Post Traumatic Stress DisorderCOVER PRO LTNCT05033223
Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services
A study testing PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic in people with Post Traumatic Stress Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO. In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2021to 16 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- Administrative and technical medical staff of the Hospices Civils de Lyon
- Contractual or holder
- Having participated in the COVER PRO study
- Working in one of the HCL phase 3 departments of the COVID-19 pandemic.
- Affiliated with a social security system
- Having signed an informed consent
Who cannot join
- Refusal to participate
- Major under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services and SAMU: Multicenter Cohort Study (COVid in EmeRgency PROfessionnals Long Term)
The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO. In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products. This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic. It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD. These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic
- Keywords
- post traumatic stress disorder, PTSD, emergency services, COVID-19, burn-out
- Medical subject headings
- Stress Disorders, Post-Traumatic, COVID-19, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemicOther
PCL-5 autoquestionnaire to make the PTSD diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Follow-up | Other | Not described Receives: Other: PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale
: Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening. The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life
Measured: 12 months after the end of the second Lockdown (December 2020)
Secondary outcomes (12)
Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale
Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening. The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life
Measured: 9months after the end of the second Lockdown (December 2020)
Anxiety evaluation at 12 months using HAD scale
Existence of anxious symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder
Measured: 12months after the end of the second Lockdown (December 2020)
Anxiety evaluation at 9 months using HAD scale
Existence of anxious symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder
Measured: 9months after the end of the second Lockdown (December 2020)
Depression evaluation at 12 months using HAD scale
Existence of depression symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder
Measured: 12months after the end of the second Lockdown (December 2020)
Depression evaluation at 9 months using HAD scale
Existence of depression symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder
Measured: 9months after the end of the second Lockdown (December 2020)
Presence of a Burn out at 12 months using the Maslach Burnot Inventory (MBI) scale
Burnout characterized by the Maslach burnout inventory scale. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout.
Measured: 12months after the end of the second Lockdown (December 2020)
Presence of a Burn out at 9 months using the MBI scale
Burnout characterized by the Maslach burnout inventory scale. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout.
Measured: 9months after the end of the second Lockdown (December 2020)
Work-related stress measured using Karasek questionnaire at 12 months
Work-related stress measured using Karasek questionnaire at 12 months
Measured: 12months after the end of the second Lockdown (December 2020)
Work-related stress measured using Karasek questionnaire at 9 months
Work-related stress measured using Karasek questionnaire at 9 months
Measured: 9months after the end of the second Lockdown (December 2020)
Consumption of psychoactive substances at 12 months
Change in the consumption of psychoactive substances at 12 months
Measured: 12months after the end of the second Lockdown (December 2020)
Percentage of patients with psychological Support at 12 months
Percentage of patients who benefit from a psychological support at 12 months
Measured: 12months after the end of the second Lockdown (December 2020)
Mean number of days of sick leave at 12 months
Mean number of days of sick leave at 12 months
Measured: 12months after the end of the second Lockdown (December 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start12 Oct 2021
- Primary completion16 Jan 2022
- Study completion16 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Letellier, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033223
- Sponsor's protocol ID
- 69HCL21_0311
- Acronym
- COVER PRO LT
- Status last verified
- Jan 2022
- First submitted
- 1 Sep 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services and SAMU: Multicenter Cohort Study (COVid in EmeRgency PROfessionnals Long Term)
- ClinicalTrials.gov ID
- NCT05033223
- Acronym / sponsor ID
- COVER PRO LT / 69HCL21_0311
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- post traumatic stress disorder, PTSD, emergency services, COVID-19, burn-out
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 16 Jan 2022 (actual)
- Study completion
- 16 Jan 2022 (actual)
- First posted
- 2 Sep 2021 (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.
The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO. In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products. This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic. It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD. These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up | Other | Other: PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults
- Administrative and technical medical staff of the Hospices Civils de Lyon
- Contractual or holder
- Having participated in the COVER PRO study
- Working in one of the HCL phase 3 departments of the COVID-19 pandemic.
Key exclusion criteria (2 listed)
- Refusal to participate
- Major under legal protection
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 |
|---|---|---|
| PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemicPCL-5 autoquestionnaire to make the PTSD diagnosis | Other | Follow-up |
Primary outcome
Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale
Time frame: 12 months after the end of the second Lockdown (December 2020)
: Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening. The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life
12 secondary outcomes
Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale
Time frame: 9months after the end of the second Lockdown (December 2020)
Anxiety evaluation at 12 months using HAD scale
Time frame: 12months after the end of the second Lockdown (December 2020)
Anxiety evaluation at 9 months using HAD scale
Time frame: 9months after the end of the second Lockdown (December 2020)
Depression evaluation at 12 months using HAD scale
Time frame: 12months after the end of the second Lockdown (December 2020)
Depression evaluation at 9 months using HAD scale
Time frame: 9months after the end of the second Lockdown (December 2020)
Presence of a Burn out at 12 months using the Maslach Burnot Inventory (MBI) scale
Time frame: 12months after the end of the second Lockdown (December 2020)
Presence of a Burn out at 9 months using the MBI scale
Time frame: 9months after the end of the second Lockdown (December 2020)
Work-related stress measured using Karasek questionnaire at 12 months
Time frame: 12months after the end of the second Lockdown (December 2020)
Work-related stress measured using Karasek questionnaire at 9 months
Time frame: 9months after the end of the second Lockdown (December 2020)
Consumption of psychoactive substances at 12 months
Time frame: 12months after the end of the second Lockdown (December 2020)
Percentage of patients with psychological Support at 12 months
Time frame: 12months after the end of the second Lockdown (December 2020)
Mean number of days of sick leave at 12 months
Time frame: 12months after the end of the second Lockdown (December 2020)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic in people with Post Traumatic Stress Disorder, run by Hospices Civils de Lyon at 1 site in France.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jan 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale (time frame: 12 months after the end of the second Lockdown (December 2020)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2022.