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BACKGROUND There has been a surge in mental health concerns during the pandemic, which has prompted increased use of digital platforms. However, there is little known about the mental health needs and behaviors of the global population during the pandemic. This study aims to answer these questions through the analysis of real world data collected from users of a digital mental health app (Wysa) around their engagement patterns and behaviors as shown by their usage of the service. OBJECTIVE This study aimed: (1) To examine the relationship between mental health distress, digital health uptake and COVID-19 case numbers (2) to evaluate engagement patterns with the app during the study period (3) to examine the efficacy of the app in improving mental health outcomes for its users during the pandemic. METHODS The study used a retrospective observational design. During COVID-19, the app’s installations and emotional utterances were measured during March 2020 to October 2021, for the United Kingdom, United States of America and India and mapped against COVID-19 case numbers and their peaks. The engagement of the users in this period (N= 4541) with the Wysa app was compared to equivalent samples of users from a pre-COVID-19 period (1000 iterations). The efficacy was assessed for users who completed pre-post assessments for symptoms of depression (N=2061) and anxiety (N= 1995) on PHQ-9 and GAD-7 test measures. RESULTS Findings demonstrate a significant positive correlation between the increase in installs of mental health app Wysa and the peaks of COVID-19 case numbers in UK (P=.018) and India (P=.0001). Findings indicate that users during the COVID period had a significantly higher degree of engagement than the pre-COVID period, with a medium to large effect size for 80% of these samples observed on the Mann-Whitney test. The PHQ-9 and GAD-7 pre-post assessments indicated statistically significant improvement with medium effect size (P= 0.569 for PHQ-9 and P=0.562 for GAD-7). CONCLUSIONS This study demonstrated that emotional distress increased substantially during the pandemic prompting increased uptake of an AI led mental health app Wysa, and also offered evidence that the app Wysa could support its users and lead to a significant reduction in symptoms of anxiety and depression. The study also highlights the importance of contextualizing interventions and suggests that digital health interventions can provide large populations with scalable and evidence-based support for mental health care. CLINICALTRIAL
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