Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers

Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal (Other)
Overall Status
Unknown status
CT.gov ID
NCT04202042
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
12.4
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Psychological first aid
  • Other: Usual organisational intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers
Actual Study Start Date :
Oct 21, 2019
Anticipated Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Nov 1, 2020

Arms and Interventions

ArmIntervention/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)

Other: Psychological first aid
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

Other: Usual organisational intervention
Emergency intervention by workplace psychologist and limited therapeutic sessions with employee aid program

Outcome Measures

Primary Outcome Measures

  1. Change in acute stress symptoms [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. Change in post-traumatic stress symptoms [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.

  3. Change in depressive symptoms [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. Change in anxiety symptoms [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

  5. Change in substance abuse : alcohol [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

  6. Change in substance abuse : drug [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

Secondary Outcome Measures

  1. Change in heart rate variation [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

  2. Absenteeism at work [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Urgences-santéMontréalQuebecCanadaH1P 0A4

Sponsors and Collaborators

  • Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Steve Geoffrion, Researcher and Assistant professor, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
ClinicalTrials.gov Identifier:
NCT04202042
Other Study ID Numbers:
  • 162535
First Posted:
Dec 17, 2019
Last Update Posted:
Dec 17, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Steve Geoffrion, Researcher and Assistant professor, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 17, 2019