Mobile Interventions for the Prevention and Detection of Distress

Study Overview
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Brief Summary
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Stress, anxiety, distress and depression are exceptionally high among healthcare providers at the frontline of the COVID-19 pandemic. Knowledge of factors underlying distress and resilience and evidence based interventions to impact the mental wellbeing of frontline healthcare providers is limited. This study will evaluate a novel mobile platform to gather the distress experience of healthcare workers at Unity Health Toronto in real time during and after the COVID-19 pandemic, use automated personalized mobile interventions (e.g. routine, sleep, exercise) to nudge active/passive parameters to manage distress.

Official Title
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Could Mobile-based Interventions Aid To Understand and Flatten the Curve of Stress, Anxiety, Distress and Depression Among Healthcare Providers at Unity Health Toronto During and After the COVID-19 Pandemic?

Conditions
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Depression, Anxiety, Stress, Loneliness

Intervention / Treatment
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* Other: Mobile Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Staff or healthcare providers working at Unity Health Toronto 18 years of age or older Must own a mobile phone running Android Version 6.0 and higher, or an iPhone 6 running OS 14 and higher) Exclusion Criteria: Non-Unity Health Toronto staff

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Upon logging into the study platform, half of the participants will be automatically randomized to receive (for 4 weeks) daily-personalized automated alerts (The mobile intervention). This feature will be made available to all participants after 4 weeks. Hence, for the first 4 weeks, this study can be described as having a parallel group study model. After 4 weeks, the study switches to a single group study model, and can therefore be described as having a single group interventional model after 4 weeks from the start date until the rest of the duration of the study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Intervention Group<br>One half of the participants will receive personalized automated alerts throughout their involvement. | Other: Mobile Intervention<br>* Active mobile data will be used to provide automated, personalized notifications to frontline healthcare workers. Key information on mental health and links to access additional health resources will be available on the mobile platform.<br>|
| No Intervention: Control Group<br>For 4 weeks, the other half of the participants will not receive personalized automated alerts. After 4 weeks, these alerts will be enabled. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | The primary outcome measure will be the ten-item Perceived Stress Scale. Scores range from 0 to 40, and higher scores indicate more severe stress. | At 4 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | The primary outcome measure will be the ten-item Perceived Stress Scale. Scores range from 0 to 40, and higher scores indicate more severe stress. | At 12 weeks from baseline | 
| Active Data - Short UCLA Loneliness Scale | Short, 3-item scale; scores range from 3 to 9, and higher scores indicate more severe loneliness symptoms. Feasibility of the mobile platform will be indicated by a significant reduction in score. | At 4 weeks from baseline | 
| Active Data - Generalized Anxiety Disorder Scale | 7-item scale; scores range from 0 to 21, and higher scores indicate more severe anxiety symptoms. Feasibility of the mobile platform will be indicated by a significant reduction in score. | At 4 weeks from baseline | 
| Active Data - Patient Health Questionnaire | 9-item scale; scores range from 0 to 27, and higher scores indicate more severe depression symptoms. Feasibility of the mobile platform will be indicated by a significant reduction in score. | At 4 weeks from baseline | 
| Passive Data - GPS Sample Point Metrics | Feasibility of the mobile platform will be determined by the number of GPS sample points (mobility metrics) collected per user per day. | At 4 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Anxiety, Stress, Loneliness, Mobile Intervention