Covid19EMOCOVNCT04794920
Post-Covid-19 Emotional Aspects of Hospital Staff
An observational study of Covid19, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The ongoing SARS-CoV2 or Covid-19 pandemic is causing a major global health crisis. In France, it prompted an urgent reorganization of the healthcare supply, mobilizing caregivers and hospital staff in a climate of uncertainty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 780 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2020to 9 Jan 2023
- Phase
- Observational
- 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
Study population: Any staff (caregivers and non-carers) who worked during the Covid 19 crisis (from March 15 to May 15) at the GHPSJ, on site or by teleworking, all or part of the period
Who may be able to join
- Any staff (caregivers and non-carers) who worked during the Covid 19 crisis (from March 15 to May 15) at the GHPSJ, on site or by teleworking, all or part of the period.
Who cannot join
- Opposition to participate in research.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
About this study
The ongoing SARS-CoV2 or Covid-19 pandemic is causing a major global health crisis. In France, it prompted an urgent reorganization of the healthcare supply, mobilizing caregivers and hospital staff in a climate of uncertainty. Health services have been put to the test, some staff being on the front line, others having faced the reorganization of the health system necessitated by such a pandemic.
Frontline caregivers have been compared to "fighters on the front lines." They encountered many difficulties, such as direct exposure to patients with a high viral load, exposure to the risk of contamination, physical exhaustion, reorganization of workspaces, adaptation to rigid work organizations, the management of the shortage of materials, the unusually high number of deaths among patients, colleagues or relatives, ethical questions relating to decision-making in a strained healthcare system.
Read more
The psychological impact on these hospital staff is an indirect issue of such a pandemic in terms of mental health.
The investigators have little data in the literature on the incidence of psychiatric episodes in the post-epidemic period. Work on the impact of two major pandemics of influenza A H1N1 (2009) and SARS-CoV-1 (2003) on the mental health of caregivers and other staff working in hospitals reports increased rates of mental disorders after discharge from anxiety-type crisis, depression and post-traumatic stress. This over-representation of mental disorders was still found several years after the epidemic.
Similar results are emerging in recent studies involving hospital staff who were used in the Covid-19 crisis. These highlight a certain number of risk factors for the occurrence of these disorders (young age, nursing profession, underlying psychiatric pathology, exercise carried out in the first line of Covid).
Read the detailed description
At the Paris Saint-Joseph Hospital Group (GHPSJ), a multidisciplinary working group was early involved in psychological support for staff.
This group proposed the establishment of on-call duty entrusted to a psychological support unit, made up of a doctor, a nurse and a psychologist who volunteered to carry out patrols in the various departments of the hospital. These visits, sometimes organized at the request of the management of the services and sometimes improvised, aimed to identify the difficulties encountered in the field, and to discuss with the teams.
Concomitantly and complementary, the staff bubble opened at the Paris Saint-Joseph Hospital on March 27, to offer a decompression space to all staff (caregivers or not) with proposals for hypnosis, physiotherapy, sophrology sessions. , psychotherapy, but also informal discussions or a break in a relaxing armchair.
As a continuation of this approach, the multidisciplinary working group plans to search in July 2020 for symptoms present in certain mental illnesses (anxiety, depression, post-traumatic stress syndrome) in all the staff of the Paris Saint-Joseph Hospital Group. , now that the crisis seems to be receding. This will make it possible to adapt the support offer for staff in the coming months. This inventory will be made on the basis of validated questionnaires: the Posttraumatic stress disorder CheckList-5 (PCL) questionnaire for post-traumatic stress and the Hospital Anxiety and Depression scale (HAD) score for mental disorders (anxiety, depression) . A 3rd questionnaire will collect additional data and provide feedback on the frequentation of the bubble
- Conditions
- Covid19
- Keywords
- Emotional aspects, caregivers
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of symptoms related to post-traumatic stress in all staff who worked at the GHPSJ during the crisis (from March 15 to May 15, 2020).
Rate of staff with a score> 44 on the PCL questionnaire
Measured: Day 1
Frequency of symptoms related to post-traumatic stress in all staff who worked at the GHPSJ during the crisis (from March 15 to May 15, 2020).
Rate of staff with a score ≥11 on items A and D for the HAD score
Measured: Day 1
Secondary outcomes (7)
Look for demographic and professional characteristics that may favor the onset of these symptoms
Univariate and multivariate analyzes to identify the risk factors for the occurrence of these symptoms (anxiety, depression and post-traumatic stress)
Measured: Day 1
Evaluate the impact of frequentation of the staff bubble on the occurrence of anxiety / depressive disorders
Difference between the average HAD scores between the group "frequentation of the staff bubble" and the group "non-attendance of the staff bubble". The distinction between the 2 groups is made on the basis of their answer to the dedicated question asked in the questionnaire.
Measured: Day 1
Evaluate the impact of frequentation of the staff bubble on the occurrence of post-traumatic stress
Difference between the mean PCL scores between the 2 above-mentioned groups
Measured: Day 1
Evaluate the impact of the psychological support unit on the occurrence of anxiety / depressive disorders
Difference between the average HAD scores between the "contact with the psychological support unit" group and the "no contact with the psychological support unit" group. The distinction between the 2 groups is made on the basis of their response to the question asked in the questionnaire.
