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Mobile Interventions for the Prevention and Detection of Distress

Primary Purpose

Depression, Anxiety, Stress

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mobile Intervention
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Depression, Anxiety, Stress, Loneliness, Mobile Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 24, 2021
Last Updated
September 18, 2023
Sponsor
Unity Health Toronto
Collaborators
Toronto Metropolitan University, University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05072210
Brief Title
Mobile Interventions for the Prevention and Detection of Distress
Official Title
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?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
September 12, 2023 (Actual)
Study Completion Date
September 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Toronto Metropolitan University, University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Stress, Loneliness
Keywords
Depression, Anxiety, Stress, Loneliness, Mobile Intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Intervention Group
Arm Type
Experimental
Arm Description
One half of the participants will receive personalized automated alerts throughout their involvement.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
For 4 weeks, the other half of the participants will not receive personalized automated alerts. After 4 weeks, these alerts will be enabled.
Intervention Type
Other
Intervention Name(s)
Mobile Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
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.
Time Frame
At 4 weeks from baseline
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
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.
Time Frame
At 12 weeks from baseline
Title
Active Data - Short UCLA Loneliness Scale
Description
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.
Time Frame
At 4 weeks from baseline
Title
Active Data - Generalized Anxiety Disorder Scale
Description
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.
Time Frame
At 4 weeks from baseline
Title
Active Data - Patient Health Questionnaire
Description
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.
Time Frame
At 4 weeks from baseline
Title
Passive Data - GPS Sample Point Metrics
Description
Feasibility of the mobile platform will be determined by the number of GPS sample points (mobility metrics) collected per user per day.
Time Frame
At 4 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkat Bhat, MD MSc
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mobile Interventions for the Prevention and Detection of Distress

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