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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
January 1, 1970
Kit Huckvale et al. (35 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to rank the effectiveness of mindfulness compared to physical activity, sleep hygiene, and an active control in reducing psychological distress in university students using an AI-adaptive trial method.

Results Summary

The study compared mindfulness, physical activity, sleep hygiene, and an active control, measuring changes in psychological distress (DASS-21 scores). While the abstract does not specify individual intervention results, the adaptive trial design aimed to determine the best-performing intervention and rank their effectiveness.

Population

Australian university students

Effective Dosage

Not specified

Duration

2 weeks

Interactions

None mentioned

Extracted Claims (23)
InterventionDirectionEndpointPopulationDosageImpactClaim #
mindfulness
decrease
psychological distress
university students
-
can reduce
#1
physical activity
decrease
psychological distress
university students
-
can reduce
#2
sleep hygiene
decrease
psychological distress
university students
-
can reduce
#3
mindfulness
decrease
self-reported psychological distress
Australian university students
-
reducing
#4
physical activity
decrease
self-reported psychological distress
Australian university students
-
reducing
#5
sleep hygiene
decrease
self-reported psychological distress
Australian university students
-
reducing
#6
ecological momentary assessment
decrease
self-reported psychological distress
Australian university students
-
reducing
#7
mindfulness
decrease
psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score)
Australian university students
-
change in
#8
physical activity
decrease
psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score)
Australian university students
-
change in
#9
sleep hygiene
decrease
psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score)
Australian university students
-
change in
#10
ecological momentary assessment
decrease
psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score)
Australian university students
-
change in
#11
mindfulness
neutral
physical activity
Australian university students
-
change in
#12
physical activity
neutral
physical activity
Australian university students
-
change in
#13
sleep hygiene
neutral
physical activity
Australian university students
-
change in
#14
ecological momentary assessment
neutral
physical activity
Australian university students
-
change in
#15
mindfulness
neutral
sleep quality
Australian university students
-
change in
#16
physical activity
neutral
sleep quality
Australian university students
-
change in
#17
sleep hygiene
neutral
sleep quality
Australian university students
-
change in
#18
ecological momentary assessment
neutral
sleep quality
Australian university students
-
change in
#19
mindfulness
neutral
mindfulness
Australian university students
-
change in
#20
physical activity
neutral
mindfulness
Australian university students
-
change in
#21
sleep hygiene
neutral
mindfulness
Australian university students
-
change in
#22
ecological momentary assessment
neutral
mindfulness
Australian university students
-
change in
#23
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.

Medical Subject Headings (MeSH)
HumansUniversitiesArtificial IntelligenceAustraliaMindfulnessPsychological DistressStudentsStress, PsychologicalRandomized Controlled Trials as TopicAdaptive Clinical Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations6
Citations/Year3.0
Relative Citation Ratio2.27
NIH Percentile78.2%
Research Impact Scores
APT Score0.50
Weight Score1.66
Normalized Score0.67
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