Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers

Anxiety Disorders Clinical Trial

Official title:

Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04202042
• Other study ID #: 162535
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: November 2020

Study information

• Verified date: December 2019
• Source: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
• Contact: Steve Geoffrion
• Phone: +1 514 343-6111
• Email: s.geoffrion[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Absenteeism
• Acute Stress Disorder
• Anxiety Disorders
• Depressive Disorder
• Disease
• Emergencies
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute
• Substance Abuse
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
Canada	Urgences-santé	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (12)

American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders DSM-5 (5e éd.). Arlington, VA: American Psychiatric Publishing

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. — View 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. — View Citation

Bryant RA. Acute stress reactions: can biological responses predict posttraumatic stress disorder? CNS Spectr. 2003 Sep;8(9):668-74. Review. — View 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

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. — View 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.

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. — View 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. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View 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.

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in acute stress symptoms	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)
Primary	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.	Baseline (T0) + 2 times after exposure to the traumatic event; 30 to 32 days (T3), 90 to 95 days (T4)
Primary	Change in depressive symptoms	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)
Primary	Change in anxiety symptoms	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)
Primary	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	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)
Primary	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	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	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	Baseline (T0) + each week until 90 to 95 days after the event
Secondary	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.	90 to 95 days after the traumatic event (T4)