NCT04202042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

July 11, 2019

Last Update Submit

December 15, 2019

Conditions

Keywords

PFAPTSDPublic safety personnel

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (2)

  • Change in heart rate variation

    Baseline (T0) + each week until 90 to 95 days after the event

  • Absenteeism at work

    90 to 95 days after the traumatic event (T4)

Study Arms (2)

Psychological first aid

EXPERIMENTAL

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

Usual organisational intervention

ACTIVE COMPARATOR

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

Other: Usual organisational intervention

Interventions

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

Psychological first aid

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

Usual organisational intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- at high risk of suicidal behaviour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urgences-santé

Montreal, Quebec, H1P 0A4, Canada

RECRUITING

Related Publications (12)

  • Bryant RA. Acute stress reactions: can biological responses predict posttraumatic stress disorder? CNS Spectr. 2003 Sep;8(9):668-74. doi: 10.1017/s1092852900008853.

    PMID: 15079140BACKGROUND
  • American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders DSM-5 (5e éd.). Arlington, VA: American Psychiatric Publishing

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • Guidelines for the Management of Conditions Specifically Related to Stress. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK159725/

    PMID: 24049868BACKGROUND
  • 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.

    PMID: 10752364BACKGROUND
  • 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.

    PMID: 27723815BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • 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.

    PMID: 8329970BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 15085902BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticStress Disorders, Traumatic, AcuteAnxiety DisordersDepressive DisorderSubstance-Related Disorders

Interventions

Psychological First Aid

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersMood DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Emergency Services, PsychiatricMental Health ServicesBehavioral Disciplines and Activities

Study Officials

  • Luc De Montigny

    Urgences-santé

    PRINCIPAL INVESTIGATOR
  • Stephane Guay

    Research Center of the Institut universitaire en santé mentale de Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher and Assistant professor

Study Record Dates

First Submitted

July 11, 2019

First Posted

December 17, 2019

Study Start

October 21, 2019

Primary Completion

July 1, 2020

Study Completion

November 1, 2020

Last Updated

December 17, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations