Efficacy of a digital mental health program for university students: A randomized controlled trial comparing online...

University students are a high-risk population for mental health problems. However they often face barriers to care. Digital Mental Health Interventions are scalable tools to support well-being, yet evidence regarding optimal delivery formats remains mixed. This study assessed the efficacy of ETUCARE, an 8-week multicomponent digital program comparing online-only and hybrid (online + in-person workshops) delivery formats.A three-arm randomized controlled trial was conducted among 1064 French university students assigned to an online-only (n = 460), a hybrid (n = 235), or a waitlist control group (n = 369). Self-report measures were collected at baseline (T1), post-intervention (T2), and 8-week follow-up (T3). Outcomes included psychological distress, well-being, emotion regulation, insomnia, and alcohol use. Linear mixed-effects models examined time × group effects. Clinical transitions were analyzed using multinomial logistic regressions and chi-square tests.Significant time × group interactions indicated more favorable change trajectories for psychological distress, emotion regulation, insomnia, and several well-being dimensions in both intervention groups than in the waitlist control group. No consistent differences were observed between delivery formats on global outcomes, and no differential intervention effect was found for alcohol use. Sensitivity analyses showed that program completion contributed additively to some outcomes without accounting for group-related differences. Exploratory clinical transition analyses suggested an increased likelihood of remission for psychological distress and insomnia in both intervention groups, with greater symptom improvement in the hybrid format among students with higher baseline severity, and a possible protective effect of the online-only format against symptom aggravation at post-test, an effect not maintained at follow-up.ETUCARE showed small benefits over the waitlist condition for psychological distress, insomnia, emotion regulation, and selected dimensions of psychological well-being. The broadly comparable outcomes of the two delivery formats suggest that the online-only format may provide a more scalable option for universal student mental health promotion.

This trial was not prospectively registered.

The study was approved by the Ethics Committee of Nantes University (IRB No. IORG0011023, Ref. 06042023-2). All participants provided informed consent before enrolment.