Stress Disorders, Post-TraumaticNCT04202042
Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers
A study testing Psychological first aid and Usual organisational intervention in people with Stress Disorders, Post-Traumatic and Acute Stress Disorder, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Acute Stress Disorder, Anxiety Disorders
- What is being tested?
- Psychological first aid and Usual organisational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 21 Oct 2019to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Actively working at Urgence-Santé organization as paramedics or emergency medical dispatchers
- Exposed to a traumatic event at work (after the baseline)
Who cannot join
- at high risk of suicidal behaviour
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Urgences-santé
Montreal, Quebec, H1P 0A4
Luc De Montigny, (514) 723-5600, luc.demontigny@urgences-sante.qc.ca
About this study
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic, Acute Stress Disorder, Anxiety Disorders, Depressive Disorder, Substance Abuse, Absenteeism
- Being tested
- Psychological first aid, Usual organisational intervention
- Keywords
- PFA, PTSD, Public safety personnel
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Acute, Anxiety Disorders, Depressive Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological first aidOther
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 interventionOther
Emergency intervention by workplace psychologist and limited therapeutic sessions with employee aid program
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Usual organisational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute stress symptoms
The Acute Stress Disorder Scale (Bryant, Moulds et Guthrie, 2000) Scores : 1 to 5, higher scores mean worse outcome.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Manual measurement (wrist or neck) of the resting heart rate at each measurement time Scores = pulse per minute, higher scores mean worse outcome
Measured: Baseline (T0) + each week until 90 to 95 days after the event
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.
Measured: 90 to 95 days after the traumatic event (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start21 Oct 2019
- Primary completionJul 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Geoffrion, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- Investigators
- Luc De Montigny, Principal investigator, Urgences-santéStephane Guay, Principal investigator, Research Center of the Institut universitaire en santé mentale de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202042
- Sponsor's protocol ID
- 162535
- Status last verified
- Dec 2019
- First submitted
- 11 Jul 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bryant RA. Acute stress reactions: can biological responses predict posttraumatic stress disorder? CNS Spectr. 2003 Sep;8(9):668-74. doi: 10.1017/s1092852900008853.
PubMed 15079140American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders DSM-5 (5e éd.). Arlington, VA: American Psychiatric Publishing
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
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.
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
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.
PubMed 10752364Ashbaugh 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.
PubMed 27723815Kroenke 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.
PubMed 11556941Spitzer 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.
PubMed 16717171Saunders 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.
PubMed 8329970Villalobos-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.
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.
PubMed 15085902
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-traumatic Stress Injuries Among Paramedics and Emergency Dispatchers
- ClinicalTrials.gov ID
- NCT04202042
- Acronym / sponsor ID
- 162535
- Conditions
- Stress Disorders, Post-Traumatic, Acute Stress Disorder, Anxiety Disorders, Depressive Disorder, Substance Abuse, Absenteeism
- Keywords
- PFA, PTSD, Public safety personnel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de MontréalUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological first aid | Experimental | Other: Psychological first aidPFA 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) |
| Usual organisational intervention | Active comparator | Other: Usual organisational interventionOne phone call by workplace psychologist (within the first 48 hours) and reference to employee aid program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Actively working at Urgence-Santé organization as paramedics or emergency medical dispatchers
- Exposed to a traumatic event at work (after the baseline)
Key exclusion criteria (1 listed)
- at high risk of suicidal behaviour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological first aidPFA 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 | Other | Psychological first aid |
| Usual organisational interventionEmergency intervention by workplace psychologist and limited therapeutic sessions with employee aid program | Other | Usual organisational intervention |
Primary outcome
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.
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.
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.
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
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
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
2 secondary outcomes
Change in heart rate variation
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 15079140Bryant RA. Acute stress reactions: can biological responses predict posttraumatic stress disorder? CNS Spectr. 2003 Sep;8(9):668-74. doi: 10.1017/s1092852900008853.
- BackgroundAmerican Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders DSM-5 (5e éd.). Arlington, VA: American Psychiatric Publishing
- BackgroundBrymer, 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
- BackgroundRuzek, 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.
- BackgroundWorld 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
- Background: PubMed 10752364Bryant 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.
- Background: PubMed 27723815Ashbaugh 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 8329970Saunders 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.
- BackgroundVillalobos-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: PubMed 15085902Skevington 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc De Montigny principal investigator
Urgences-santé
Stephane Guay principal investigator
Research Center of the Institut universitaire en santé mentale de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological first aid and Usual organisational intervention in people with Stress Disorders, Post-Traumatic and Acute Stress Disorder, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Geoffrion (+1 514 343-6111 ext. 5511, s.geoffrion@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202042, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.