Protocol for a bandit-based response adaptive trial to evaluate the effectiveness of brief self-guided digital interventions for reducing psychological distress in university students: The Vibe Up Study.

Introduction: Meta-analytic evidence confirms a range of in- terventions, including mindfulness, physical activity and sleep hygiene, can reduce psychological distress in university stu- dents. However, it is unclear which intervention is most ef- fective. Artificial intelligence (AI) driven adaptive trials may be an efficient method to determine what works best and for whom. The primary purpose of the study is to rank the effec- tiveness of mindfulness, physical activity, sleep hygiene and an active control on reducing distress, using a multi-arm con- textual bandit-based AI-adaptive trial method. Furthermore, the study will explore which interventions have the largest ef- fect for students with different levels of baseline distress sever- ity. Methods and analysis: The Vibe Up study is a pragmatically-oriented, decentralised AI-adaptive group se- quential randomised controlled trial (RCT) comparing the ef- fectiveness of one of three brief, two week digital self-guided interventions (mindfulness, physical activity, or sleep hygiene) or active control (ecological momentary assessment) in reduc- ing self-reported psychological distress in Australian univer- sity students. The adaptive trial methodology involves up to 12 sequential mini-trials that allow for the optimisation of al- location ratios. The primary outcome is change in psycho- logical distress (DASS-21 total score) from pre-intervention to post-intervention. Secondary outcomes include change in depression, anxiety, and stress (measured by DASS-21 sub- scales) from pre-intervention to post-intervention. Planned contrasts will compare the four groups (i.e., the three interven- tion and control) using self-reported psychological distress at pre-specified time points for interim analyses. The study aims to determine the best performing intervention, as well as rank- ing of other interventions. Ethics and dissemination: Ethical approval was sought and obtained from the UNSW Sydney Human Research Ethics Committee (HREC A, HC200466). A trial protocol adhering to the requirements of the Guideline for Good Clinical Prac- tice [1] was prepared for and approved by the Sponsor, UNSW Sydney (Protocol number: HC200466_CTP). Registration details: The trial is registered with the Australian New Zealand Clinical Trials Registry (AC- TRN12621001223820).