Mobile Interventions for the Prevention and Detection of Distress

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?

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stress; Anxiety; Loneliness
• Intervention / Treatment: Other: Mobile Intervention

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Intervention Group; One half of the participants will receive personalized automated alerts throughout their involvement.	Other: Mobile Intervention; 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.
No Intervention: Control Group; 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?

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: University of Toronto; Toronto Metropolitan University
• Investigators: Principal Investigator: Venkat Bhat, MD MSc, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Stress; Loneliness; Mobile Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 20-176; SMH-20-037 (Other Grant/Funding Number: St. Michael's Hospital AFP Innovation Fund); ML42588 (Other Grant/Funding Number: Roche Canada COVID-19 Innovation Challenge)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No