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OpenTrials
Completed

NCT Number: NCT05072210

Mobile Interventions for the Prevention and Detection of Distress

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Loneliness Mental Disorders Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Perceived Stress Scale

    Time frame: At 4 weeks from baseline

    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 outcomes

  1. Perceived Stress Scale

    Time frame: At 12 weeks from baseline

    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.

  2. Active Data - Short UCLA Loneliness Scale

    Time frame: At 4 weeks from baseline

    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.

  3. Active Data - Generalized Anxiety Disorder Scale

    Time frame: At 4 weeks from baseline

    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.

  4. Active Data - Patient Health Questionnaire

    Time frame: At 4 weeks from baseline

    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.

  5. Passive Data - GPS Sample Point Metrics

    Time frame: At 4 weeks from baseline

    Feasibility of the mobile platform will be determined by the number of GPS sample points (mobility metrics) collected per user per day.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Toronto Metropolitan University
  • University of Toronto

Registry information

Official study 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?

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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