Mobile Interventions for the Prevention and Detection of Distress

Depression Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072210
• Other study ID #: 20-176
• Secondary ID: SMH-20-037ML4258
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Loneliness
• Stress

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Unity Health Toronto	Toronto Metropolitan University, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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