search
Back to results

Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers

Primary Purpose

Stress Disorders, Post-Traumatic, Acute Stress Disorder, Anxiety Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Psychological first aid
Usual organisational intervention
Sponsored by
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress Disorders, Post-Traumatic focused on measuring PFA, PTSD, Public safety personnel

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Urgences-santéRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychological first aid

Usual organisational intervention

Arm Description

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)

One phone call by workplace psychologist (within the first 48 hours) and reference to employee aid program

Outcomes

Primary Outcome Measures

Change in acute stress symptoms
The Acute Stress Disorder Scale (Bryant, Moulds et Guthrie, 2000) Scores : 1 to 5, higher scores mean worse outcome.
Change in post-traumatic stress symptoms
The Post-Traumatic Checklist-5 (Ashbaugh, Houle-Johnson, Herbert, El-Hage et Brunet, 2016) Scores : 0 to 4, higher scores mean worse outcome.
Change in depressive symptoms
The Patient Health Questionnaire-9 (Kroenke, Spitzer & Williams, 2001) Scores : 0 to 3, higher scores mean worse outcome.
Change in anxiety symptoms
The General Anxiety Disorder-7 scale (Spitzer, Kroenke, Williams & Löwe, 2006) Scores : 0 to 3, higher scores mean worse outcome
Change in substance abuse : alcohol
The Alcohol Use Disorders Identification Test (Saunders, Aasland, Babor, de la Fuente & Grant, 1993) Scores : 0 to 5, higher scores mean worse outcome
Change in substance abuse : drug
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

Change in heart rate variation
Manual measurement (wrist or neck) of the resting heart rate at each measurement time Scores = pulse per minute, higher scores mean worse outcome
Absenteeism at work
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.

Full Information

First Posted
July 11, 2019
Last Updated
December 15, 2019
Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
search

1. Study Identification

Unique Protocol Identification Number
NCT04202042
Brief Title
Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers
Official Title
Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

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
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.
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?": To assess the acceptability of PFA for EMT; To assess the implementation of PFA in Urgences-Santé; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Acute Stress Disorder, Anxiety Disorders, Depressive Disorder, Substance Abuse, Absenteeism
Keywords
PFA, PTSD, Public safety personnel

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychological first aid
Arm Type
Experimental
Arm Description
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)
Arm Title
Usual organisational intervention
Arm Type
Active Comparator
Arm Description
One phone call by workplace psychologist (within the first 48 hours) and reference to employee aid program
Intervention Type
Other
Intervention Name(s)
Psychological first aid
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual organisational intervention
Intervention Description
Emergency intervention by workplace psychologist and limited therapeutic sessions with employee aid program
Primary Outcome Measure Information:
Title
Change in acute stress symptoms
Description
The Acute Stress Disorder Scale (Bryant, Moulds et Guthrie, 2000) Scores : 1 to 5, higher scores mean worse outcome.
Time Frame
2 times after exposure to the traumatic event; 48-72 hours (T1), 7 to 9 days (T2)
Title
Change in post-traumatic stress symptoms
Description
The Post-Traumatic Checklist-5 (Ashbaugh, Houle-Johnson, Herbert, El-Hage et Brunet, 2016) Scores : 0 to 4, higher scores mean worse outcome.
Time Frame
Baseline (T0) + 2 times after exposure to the traumatic event; 30 to 32 days (T3), 90 to 95 days (T4)
Title
Change in depressive symptoms
Description
The Patient Health Questionnaire-9 (Kroenke, Spitzer & Williams, 2001) Scores : 0 to 3, higher scores mean worse outcome.
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)
Title
Change in anxiety symptoms
Description
The General Anxiety Disorder-7 scale (Spitzer, Kroenke, Williams & Löwe, 2006) Scores : 0 to 3, higher scores mean worse outcome
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)
Title
Change in substance abuse : alcohol
Description
The Alcohol Use Disorders Identification Test (Saunders, Aasland, Babor, de la Fuente & Grant, 1993) Scores : 0 to 5, higher scores mean worse outcome
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)
Title
Change in substance abuse : drug
Description
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
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)
Secondary Outcome Measure Information:
Title
Change in heart rate variation
Description
Manual measurement (wrist or neck) of the resting heart rate at each measurement time Scores = pulse per minute, higher scores mean worse outcome
Time Frame
Baseline (T0) + each week until 90 to 95 days after the event
Title
Absenteeism at work
Description
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.
Time Frame
90 to 95 days after the traumatic event (T4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Geoffrion
Phone
+1 514 343-6111
Ext
5511
Email
s.geoffrion@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marine Tessier
Phone
+1 438 388-1890
Email
marine.tessier@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc De Montigny
Organizational Affiliation
Urgences-santé
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephane Guay
Organizational Affiliation
Research Center of the Institut universitaire en santé mentale de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urgences-santé
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1P 0A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc De Montigny
Phone
(514) 723-5600
Email
luc.demontigny@urgences-sante.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15079140
Citation
Bryant RA. Acute stress reactions: can biological responses predict posttraumatic stress disorder? CNS Spectr. 2003 Sep;8(9):668-74. doi: 10.1017/s1092852900008853.
Results Reference
background
Citation
American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders DSM-5 (5e éd.). Arlington, VA: American Psychiatric Publishing
Results Reference
background
Citation
Brymer, M. Jacobs, A. Layne, C., Pynoos, R., Ruzek, J., Steinberg, A., Vernberg. E. & Watson, P. (2006). Psychological First Aid: Field Operations Guide: 2nd Edition. National Child Traumatic Stress Network. Doi:10.1037/e536202011-001
Results Reference
background
Citation
Ruzek, J. I., Brymer, M. J., Jacobs, A. K., Layne, C. M., Vernberg, E. M. & Watson, P. J. (2007). Psychological first aid. Journal of Mental Health Counseling, 29(1), 17-49.
Results Reference
background
Citation
World Health Organization. (2013). Guidelines for the management of conditions that are specifically related to stress. World Health Organization. Retrieved from : http://apps.who.int/iris/bitstream/handle/10665/85119/9789241505406_eng.pdf;jsessionid=D6D881FC3D93CED2372C36AEC4F7C8EE?sequence=1
Results Reference
background
PubMed Identifier
10752364
Citation
Bryant RA, Moulds ML, Guthrie RM. Acute Stress Disorder Scale: a self-report measure of acute stress disorder. Psychol Assess. 2000 Mar;12(1):61-8.
Results Reference
background
PubMed Identifier
27723815
Citation
Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016.
Results Reference
background
PubMed Identifier
11556941
Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
background
PubMed Identifier
16717171
Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Results Reference
background
PubMed Identifier
8329970
Citation
Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
Results Reference
background
Citation
Villalobos-Gallegos, L., Perez-Lopez, A., Graue-Moreno, J., Marin-Navarrete, R., & Mendoza-Hassey, R. (2015). Psychometric and diagnostic properties of the Drug Abuse Screening Test (DAST): Comparing the DAST-20 vs. the DAST-10. Salud Mental, 38, 2, 89-94.
Results Reference
background
PubMed Identifier
15085902
Citation
Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
Results Reference
background

Learn more about this trial

Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers

We'll reach out to this number within 24 hrs