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An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel

Primary Purpose

Posttraumatic Stress Disorder, Major Depressive Disorder, Panic Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Emotional Resilience Skills Training (ERST)
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Regina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Emotional Resilience Skills Training (ERST)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Posttraumatic Stress Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
Sustained Posttraumatic Stress Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
Change in Major Depressive Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
Sustained Major Depressive Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Sustained Generalized Anxiety Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Change in Panic Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Sustained Panic Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2022
Last Updated
September 1, 2022
Sponsor
University of Regina
Collaborators
Canadian Institutes of Health Research (CIHR), Canadian Institute for Public Safety Research and Treatment, Saskatchewan Ministry of Justice and Attorney General, Association of Public Safety Communication Officials, Frontenac Paramedic Services, Ottawa Paramedic Service, Paramedic Services Chiefs of Saskatchewan, Peterborough County-City Paramedics, Regina Fire and Protective Services, Saskatchewan Association of Chiefs of Police, Saskatchewan Federation of Police Officers, Saskatchewan Health Authority - Regina Area
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1. Study Identification

Unique Protocol Identification Number
NCT05530642
Brief Title
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
Official Title
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
Collaborators
Canadian Institutes of Health Research (CIHR), Canadian Institute for Public Safety Research and Treatment, Saskatchewan Ministry of Justice and Attorney General, Association of Public Safety Communication Officials, Frontenac Paramedic Services, Ottawa Paramedic Service, Paramedic Services Chiefs of Saskatchewan, Peterborough County-City Paramedics, Regina Fire and Protective Services, Saskatchewan Association of Chiefs of Police, Saskatchewan Federation of Police Officers, Saskatchewan Health Authority - Regina Area

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Major Depressive Disorder, Panic Disorder, Generalized Anxiety Disorder, Trauma, Traumatic Stress Disorder, Trauma and Stressor Related Disorders, Vicarious Trauma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The PSP PTSI Study uses a longitudinal prospective sequential experimental cohort design that engages each participant for approximately 16 months. Several practical constraints prohibited a randomized controlled trial, including resource limitations and probable interactions between PSP during and after training.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Emotional Resilience Skills Training (ERST)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Resilience Skills Training (ERST)
Other Intervention Name(s)
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Posttraumatic Stress Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Description
Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
Time Frame
Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
Title
Sustained Posttraumatic Stress Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Description
Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
Time Frame
Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
Title
Change in Major Depressive Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Description
Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
Time Frame
Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
Title
Sustained Major Depressive Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Description
Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
Time Frame
Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
Title
Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Description
Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Time Frame
Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
Title
Sustained Generalized Anxiety Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Description
Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Time Frame
Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
Title
Change in Panic Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Description
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Time Frame
Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
Title
Sustained Panic Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Description
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Time Frame
Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Nicholas Carleton, PhD
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S0A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
35993603
Citation
Carleton RN, Kratzig GP, Sauer-Zavala S, Neary JP, Lix LM, Fletcher AJ, Afifi TO, Brunet A, Martin R, Hamelin KS, Teckchandani TA, Jamshidi L, Maguire KQ, Gerhard D, McCarron M, Hoeber O, Jones NA, Stewart SH, Keane TM, Sareen J, Dobson K, Asmundson GJG. The Royal Canadian Mounted Police (RCMP) Study: protocol for a prospective investigation of mental health risk and resilience factors. Health Promot Chronic Dis Prev Can. 2022 Aug;42(8):319-333. doi: 10.24095/hpcdp.42.8.02.
Results Reference
background
Links:
URL
https://www.saskptsistudy.ca
Description
PSP PTSI Study Website
URL
https://www.rcmpstudy.ca
Description
RCMP Study Website

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An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel

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