ABSTRACT
BACKGROUND: The prolonged COVID-19 pandemic has affected mental health among workers. Psychoeducational intervention via a website could be effective for primary prevention of mental illness among workers in the current COVID-19 pandemic. OBJECTIVE: The aim of this randomized controlled trial is to examine the effect of a newly developed online psychoeducational website named Imacoco Care on reducing psychological distress and fear about COVID-19 infection among workers. METHODS: Participants in the study were recruited from registered members of a web survey company in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to the intervention or control group. Participants in the intervention group were invited to access the Imacoco Care program within a month after the baseline survey. The Kessler Psychological Distress Scale (K6) and the Fear of COVID-19 Scale (FCV-19S) scores were obtained at baseline and at 1- and 3-month follow-ups. RESULTS: A total of 1200 workers were randomly allocated to the intervention and control groups (n=600 [50%] per group). The Imacoco Care intervention group showed a significant favorable effect on K6 scores (P=.03) with a small effect size (ES; Cohen d=-0.14) and an adverse effect on FCV-19S scores (P=.01) with a small ES (Cohen d=0.16) at 3-month follow-up. In the per protocol analysis (including only participants who had read the Imacoco Care content at least 1 time), the Imacoco Care intervention group also showed a significant favorable effect on reducing K6 scores (P=.03), while an adverse effect on FCV-19S scores was not significant (P=.06) in the intervention group at 3-month follow-up. CONCLUSIONS: A web-based psychoeducation approach may be effective for improving psychological distress among workers; however, it may be important not only to distribute information but also to encourage active engagement with the content of the program to prevent adverse effects of psychoeducational intervention. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042556; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548.
ABSTRACT
BACKGROUND: 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. OBJECTIVE: The 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. METHODS: This 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. RESULTS: The 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. CONCLUSIONS: This 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 REGISTRATION: UMIN Clinical Trials Registryï¼UMIN-CTR) UMIN000043897; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050125. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/30305.