Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers

As part of their work, emergency first responders, such as paramedics and emergency medical dispatchers are exposed daily to traumatic events. These traumatic events can have many impacts on mental health, such as acute stress disorder and post-traumatic stress disorder. Research has shown that intervening early after exposure to a traumatic event helps to identify people at risk and to prevent post-traumatic stress disorder. The Psychological First Aid approach originally developed for mass traumas, is an intervention advocated by international experts today following a traumatic event. However, this approach is still very little studied, especially when it is part of an organization of emergency first responders. It therefore still lacks scientific validity. The main objective of this research will be to assess whether the Psychological First Aid program provided by peer-support workers helps to reduce the initial distress caused by traumatic events and to foster short- and long-term adaptive functioning and coping.

Study Overview

Detailed Description

In May 2018, Urgences-Santé (i.e., EMT corporation for the Montreal area) implemented PFA as a peer-support intervention for EMT affected by traumatic events in the course of their work. In collaboration with Urgences-Santé, this project aims to evaluate the feasibility of PFA as a post-traumatic peer-support intervention among EMT. Feasibility studies are used to determine whether an intervention should be recommended for efficacy testing when there are few previously published studies or existing data using a specific intervention technique. This catalyst project relies on participatory research principles. With Urgences-Santé stakeholders, three specific research objectives were elaborated in order to answer the question "Can PFA work for EMT?":

  1. To assess the acceptability of PFA for EMT;
  2. To assess the implementation of PFA in Urgences-Santé;
  3. To test the limited-efficacy (i.e., efficacy within limitations such as small sample size and convenience sampling of PFA among Urgences-Santé trauma-exposed EMT).

Based on the few studies that assess different aspects of the feasibility of PFA in high-risk organizations, this project relies on three working hypotheses. First, we expect that PFA be acceptable among EMT. Second, we stipulate that few obstacles limited the implementation of PFA in Urgences-Santé given that this organization followed Forbes' implementation framework and favored a train-the-trainer approach. Third, we foresee that PFA will accelerate the recovery process of EMT, as measured by a greater decrease in PTSI, heart rate and absenteeism in the days following the traumatic event among those who received PFA compared to those who received the standard intervention (i.e., reference to employee aid program). If confirmed, these hypotheses will allow us to affirm that PFA can work as a post-traumatic intervention among EMT for the prevention of PTSI. Our results would therefore represent a catalyst towards a larger RCT that would answer the question "Does PFA work for EMT?" with an adequate sample size.

Study Type

Interventional

Enrollment (Anticipated)

70

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

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Actively working at Urgence-Santé organization as paramedics or emergency medical dispatchers
  • Exposed to a traumatic event at work (after the baseline)

Exclusion Criteria:

- at high risk of suicidal behaviour

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: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Psychological first aid
PFA responders are trained to deliver 8 core actions in the aftermath of traumatic event (: contact and engagement, safety and comfort, stabilization, information gathering, practical assistance, connection with social supports, information on coping, and linkage with collaborative services (within the first 24 hours)
PFA responders (peer support workers) are trained to deliver 8 core actions: contact and engagement, safety and comfort, stabilization, information gathering, practical assistance, connection with social supports, information on coping, and linkage with collaborative services
ACTIVE_COMPARATOR: Usual organisational intervention
One phone call by workplace psychologist (within the first 48 hours) and reference to employee aid program
Emergency intervention by workplace psychologist and limited therapeutic sessions with employee aid program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in acute stress symptoms
Time Frame: 2 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2)
The Acute Stress Disorder Scale (Bryant, Moulds et Guthrie, 2000) Scores : 1 to 5, higher scores mean worse outcome.
2 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2)
Change in post-traumatic stress symptoms
Time Frame: Baseline (T0) + 2 times after exposure to the traumatic event; 30 to 32 days (T3), 90 to 95 days (T4)
The Post-Traumatic Checklist-5 (Ashbaugh, Houle-Johnson, Herbert, El-Hage et Brunet, 2016) Scores : 0 to 4, higher scores mean worse outcome.
Baseline (T0) + 2 times after exposure to the traumatic event; 30 to 32 days (T3), 90 to 95 days (T4)
Change in depressive symptoms
Time Frame: 4 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2), 30 to 32 days (T3), 90 to 95 days (T4)
The Patient Health Questionnaire-9 (Kroenke, Spitzer & Williams, 2001) Scores : 0 to 3, higher scores mean worse outcome.
4 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2), 30 to 32 days (T3), 90 to 95 days (T4)
Change in anxiety symptoms
Time Frame: 4 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2), 30 to 32 days (T3), 90 to 95 days (T4)
The General Anxiety Disorder-7 scale (Spitzer, Kroenke, Williams & Löwe, 2006) Scores : 0 to 3, higher scores mean worse outcome
4 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2), 30 to 32 days (T3), 90 to 95 days (T4)
Change in substance abuse : alcohol
Time Frame: 4 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2), 30 to 32 days (T3), 90 to 95 days (T4)
The Alcohol Use Disorders Identification Test (Saunders, Aasland, Babor, de la Fuente & Grant, 1993) Scores : 0 to 5, higher scores mean worse outcome
4 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2), 30 to 32 days (T3), 90 to 95 days (T4)
Change in substance abuse : drug
Time Frame: 4 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2), 30 to 32 days (T3), 90 to 95 days (T4)
The Drug Abuse Screening Test (Villalobos-Gallegos, Perez-Lopez, Graue-Moreno, Marin-Navarrete & Mendoza-Hassey, 2015) Scores : Yes or No, higher "Yes" answers mean worse outcome
4 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2), 30 to 32 days (T3), 90 to 95 days (T4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in heart rate variation
Time Frame: Baseline (T0) + each week until 90 to 95 days after the event
Manual measurement (wrist or neck) of the resting heart rate at each measurement time Scores = pulse per minute, higher scores mean worse outcome
Baseline (T0) + each week until 90 to 95 days after the event
Absenteeism at work
Time Frame: 90 to 95 days after the traumatic event (T4)
Number of days taken off of work for psychological reasons from the time of traumatic exposure up to T4. Information requested directly from participants in the questionnaire set.
90 to 95 days after the traumatic event (T4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Luc De Montigny, Urgences-Sante
  • Principal Investigator: Stephane Guay, Research center of the Institut universitaire en santé mentale de Montréal

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.

General Publications

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)

October 21, 2019

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

December 15, 2019

First Posted (ACTUAL)

December 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 15, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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