Efficacy of the “Foundations” smartphone application in improving mental well-being in students:a randomized controlled trial

The mental health challenges faced by student populations is a growing global public health issue. Accessible, scalable, and effective interventions are urgently needed. The primary objective of this study was to determine the efficacy of Foundations (Koa Health; Barcelona, Spain), a digital mental health intervention, compared to a waitlist control group in university students. We hypothesized that participants in the Foundations group would show greater improvement in well-being scores compared to those in the control group, after 2 and 4 weeks of usage. As part of a larger study, 232 participants were included in the primary analyses (Foundations, n = 95; control, n = 137). Well-being scores improved in both groups; however, improvements in well-being were significantly greater in the Foundations group after 4 weeks. Taken together, the present findings support the efficacy of digital mental health tools like Foundations in a student population. Trial Registration: OSF Registration, Registration https://doi.org/10.17605/OSF.IO/HVTF8 ; https://osf.io/hvtf8.