Mobile Interventions for the Prevention and Detection of Distress

NCT05072210 | Completed

• 3 other identifiers: 20-176SMH-20-037ML42588
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety; Stress; Loneliness

Keywords

Depression; Anxiety; Stress; Loneliness; Mobile Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Perceived Stress Scale

  At 12 weeks from baseline

• Active Data - Short UCLA Loneliness Scale

  At 4 weeks from baseline

• Active Data - Generalized Anxiety Disorder Scale

  At 4 weeks from baseline

• Active Data - Patient Health Questionnaire

  At 4 weeks from baseline

• Passive Data - GPS Sample Point Metrics

  At 4 weeks from baseline

Study Arms (2)

Mobile Intervention Group

EXPERIMENTAL

One half of the participants will receive personalized automated alerts throughout their involvement.

Other: Mobile Intervention

Control Group

NO INTERVENTION

For 4 weeks, the other half of the participants will not receive personalized automated alerts. After 4 weeks, these alerts will be enabled.

Interventions

Mobile Intervention OTHER

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.

Mobile Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Staff or healthcare providers working at Unity Health Toronto
• 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)

You may not qualify if:

• Non-Unity Health Toronto staff

Sponsors & Collaborators

• Unity Health Toronto: lead
• Toronto Metropolitan University: collaborator
• University of Toronto: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Venkat Bhat, MD MSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be issued a specific ID number to be used within the mobile app to ensure that any identifiable information within this app will remain anonymous. A master linking log will serve as the only link between participants and the study data collected in the mobile app.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: October 8, 2021
• Study Start: May 1, 2021
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)