Post Traumatic Stress Disorder Clinical Trial
Official title:
Advancing Peer Support Programming to Address PTSD and Trauma Among Canadian Public Safety Personnel and Veterans
NCT number | NCT05429619 |
Other study ID # | 14731 |
Secondary ID | |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2, 2023 |
Est. completion date | April 2024 |
Verified date | April 2024 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A prospective cohort study design will be implemented across four sectors and multiple organizations sites to evaluate implementation and impact of the apps. Pre/post impact data will be collected over a six-month implementation period to assess whether the apps lead to increased Public Safety Personnel outreach to peer support (primary outcome), and to increased mental health literacy, and decreased mental distress (secondary outcomes). Recruitment will take place at three levels; 1) organizations (including knowledge users/organization champions), 2) peer support providers, and 3) public safety personnel employed within each participating organization. Sources of implementation and impact data for the six-month trial will include: 1) app utilization data, 2) knowledge user/organization champion interviews, 3) surveys with public safety personnel, 4) focus groups with peer support providers, and 5) implementation costs. Analysis will focus on both implementation and effectiveness to address the research questions related to the impact of the apps, as well as how the process and context of implementation shapes effectiveness.
Status | Active, not recruiting |
Enrollment | 950 |
Est. completion date | April 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Public Safety Personnel working in fire services, paramedic services, emergency communications and correctional services - Employed (full or part-time) by the participating organizations - Agree to download the PeerOnCall app on their mobile phone (Android or Apple) Exclusion Criteria: - Not able to access the app on their mobile health device |
Country | Name | City | State |
---|---|---|---|
Canada | Western University | London | Ontario |
Canada | Memorial University of Newfoundland | Saint John's | Newfoundland and Labrador |
Canada | Wilfrid Laurier University | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institute for Public Safety Research and Treatment, Fisheries and Marine Institute of Memorial University of Newfoundland, Memorial University of Newfoundland, Public Health Agency of Canada (PHAC), University of Regina, Western University, Wilfrid Laurier University |
Canada,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Digital literacy | Rating of knowledge and comfort level in using apps. Ratings from low to high levels of digital literacy. Hypothesis is that lower digital literacy will predict lower app use. The baseline scale provides descriptive data about levels of digital literacy across the organization. The follow-up scale provides descriptive data about perceived digital literacy. | Baseline, 3 months, 6 months | |
Other | Frequency of app use | Report of how often the app was used over the past 4 weeks, ranging from not at all to more than once a day. This data can be used to note dose/response (I.e., Higher app use might lead to greater impact) and to track app user over time. | 3 months, 6 months | |
Other | Timing of app use | Descriptive data of when the app is used the most. Can be used to report trends within/across sectors and organizations. This can also be used to cross-check with/against app utilization metrics. | 3 months, 6 months | |
Other | Rating of app | Users are asked to rate the value of 8 different features of the app on a 5-point Likert scale from very poor to excellent. Plus, an overall rating of the likelihood of continued use of the app on a 5-point Likert scale from definitely not to definitely. | 3 months, 6 months | |
Primary | Accessing peer support via phone or text via the PeerOnCall app (Frequency count) | Number of times PeerOnCall users within an organization create a connection with peer support providers via the app platform (Software analytics) | Monthly intervals from 1 to 6 months. | |
Secondary | Change in Mental Health Literacy (6 items, 7-point Likert scale rating) | Rating using a 7-point Likert scale of perceived improvement in dimensions of mental health literacy (Promote mental health, knowledge of how to identify and address mental health issues in self and others, how to identify relevant resources). Range 7-42 with higher scores indicating higher levels of perceived literacy. | Baseline, 3 months, 6 months | |
Secondary | Changes in symptoms of anxiety (GAD-7 screening tool) | The Generalised Anxiety Disorder (GAD-7) scale is a 7-item tool to evaluate anxiety symptoms over the past two weeks (4-point Likert scale ratings). Scores ranges from 0-21 with a score of 10 or more indicative of potential generalized anxiety disorder. | Baseline, 3 months, 6 months | |
Secondary | Change in symptoms of depression (PHQ-9 screening tool) | The Patient Health Questionnaire (PHQ-9) is a 9-item screening tool for depression. Scores range from 0-27, with a score of 10 or more indicative of major depression. | Baseline, 3 months, 6 months | |
Secondary | Change in symptoms of trauma (PTSD Checklist, PCL-5 short version) | The short version of the Post-Traumatic Stress Disorder Checklist (PCL-5) is a four-item PTSD screening checklist exploring responses to a stressful experience in terms of symptoms over the past month. Scores range from 0-16 with higher scores indicating more severe impairment. | Baseline, 3 months, 6 months | |
Secondary | Change in help-seeking behaviour | Rating of how likely to reach out for support related to four different types of support (In-person peer support, app-based peer support, professional support, and employee assistance program). Ratings on a 5-point scale from not at all likely to extremely likely. | Baseline, 3 months, 6 months | |
Secondary | Perceived value of the app | Questions about perceived impact adapted from the Mobile Rating Application Rating Scale (MARS) asks users to rate (on a 5-point Likert scale) the perceived value of the app on 7 items (Awareness of the importance of addressing mental health, reaching out for help and impact on mental health, perceived support, and ability to cope at work). | 3 months, 6 months | |
Secondary | Change in perceived level of stress | Rating of current level of stress on a 7-point Likert scale from very low to very high. | Baseline, 3 months, 6 months | |
Secondary | Change in perceptions of workplace psychological health and safety climate | Rating of psychological health and safety climate in the workplace on a 7-point Likert scale from toxic to excellent. | Baseline, 3 months, 6 months | |
Secondary | Change in current mental health challenges | Rating of current mental health challenges on a 100-point Visual Analogue scale from ill to healthy. | Baseline, 3 months, 6 months | |
Secondary | Impact on work | Questions about the number of hours users were scheduled/expected to work and the number of hours of work users missed because of the way they were feeling over the past 2 weeks. | Baseline, 3 months, 6 months |
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