- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05530642
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
November 30, 2023 updated by: University of Regina
Public safety personnel (PSP; e.g., border services personnel, correctional workers, firefighters, paramedics, police, public safety communicators) are frequently exposed to potentially psychologically traumatic events.
Such events contribute to substantial and growing challenges from posttraumatic stress injuries (PTSIs), including but not limited to posttraumatic stress disorder.
The PSP PTSI Study has been designed to evaluate an evidence-informed, proactive system of mental health assessment and training among Royal Canadian Mounted Police (www.rcmpstudy.ca) for delivery among diverse PSP (i.e., firefighters, municipal police, paramedics, public safety communicators).
The training is based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, adapted for PSP, and named Emotional Resilience Skills Training (ERST).
The subsequent PSP PTSI Study results are expected to benefit the mental health of all participants and, ultimately, all PSP.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Public safety personnel (PSP; e.g., border services personnel, correctional workers, firefighters, paramedics, police, public safety communicators) are frequently exposed to potentially psychologically traumatic events.
Such events contribute to substantial and growing challenges from posttraumatic stress injuries (PTSIs), including but not limited to posttraumatic stress disorder.
The PSP PTSI Study has been designed to evaluate an evidence-informed, proactive system of mental health assessment and training among Royal Canadian Mounted Police (www.rcmpstudy.ca) for delivery among diverse PSP (i.e., firefighters, municipal police, paramedics, public safety communicators).
The training is based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, adapted for PSP, and named Emotional Resilience Skills Training (ERST).
Specifically, the PSP PTSI Study will: 1) adapt, implement, and assess the impact of a system for ongoing (i.e., annual, monthly, daily) evidence-based assessments; 2) evaluate associations between demographic variables and PTSI; 3) longitudinally assess individual differences associated with PTSI; and, 4) assess the impact of providing diverse PSP with a tailored version of the ERST originally developed for the Royal Canadian Mounted Police in mitigating PTSIs based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders.
Participants are assessed at pre-training; week 1 (i.e., Time 1) and post-training; week 13 (i.e., Time 2), and then at a 1-year follow-up after training, during week 65 (Time 3).
The assessments include clinical interviews, self-report surveys including brief daily and monthly assessments, and daily biometric data.
The PSP PTSI Study hypotheses were pre-registered with aspredicted.org
for the PSP PTSI Study and associated hypotheses occurred on March 7, 2022 with the name, "An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel" (#90136).
Hypotheses specific to individual difference variables are publicly available; however, the overarching PSP PTSI Study hypotheses are: 1) participant mental health disorder prevalence at Time 1, based on Clinical Interviews or screening tools based on self-reported symptoms, will be higher than would be expected for the general population; 2) from Time 1 to Time 2, participants will evidence reductions in risk, increases in resiliency, and improvements in mental health, as a function of the ERST; 3) participants will evidence statistically significant predictive relationships between completing assessments and changes to individual differences over time (i.e., inversely with risk, positively with resilience, positively with mental health); 4) participants will evidence statistically significant sequential predictive relationships for environmental factors or individual differences reported during the Daily Assessments, Monthly Assessments, and Full Assessments; 5) all participants will evidence sustained reductions in risk, increases in resilience, and increases in mental health at Time 3 relative to Time 2; 6) participants will evidence a statistically significant relationship between changes in individual differences over time and engagement with ERST content; 7) participants will evidence a statistically significant relationship between changes in environmental factors or individual differences over time, frequency of exercise, and other self-reported indicators of physical health; 8) relative to men, women will report more difficulties with mental disorder symptoms and occupational stressors; 9) diastole will be reduced in PSP who report symptoms consistent with one or more PTSI; 10) the biometric data will be statistically significantly and substantively correlated with measures of PTSI; 11) there will be a statistically significant and substantive relationship between PTSI symptom severity and reduced diastolic function; and 12) changes in biological variables (i.e., autonomic nervous system reactivity, heart rate variability, cardiac mechanical changes) will be associated with environmental factors or individual differences.
The subsequent PSP PTSI Study results are expected to benefit the mental health of all participants and, ultimately, all PSP.
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saskatchewan
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Regina, Saskatchewan, Canada, S4S0A2
- University of Regina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Currently serving PSP firefighters, municipal police officers, paramedics, and public safety communicators
- Potential participants were Canadian citizens or permanent residents
- 18 years or older
- Fluently read, write, and speak either English or French
- Employed in their PSP sector for a minimum of three years
- Access to a computer with internet service
Exclusion Criteria:
- High risk of suicide or previous suicide attempt/hospitalization within the prior year
- Currently experiencing psychosis, mania
- Currently experiencing impairing drug or alcohol addictions
- Current or ongoing performance management concerns
- Any history of advocating against mental health care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emotional Resilience Skills Training (ERST)
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based cognitive-behavioral intervention designed to cultivate constructive approach-oriented emotional engagement.
The 13-week Emotional Resilience Training (ERST) is an adaptation of the UP designed for use as a proactive training course.
The ERST frames emotional experiences as natural responses to threat, rather than pathological occurrences to avoid; as such, the ERST is well-suited for mitigating health challenges and the skills may also help PSP to support persons in distress, including other PSP and the community members they all serve.
The ERST training materials include an instructor guide, didactic PowerPoints, and a trainee workbook.
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The ERST training is designed as a "train the trainer" model.
Sauer-Zavala, a co-developer of the UP, personally trained a group of PSP trainers from each of the PSP pilot sectors (i.e., CanOps, Regina Fire & Protective Services, Regina Police Service, Saskatoon Police Service, Regina Emergency Medical Services, Ottawa Emergency Medical Services) during a week-long interactive workshop.
The trainers continue to have access to Sauer-Zavala for optional follow-up consultation and support related to delivery of the ERST training for questions or to address any issues that arise during training.
Having consultation and support available for the trainers should help to offset concerns raised about ensuring training fidelity subsequent to other mental health programs.
Participants have ongoing access to ERST to support skill retention after training is completed, which should help to offset previous indications of problems with skill development for mental health programs.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Posttraumatic Stress Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Time Frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
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Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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Sustained Posttraumatic Stress Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Time Frame: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
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Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
|
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Change in Major Depressive Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Time Frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
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Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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Sustained Major Depressive Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Time Frame: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
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Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Time Frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
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Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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Sustained Generalized Anxiety Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Time Frame: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
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Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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Change in Panic Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Time Frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
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Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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Sustained Panic Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Time Frame: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
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Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: R. Nicholas Carleton, PhD, University of Regina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2020
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
August 29, 2022
First Submitted That Met QC Criteria
September 1, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Estimated)
December 4, 2023
Last Update Submitted That Met QC Criteria
November 30, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Stress, Psychological
- Occupational Stress
- Mental Fatigue
- Fatigue
- Depressive Disorder
- Anxiety Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Wounds and Injuries
- Compassion Fatigue
- Depressive Disorder, Major
- Panic Disorder
- Trauma and Stressor Related Disorders
Other Study ID Numbers
- 2020-226
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are ethical and privacy concerns with respect to sharing the participant data, even after anonymization; as such, requests to access the datasets should be directed to the primary investigator and will be addressed on a case-by-case basis in connection with the University of Regina Research Ethics Board.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.