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.

Huckvale, K; Hoon, L; Stech, E; Newby, JM; Zheng, WY; Han, J; Vasa, R; Gupta, S; Barnett, S; Senadeera, M; Cameron, S; Kurniawan, S; Agarwal, A; Kupper, JF; Asbury, J; Willie, D; Grant, A; Cutler, H; Parkinson, B; Ahumada-Canale, A; Beames, JR; Logothetis, R; Bautista, M; Rosenberg, J; Shvetcov, A; Quinn, T; Mackinnon, A; Rana, S; Tran, T; Rosenbaum, S; Mouzakis, K; Werner-Seidler, A; Whitton, A; Venkatesh, S; Christensen, H

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.

Huckvale, K Hoon, L Stech, E Newby, JM Zheng, WY Han, J Vasa, R Gupta, S Barnett, S Senadeera, M Cameron, S Kurniawan, S Agarwal, A Kupper, JF Asbury, J Willie, D Grant, A Cutler, H Parkinson, B Ahumada-Canale, A Beames, JR Logothetis, R Bautista, M Rosenberg, J Shvetcov, A Quinn, T Mackinnon, A Rana, S Tran, T Rosenbaum, S Mouzakis, K Werner-Seidler, A Whitton, A Venkatesh, S Christensen, H

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Publisher:: BMJ PUBLISHING GROUP
Publication Type:: Journal Article
Citation:: BMJ Open, 2023, 13, (4), pp. e066249
Issue Date:: 2023-04-28

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Field	Value	Language
dc.contributor.author	Huckvale, K
dc.contributor.author	Hoon, L
dc.contributor.author	Stech, E
dc.contributor.author	Newby, JM
dc.contributor.author	Zheng, WY
dc.contributor.author	Han, J
dc.contributor.author	Vasa, R
dc.contributor.author	Gupta, S
dc.contributor.author	Barnett, S
dc.contributor.author	Senadeera, M
dc.contributor.author	Cameron, S
dc.contributor.author	Kurniawan, S
dc.contributor.author	Agarwal, A
dc.contributor.author	Kupper, JF
dc.contributor.author	Asbury, J
dc.contributor.author	Willie, D
dc.contributor.author	Grant, A
dc.contributor.author	Cutler, H
dc.contributor.author	Parkinson, B
dc.contributor.author	Ahumada-Canale, A
dc.contributor.author	Beames, JR
dc.contributor.author	Logothetis, R
dc.contributor.author	Bautista, M
dc.contributor.author	Rosenberg, J
dc.contributor.author	Shvetcov, A
dc.contributor.author	Quinn, T
dc.contributor.author	Mackinnon, A
dc.contributor.author	Rana, S
dc.contributor.author	Tran, T
dc.contributor.author	Rosenbaum, S
dc.contributor.author	Mouzakis, K
dc.contributor.author	Werner-Seidler, A
dc.contributor.author	Whitton, A
dc.contributor.author	Venkatesh, S
dc.contributor.author	Christensen, H
dc.date.accessioned	2023-11-08T05:15:16Z
dc.date.available	2023-11-08T05:15:16Z
dc.date.issued	2023-04-28
dc.identifier.citation	BMJ Open, 2023, 13, (4), pp. e066249
dc.identifier.issn	2044-6055
dc.identifier.issn	2044-6055
dc.identifier.uri	http://hdl.handle.net/10453/173245
dc.description.abstract	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.
dc.format	Electronic
dc.language	eng
dc.publisher	BMJ PUBLISHING GROUP
dc.relation.ispartof	BMJ Open
dc.relation.isbasedon	10.1136/bmjopen-2022-066249
dc.rights	info:eu-repo/semantics/restrictedAccess
dc.rights	© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ
dc.subject	1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
dc.subject.classification	32 Biomedical and clinical sciences
dc.subject.classification	42 Health sciences
dc.subject.classification	52 Psychology
dc.subject.mesh	Humans
dc.subject.mesh	Universities
dc.subject.mesh	Artificial Intelligence
dc.subject.mesh	Australia
dc.subject.mesh	Mindfulness
dc.subject.mesh	Psychological Distress
dc.subject.mesh	Students
dc.subject.mesh	Stress, Psychological
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Humans
dc.subject.mesh	Stress, Psychological
dc.subject.mesh	Students
dc.subject.mesh	Universities
dc.subject.mesh	Artificial Intelligence
dc.subject.mesh	Australia
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Mindfulness
dc.subject.mesh	Psychological Distress
dc.subject.mesh	Humans
dc.subject.mesh	Universities
dc.subject.mesh	Artificial Intelligence
dc.subject.mesh	Australia
dc.subject.mesh	Mindfulness
dc.subject.mesh	Psychological Distress
dc.subject.mesh	Students
dc.subject.mesh	Stress, Psychological
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.title	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.
dc.type	Journal Article
utslib.citation.volume	13
utslib.location.activity	England
utslib.for	1103 Clinical Sciences
utslib.for	1117 Public Health and Health Services
utslib.for	1199 Other Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Business
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Centre for Health Economics Research and Evaluation
utslib.copyright.status	open_access	*
dc.date.updated	2023-11-08T05:15:15Z
pubs.issue	4
pubs.publication-status	Published online
pubs.volume	13
utslib.citation.issue	4

Abstract:

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.

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