NCT05514093

Brief Summary

The purpose of this project is to scale implementation and evaluation of an m-health app designed to promote early intervention and mental health support for frontline healthcare workers to reduce their risk of post-traumatic stress disorder (PTSD) and/or the mental health impact of the COVID-19 pandemic. Beyond Silence has received an additional year of funding to scale implementation across 4-6 additional healthcare organizations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

August 9, 2022

Last Update Submit

October 2, 2023

Conditions

Keywords

Mental healthPeer supportMobile healthHealthcare workers

Outcome Measures

Primary Outcomes (1)

  • Change from baseline mental health literacy after implementation

    The primary outcome is changes in mental health knowledge scores from baseline to follow-up among app users. Mental health literacy regarding how to identify and address mental health issues in the workplace will be rated on a 7-point scale of perceived knowledge.

    Baseline, 3-6 months

Secondary Outcomes (7)

  • Change from baseline depression after implementation

    Baseline, 3-6 months

  • Change from baseline anxiety after implementation

    Baseline, 3-6 months

  • Change from baseline post-traumatic stress disorder after implementation

    Baseline, 3-6 months

  • Change from baseline burn-out after implementation

    Baseline, 3-6 months

  • Change from baseline perceived psychological health and safety after implementation

    Baseline, 3-6 months

  • +2 more secondary outcomes

Study Arms (1)

App users

As this is a single cohort study, there is only one group consisting of the Beyond Silence app users.

Device: Beyond Silence App

Interventions

The Beyond Silence app is designed to be a "mental health coach in your pocket" for healthcare workers. It provides opportunities to build mental health literacy and reduce barriers to seeking support, including access to peer support either within or outside the organization.

Also known as: Beyond Silence
App users

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of healthcare workers of all ages and genders (from frontline workers to middle and high-level management) in the participating organizations. Frontline healthcare workers include any staff providing direct patient services (e.g., personal support workers, healthcare aids, nursing. physician, allied health) as well as non-clinical staff (e.g. management, administration).

You may qualify if:

  • Employees (full-time or part-time) at participating healthcare organizations
  • Agree to download the Beyond Silence app to their mobile phone (Apple or Android)

You may not qualify if:

  • Not able to access app on their smart device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Stress, PsychologicalStress Disorders, Post-TraumaticPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPersonal Satisfaction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 24, 2022

Study Start

November 1, 2022

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations