tankevirus and Grubl relative to placebo will be estimated from the perspective of public health services.
Results:
Funding was secured in April 2025, with ethical approvals, licensing, and app development planned through 2026. Recruitment will commence in late 2026 with follow-up through 2027. Results will provide robust evidence on the clinical and economic value of scalable app-based interventions for common mental health disorders.
Conclusions:
This trial will be among the first large-scale registered reports to combine rigorous clinical and economic evaluation of digital mental health interventions. Findings will inform health policy and resource allocation by determining whether low-cost, app-based programs represent cost-effective solutions for reducing the burden of anxiety and depression. Clinical Trial: To be registered at DRKS (primary registration) and ClinicalTrials.gov for visibility.
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Copyright
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