Abstract

BackgroundThe effect of an unguided internet-based cognitive behavioral therapy (iCBT) stress management program on depression may be enhanced by applying artificial intelligence (AI) technologies to guide participants adopting the program.ObjectiveThe aim of this study is to describe a research protocol to investigate the effect of a newly developed iCBT stress management program adopting AI technologies on improving depression among healthy workers during the COVID-19 pandemic.MethodsThis study is a two-arm, parallel, randomized controlled trial. Participants (N=1400) will be recruited, and those who meet the inclusion criteria will be randomly allocated to the intervention or control (treatment as usual) group. A 6-week, six-module, internet-based stress management program, SMART-CBT, has been developed that includes machine-guided exercises to help participants acquire CBT skills, and it applies machine learning and deep learning technologies. The intervention group will participate in the program for 10 weeks. The primary outcome, depression, will be measured using the Beck Depression Inventory II at baseline and 3- and 6-month follow-ups. A mixed model repeated measures analysis will be used to test the intervention effect (group × time interactions) in the total sample (universal prevention) on an intention-to-treat basis.ResultsThe study was at the stage of recruitment of participants at the time of submission. The data analysis related to the primary outcome will start in January 2022, and the results might be published in 2022 or 2023.ConclusionsThis is the first study to investigate the effectiveness of a fully automated machine-guided iCBT program for improving subthreshold depression among workers using a randomized controlled trial design. The study will explore the potential of a machine-guided stress management program that can be disseminated online to a large number of workers with minimal cost in the post–COVID-19 era.Trial RegistrationUMIN Clinical Trials Registry(UMIN-CTR) UMIN000043897; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050125International Registered Report Identifier (IRRID)PRR1-10.2196/30305

Highlights

  • BackgroundBoth depressive disorders and subthreshold symptoms of depression are major public health problems because of the high prevalence of depression and its substantial impacts in terms of distress, disability, and impaired quality of life [1,2]

  • The study will explore the potential of a machine-guided stress management program that can be disseminated online to a large number of workers with minimal cost in the post–COVID-19 era

  • Internet-based online stress management programs that incorporate cognitive behavioral therapy (CBT) have been shown to be effective in reducing symptoms of depression and the risk of major depressive disorder among symptomatic groups [5,6], and in the general [7] and working population [8]. Such internet-based CBT programs are easy for people to access and can be delivered to a large number of people at a relatively low cost compared to face-to-face or group-based CBT programs

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Summary

Introduction

BackgroundBoth depressive disorders and subthreshold symptoms of depression are major public health problems because of the high prevalence of depression and its substantial impacts in terms of distress, disability, and impaired quality of life [1,2]. Internet-based (or web-based) online stress management programs that incorporate cognitive behavioral therapy (CBT) have been shown to be effective in reducing symptoms of depression and the risk of major depressive disorder among symptomatic groups [5,6], and in the general [7] and working population [8]. Such internet-based CBT (iCBT) programs are easy for people to access and can be delivered to a large number of people at a relatively low cost compared to face-to-face or group-based CBT programs. The effect of an unguided internet-based cognitive behavioral therapy (iCBT) stress management program on depression may be enhanced by applying artificial intelligence (AI) technologies to guide participants adopting the program

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