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

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05514093
• Other study ID #: 14740
• Status: Active, not recruiting
• Start date: November 1, 2022
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Beyond Silence has received an additional year of funding to scale implementation across 4-6 additional healthcare organizations.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50000
• Est. completion date: March 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Employees (full-time or part-time) at participating healthcare organizations

• Agree to download the Beyond Silence app to their mobile phone (Apple or Android)

Exclusion Criteria:

• Not able to access app on their smart device

Related Conditions & MeSH terms

• Mental Health Issue
• Mental Stress
• Moral Injury
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress, Psychological

Intervention

Device:
• Beyond Silence App
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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Public Health Agency of Canada (PHAC)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline, 3-6 months
Secondary	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	Baseline, 3-6 months
Secondary	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	Baseline, 3-6 months
Secondary	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.	Baseline, 3-6 months
Secondary	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.	Baseline, 3-6 months
Secondary	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.	Baseline, 3-6 months
Secondary	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.	3-to-6-month implementation period