Efficacy of the Digital Therapeutic Mobile App "BioBase" to Reduce Stress and Improve Mental Wellbeing Among University Students: a Randomized Controlled Trial.

This is the author accepted manuscript. The final version is available from JMIR Publications via the DOI in this record.BACKGROUND: UK university students are experiencing increasing levels of anxiety. A programme designed to increase awareness of one's present levels of wellbeing and suggest personalized health behaviours may reduce anxiety and improve mental wellbeing in students. The efficacy of a digital version of such a programme, providing biofeedback and therapeutic content based on personalized wellbeing metrics, is reported here. OBJECTIVE: The aim of this study was to test the efficacy and sustained effects of using a mobile app (BioBase) and paired wearable device (BioBeam), compared to a wait-list control group, on anxiety and wellbeing in university students with elevated levels of anxiety and stress. METHODS: The study employed a randomized, wait-list controlled, trial with assessments at baseline, 2-weeks, post-intervention (4 weeks), and at follow-up (6 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored >14 points on the DASS-21 stress subscale or > 7 points on the DASS-21 anxiety subscale, (3) owned an iOS smartphone, (4) did not have any previous psychiatric or neurological conditions, (6) were not pregnant at the time of testing, and (7) were able to read and understand English. Participants were encouraged to use BioBase daily and complete at least one course of therapeutic content. A p value ≤.05 was considered statistically significant. RESULTS: We found that a 4-weeks intervention with the BioBase programme significantly reduced anxiety and increased perceived wellbeing, with sustained effects at a 2-weeks follow-up. Furthermore, a significant reduction in depression levels was found following 4-weeks usage of Biobase. CONCLUSIONS: This study shows the efficacy of a biofeedback digital intervention in reducing self-reported anxiety and increasing perceived wellbeing in UK university students. Results suggest that digital mental health interventions could constitute a novel approach to treat stress and anxiety in students, which could be combined, or integrated with, existing therapeutic pathways. CLINICALTRIAL: https://osf.io/2w5sy/