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Mental Health IssueNCT05514093

Beyond Silence: Advancing E-mental Health Solutions to Support Canadian Healthcare Workers

An observational study of Mental Health Issue and Mental Stress, run by McMaster University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Beyond Silence App
Type of treatment
Medical device
How many people
50,000 participants
Where
1 siteCanada
Study dates
1 Nov 2022to Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Who may be able to join

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

Who cannot join

  • Not able to access app on their smart device

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McMaster University

    Hamilton, Ontario, L8S 4L8

Other trials in Canada

About this study

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.

Read the detailed description

This project was designed to respond to the urgent and critical need for accessible mental health services and supports for front-line healthcare workers. Innovative solutions are needed to ensure the psychological health and safety of frontline workers and to ensure quality care for the millions of Canadians who relied on their services. This project provides an opportunity to study the implementation and impact of Beyond Silence, a new e-mental health approach to early intervention and peer support that was customized for healthcare workers.

The objectives of this study are to answer both implementation and impact questions:

Implementation:

  1. What are the patterns of app use among healthcare workers over a 3-6 month period?
  2. What factors influence how the app is utilized among workers in diverse healthcare organizations? Impact:
  3. Does use of the app increase mental health literacy among healthcare workers?
  4. Does the app increase outreach to peer support?
  5. Does outreach to peer support in the app reduce the level of distress?

This is a prospective cohort implementation study, studying the implementation and impact of the app over a 3-6 month period in participating healthcare organizations. The Consolidated Framework for Implementation Research (CFIR) informs the exploration of how the app is adopted and the individual and organizational forces that shape adoption. Pre/post impact data are being collected over the implementation period to assess whether the app leads to improved mental health knowledge among workers who use the app (primary outcome), and to increased access to peer support (secondary outcome).

Recruitment for this study is occuring on three levels: (1) organization (2) peer support providers (3) frontline healthcare workers. Eight to ten healthcare organizations across Canada have been recruited into the study, with at least one organizational champion who liaises with the research team. Champions are interviewed to understand the workplace context and create a communication plan. Each organization also nominates at least 4-5 peer support providers who are trained to provide service through the app. Frontline workers are invited to complete a baseline survey, then invited to download the app using an organizational code. Implementation takes place over a 3-6 month period; utilization patterns are tracked over time (aggregate data only). At the end of the trial, champions will be interviewed again to gather their feedback, and peer support providers will be invited to a focus group discussion to reflect on the implementation process. All employees are invited to complete a follow-up survey to gather their input and to track changes in mental health knowledge, mental distress, and help outreach. Implementation and impact data will be analyzed to identify trends within and across organizations.

The investigators are utilizing a multi-pronged approach to data collection via the following:

  1. App utilization data including adoption rates across each organization, as well as aggregate data on how often the app was used, average duration of use, the number of times different features were accessed, and how often users accessed links to the different types of peer support.
  2. App user impact - impact on app users is tracked through baseline and follow-up surveys to see if there are any statistically significant changes in mental health literacy, symptoms of mental distress (anxiety, depression, PTSD), burn-out, help outreach behaviours, and perceived psychological safety.
  3. Peer support provider focus group interviews will be conducted after the implementation period to explore providers' experiences facilitating peer support via the app.
  4. Organizational champion interviews will be conducted after the implementation period to explore organizational contextual factors.

Analysis of the collected survey data will examine change scores across the dataset as well as trends, with results disaggregated by gender, caregiver status, work role, organization, job tenure. Linear mixed models will be used to track changes over time in mental health knowledge (primary outcome), distress levels, and self-report of help-seeking/outreach. The model includes a fixed effect for time and random effects for organization types and participants. Age, gender, and caregiver status will be included in the models as covariates. The investigators also will explore potential predictors of outcomes using linear regression models (e.g., app usage, age, gender, education, role in organization - clinical/non-clinical). Additionally, qualitative content analysis will be used to examine focus group and interview data. All focus group and interview data are transcribed with the transcripts then reviewed and used for thematic analysis. Lastly, a cost-benefit analysis will be conducted to examine app implementation costs.

Being tested
Beyond Silence App
Keywords
Mental health, Peer support, Mobile health, Healthcare workers
Medical subject headings
Stress, Psychological, Stress Disorders, Post-Traumatic, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beyond Silence AppDevice

    Also called Beyond Silence

    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.

Study groups in NCT05514093
Study groupRoleWhat they receive
App usersAs this is a single cohort study, there is only one group consisting of the Beyond Silence app users.
Receives: Device: Beyond Silence App

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 3-6 months

Secondary outcomes (7)
  1. Change from baseline depression after implementation

    Depression will be assessed via the Patient Health Questionnaire-2 (PHQ-2), a brief and valid two item screening tool for the core symptoms depression

    Measured: Baseline, 3-6 months

  2. Change from baseline anxiety after implementation

    Symptoms of anxiety will be measured using the Generalized Anxiety Disorder Assessment-7 (GAD-7), which consists of seven questions answered via a 4-point Likert scale

    Measured: Baseline, 3-6 months

  3. Change from baseline post-traumatic stress disorder after implementation

    To assess PTSD, the PTSD Checklist for Diagnostic and Statistics Manual 5 (PCL-5) will be used, a 20-item standardized self-report measure that assesses the DSM-5 symptoms of PTSD over the past month

    Measured: Baseline, 3-6 months

  4. Change from baseline burn-out after implementation

    To assess mental distress related to burnout, the Maslach Burnout Inventory-2 (MBI-2) will be used. This validated burn-out screening tool consists of two questions answered via a 7-point Likert scale.

    Measured: Baseline, 3-6 months

  5. Change from baseline perceived psychological health and safety after implementation

    Perceived psychological health and safety in the workplace will be assessed via excerpts from StressAssess, a tool based on the Copenhagen validated Canadian survey. We are utilizing 13 questions from this survey, which are answered via variable Likert scale responses.

    Measured: Baseline, 3-6 months

  6. Change from baseline help outreach behavior after implementation

    Participants will be asked whether they have sought help for themselves or a colleague in the past 3 months. If yes, they will be asked to identify the type of help sought.

    Measured: Baseline, 3-6 months

  7. Peer support

    Following use of peer support services, app users will be invited to fill out an in-app survey immediately following the peer support interaction, asking service recipients to rate how they felt before and after the interaction (10-point Likert scale) and to comment on their experience.

    Measured: 3-to-6-month implementation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start1 Nov 2022
  3. Primary completionFeb 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05514093
Sponsor's protocol ID
14740
Status last verified
Oct 2023
First submitted
9 Aug 2022
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Moll S, Parker M, Smith P, Sykes E. Adoption of App-Based Peer Support by Canadian Health Care Providers: Mixed Methods Organizational Implementation Study. JMIR Mhealth Uhealth. 2026 Aug 5;14:e85658. doi: 10.2196/85658.

    PubMed 42555844

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health Issue and Mental Stress, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline mental health literacy after implementation (time frame: Baseline, 3-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05514093, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.

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