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

Abstract

IntroductionMeta-analytical evidence confirms a range of interventions, including mindfulness, physical activity and sleep hygiene, can reduce psychological distress in university students. However, it is unclear which intervention is most effective. 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 effectiveness of mindfulness, physical activity, sleep hygiene and an active control on reducing distress, using a multiarm contextual bandit-based AI-adaptive trial method. Furthermore, the study will explore which interventions have the largest effect for students with different levels of baseline distress severity.Methods and analysisThe Vibe Up study is a pragmatically oriented, decentralised AI-adaptive group sequential randomised controlled trial comparing the effectiveness of one of three brief, 2-week digital self-guided interventions (mindfulness, physical activity or sleep hygiene) or active control (ecological momentary assessment) in reducing self-reported psychological distress in Australian university students. The adaptive trial methodology involves up to 12 sequential mini-trials that allow for the optimisation of allocation ratios. The primary outcome is change in psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score) from preintervention to postintervention. Secondary outcomes include change in physical activity, sleep quality and mindfulness from preintervention to postintervention. Planned contrasts will compare the four groups (ie, the three intervention and control) using self-reported psychological distress at prespecified time points for interim analyses. The study aims to determine the best performing intervention, as well as ranking of other interventions.Ethics and disseminationEthical 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 Practice was prepared for and approved by the Sponsor, UNSW Sydney (Protocol number: HC200466_CTP).Trial registration numberACTRN12621001223820.

Artificial Intelligence and Mindfulness: Systematic Literature Review Based on Prisma Method

“…According to Huckvale et al (2023), compared to standard RCTs, the AI-driven adaptive trial technique is a more effective way of assessing the efficacy of therapies. An economic analysis using a value of information (VoI) analysis will be part of the study to determine if the AI-adaptive trial design is more valuable than a normal four-arm RCT.…”

“…Also, according to Huckvale et al (2023), fewer individuals are increasingly assigned to therapies with diminishing efficacy in subsequent mini-trials. In adaptive trials powered by artificial intelligence (AI), they conduct a series of "mini-trials" in which the outcomes of one inform the next.…”

“…AI-driven adaptive trials promise to provide a faster and more efficient alternative to randomised controlled trials (RCTs), particularly when there are numerous potentially effective choices, and it is crucial to discover which treatment option is optimal for a certain population (Huckvale et al, 2023).…”

“…So, the economic evaluation will look at how the uncertainty of decisions changes when using the AI-adaptive trial method versus a standard four-arm RCT method. (Huckvale et al, 2023) Young people may also prefer to obtain mental health assistance via websites and applications despite the efforts of health care practitioners. (Zhou et al, 2021)…”

“…As Huckvale et al (2023) stressed, mindfulness is "the awareness that arises from paying attention on purpose, in the present moment, and without judgment to the unfolding of experience in the present moment". Mindfulness meditation can be instructor-led or self-directed (e.g., learning mindfulness techniques utilising a series of guided audio meditations).…”