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
Helen Christensen,
Svetha Venkatesh,
Aliza Werner-Seidler,
Thomas Quinn,
Wu Yi Zheng,
Jill M Newby,
Simon Rosenbaum,
Andrew Mackinnon,
Bonny Parkinson,
Jin Han,
Stuart Cameron,
Kit Huckvale,
Henry Cutler,
Sunil Gupta,
Joanne R Beames,
Jodie Rosenberg,
Truyen Tran,
Santu Rana,
Leonard Hoon,
Eileen Stech,
Rajesh Vasa,
Scott Barnett,
Manisha Senadeera,
Stefanus Kurniawan,
Akash Agarwal,
Joost Funke Kupper,
Joshua Asbury,
David Willie,
Alasdair Grant,
Antonio Ahumada-Canale,
Rena Logothetis,
Marya Bautista,
Artur Shvetcov,
Kon Mouzakis,
Alexis Whitton
Affiliations
Helen Christensen
Black Dog Institute, University of New South Wales, Sydneyali, New South Wales, Australia
Svetha Venkatesh
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Aliza Werner-Seidler
2 Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia
Thomas Quinn
Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Wu Yi Zheng
Black Dog Institute, UNSW Sydney, Sydney, New South Wales, Australia
Jill M Newby
Black Dog Institute, UNSW Sydney, Sydney, New South Wales, Australia
Simon Rosenbaum
School of Psychiatry, UNSW Sydney, Sydney, New South Wales, Australia
Andrew Mackinnon
1 Black Dog Institute, Sydney, New South Wales, Australia
Bonny Parkinson
Centre for the Health Economy, Macquarie University, Sydney, New South Wales, Australia
Jin Han
1 Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia
Stuart Cameron
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Kit Huckvale
Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia
Henry Cutler
Centre for the Health Economy, Macquarie University, Sydney, New South Wales, Australia
Sunil Gupta
Department of Gastroenterology and Hepatology, Westmead Hospital, Westmead, New South Wales, Australia
Joanne R Beames
Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia
Jodie Rosenberg
Black Dog Institute, UNSW Sydney, Sydney, New South Wales, Australia
Truyen Tran
3Centre for Pattern Recognition and Data Analytics, Deakin University, Australia, Geelong, Victoria, Australia
Santu Rana
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Leonard Hoon
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Eileen Stech
Black Dog Institute, UNSW Sydney, Sydney, New South Wales, Australia
Rajesh Vasa
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Scott Barnett
8 Applied Artificial Intelligence Institute, Deakin University, Geelong, Victoria, Australia
Manisha Senadeera
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Stefanus Kurniawan
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Akash Agarwal
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Joost Funke Kupper
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Joshua Asbury
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
David Willie
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Alasdair Grant
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Antonio Ahumada-Canale
Centre for the Health Economy, Macquarie University, Sydney, New South Wales, Australia
Rena Logothetis
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Marya Bautista
Black Dog Institute, UNSW Sydney, Sydney, New South Wales, Australia
Artur Shvetcov
Black Dog Institute, UNSW Sydney, Sydney, New South Wales, Australia
Kon Mouzakis
Applied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia
Alexis Whitton
Black Dog Institute, UNSW Sydney, Sydney, New South Wales, Australia
Introduction Meta-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 analysis The 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 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 Practice was prepared for and approved by the Sponsor, UNSW Sydney (Protocol number: HC200466_CTP).Trial registration number ACTRN12621001223820.
