Health Mode On and Health Mode On Plus: a multisite protocol to assess and promote mental wellbeing and healthy lifestyles among Italian university students

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Introduction: University is a pivotal life-course transition in which academic, social and geographic changes intersect with heightened risk for mental disorders and maladaptive behaviors. Health Mode On (HMO) and its longitudinal expansion Health Mode On Plus (HMO+), funded by the Italian Ministry of University and Research (MUR) competitive PRO-BEN 1 and PRO-BEN 2 calls, couple harmonized surveillance with a stepped, integrated model of prevention and care aligned with the World Mental Health-International College Student (WMH-ICS) framework to address fragmentation of campus provision and unmet need. Methods and analysis: HMO implements a cross-sectional, census-style online survey paired with the implementation of an integrated counseling pathway and a Virtual Academy for staff and student mentors. HMO+ adds 12-month re-contact, objective lifestyle sub-studies, and a strengthened shared digital platform that supports first-contact intake, triage, and orientation to the most appropriate service. Within this framework, students with an anxiety risk profile may be offered participation in an embedded two-arm randomized evaluation of digital cognitive-behavioral therapy (e-CBT) versus counseling-as-usual. The consortium spans five universities, four higher artistic and musical education (AFAM) institutes and one Scuola Superiore Universitaria, in coordination with University Sports Centres (CUS). Primary outcomes are 12-month and lifetime DSM-5 disorder status derived from validated WMH-ICS/CIDI-based modules (mood; anxiety; trauma- and stressor-related; obsessive-compulsive and related; eating; attention-deficit/hyperactivity; and substance use disorders), and safety outcomes (suicidal ideation, planning and non-suicidal self-injury). Secondary outcomes include psychological distress, role impairment, days-out-of-role, sleep, physical activity (accelerometry in subsamples), dietary habits, nicotine and cannabis use, behavioral addictions (e.g., gaming, gambling, internet addiction), social connectedness, academic engagement and service access. Analyses will estimate weighted prevalence and impairment with multilevel models; longitudinal change with mixed-effects models and GEE; and naturalistic program effects using difference-in-differences with propensity-score methods. Ethics and dissemination: Ethics approvals will be obtained at the coordinating and partner institutions. GDPR-compliant governance and results' FAIR-oriented sharing are planned, alongside open-access publications, institutional dashboards and policy briefs.

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