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-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 tri...

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Main Authors: 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
Format: Article
Language:English
Published: BMJ Publishing Group 2023-04-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/4/e066249.full
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author 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
author_facet 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
author_sort Helen Christensen
collection DOAJ
description 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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spelling doaj.art-d5b80219f5984c87a1e4847e1d54336b2023-04-29T02:30:05ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2022-066249Protocol 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 studyHelen Christensen0Svetha Venkatesh1Aliza Werner-Seidler2Thomas Quinn3Wu Yi Zheng4Jill M Newby5Simon Rosenbaum6Andrew Mackinnon7Bonny Parkinson8Jin Han9Stuart Cameron10Kit Huckvale11Henry Cutler12Sunil Gupta13Joanne R Beames14Jodie Rosenberg15Truyen Tran16Santu Rana17Leonard Hoon18Eileen Stech19Rajesh Vasa20Scott Barnett21Manisha Senadeera22Stefanus Kurniawan23Akash Agarwal24Joost Funke Kupper25Joshua Asbury26David Willie27Alasdair Grant28Antonio Ahumada-Canale29Rena Logothetis30Marya Bautista31Artur Shvetcov32Kon Mouzakis33Alexis Whitton34School of Medicine, UNSW, Sydney, New South Wales, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia1 Black Dog Institute, University of New South Wales, Sydney, NSW, Australia4National Institute of Allergy and Infectious Diseases, Division of Intramural Research, Baltimore, USABlack Dog Institute, Sydney, New South Wales, AustraliaBlack Dog Institute, Randwick, New South Wales, AustraliaSchool of Psychiatry, UNSW, Sydney, New South Wales, Australia6 School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, AustraliaMacquarie University Centre for the Health Economy, Macquarie University, Sydney, New South Wales, AustraliaBlack Dog Institute, UNSW Sydney, Sydney, New South Wales, AustraliaApplied Artificial Intelligence Institute, Deakin University, Burwood, Victoria, AustraliaBlack Dog Institute, UNSW Sydney, Randwick, New South Wales, AustraliaCentre for the Health Economy, Macquarie University, Macquarie Park, New South Wales, Australia1 Department of Gastroenterology and Hepatology, Westmead Hospital, Westmead, New South Wales, AustraliaBlack Dog Institute, University of New South Wales, Sydney, New South Wales, AustraliaBlack Dog Institute, UNSW Sydney, Sydney, New South Wales, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, Australia1Centre for Pattern Recognition and Data Analytics, School of Information Technology, Deakin University, Geelong, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaBlack Dog Institute, UNSW Sydney, Sydney, New South Wales, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaCentre for the Health Economy, Macquarie University, Sydney, New South Wales, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaBlack Dog Institute, UNSW Sydney, Sydney, New South Wales, AustraliaBlack Dog Institute, UNSW Sydney, Sydney, New South Wales, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaBlack Dog Institute, UNSW Sydney, Sydney, New South Wales, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/13/4/e066249.full
spellingShingle 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
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
BMJ Open
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/13/4/e066249.full
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