Measured: Day 1
Evaluate the impact of the psychological support unit on the occurrence of post traumatic stress
Difference between the mean PCL scores between the 2 above-mentioned groups
Measured: Day 1
Evaluate the benefit felt by staff from frequenting the staff bubble
In the group "frequentation of the staff bubble": percentage of response "Very beneficial" or "Quite beneficial"
Measured: Day 1
Evaluate the benefit felt by the staff of the meeting with the psychological support unit
In the group "meeting with the psychological support unit": percentage of response "Very beneficial" or "Quite beneficial"
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start10 Jul 2020
- Primary completion3 Oct 2020
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marguerite D'USSEL, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794920
- Sponsor's protocol ID
- EMOCOV
- Acronym
- EMOCOV
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
d'Ussel M, Fels A, Durand X, Lemogne C, Chatellier G, Castreau N, Adam F. Factors associated with psychological symptoms in hospital workers of a French hospital during the COVID-19 pandemic: Lessons from the first wave. PLoS One. 2022 Apr 28;17(4):e0267032. doi: 10.1371/journal.pone.0267032. eCollection 2022.
PubMed 35482772
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Covid-19 Emotional Aspects of Hospital Staff
- ClinicalTrials.gov ID
- NCT04794920
- Acronym / sponsor ID
- EMOCOV / EMOCOV
- Conditions
- Covid19
- Keywords
- Emotional aspects, caregivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 12 Mar 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 ongoing SARS-CoV2 or Covid-19 pandemic is causing a major global health crisis. In France, it prompted an urgent reorganization of the healthcare supply, mobilizing caregivers and hospital staff in a climate of uncertainty. Health services have been put to the test, some staff being on the front line, others having faced the reorganization of the health system necessitated by such a pandemic.
Frontline caregivers have been compared to "fighters on the front lines." They encountered many difficulties, such as direct exposure to patients with a high viral load, exposure to the risk of contamination, physical exhaustion, reorganization of workspaces, adaptation to rigid work organizations, the management of the shortage of materials, the unusually high number of deaths among patients, colleagues or relatives, ethical questions relating to decision-making in a strained healthcare system.
The psychological impact on these hospital staff is an indirect issue of such a pandemic in terms of mental health.
The investigators have little data in the literature on the incidence of psychiatric episodes in the post-epidemic period. Work on the impact of two major pandemics of influenza A H1N1 (2009) and SARS-CoV-1 (2003) on the mental health of caregivers and other staff working in hospitals reports increased rates of mental disorders after discharge from anxiety-type crisis, depression and post-traumatic stress. This over-representation of mental disorders was still found several years after the epidemic.
Similar results are emerging in recent studies involving hospital staff who were used in the Covid-19 crisis. These highlight a certain number of risk factors for the occurrence of these disorders (young age, nursing profession, underlying psychiatric pathology, exercise carried out in the first line of Covid).
Detailed description
At the Paris Saint-Joseph Hospital Group (GHPSJ), a multidisciplinary working group was early involved in psychological support for staff.
This group proposed the establishment of on-call duty entrusted to a psychological support unit, made up of a doctor, a nurse and a psychologist who volunteered to carry out patrols in the various departments of the hospital. These visits, sometimes organized at the request of the management of the services and sometimes improvised, aimed to identify the difficulties encountered in the field, and to discuss with the teams.
Concomitantly and complementary, the staff bubble opened at the Paris Saint-Joseph Hospital on March 27, to offer a decompression space to all staff (caregivers or not) with proposals for hypnosis, physiotherapy, sophrology sessions. , psychotherapy, but also informal discussions or a break in a relaxing armchair.
As a continuation of this approach, the multidisciplinary working group plans to search in July 2020 for symptoms present in certain mental illnesses (anxiety, depression, post-traumatic stress syndrome) in all the staff of the Paris Saint-Joseph Hospital Group. , now that the crisis seems to be receding. This will make it possible to adapt the support offer for staff in the coming months. This inventory will be made on the basis of validated questionnaires: the Posttraumatic stress disorder CheckList-5 (PCL) questionnaire for post-traumatic stress and the Hospital Anxiety and Depression scale (HAD) score for mental disorders (anxiety, depression) . A 3rd questionnaire will collect additional data and provide feedback on the frequentation of the bubble
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any staff (caregivers and non-carers) who worked during the Covid 19 crisis (from March 15 to May 15) at the GHPSJ, on site or by teleworking, all or part of the period
Key inclusion criteria (1 listed)
- Any staff (caregivers and non-carers) who worked during the Covid 19 crisis (from March 15 to May 15) at the GHPSJ, on site or by teleworking, all or part of the period.
Key exclusion criteria (1 listed)
- Opposition to participate in research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of symptoms related to post-traumatic stress in all staff who worked at the GHPSJ during the crisis (from March 15 to May 15, 2020).
Time frame: Day 1
Rate of staff with a score> 44 on the PCL questionnaire
Frequency of symptoms related to post-traumatic stress in all staff who worked at the GHPSJ during the crisis (from March 15 to May 15, 2020).
Time frame: Day 1
Rate of staff with a score ≥11 on items A and D for the HAD score
7 secondary outcomes
Look for demographic and professional characteristics that may favor the onset of these symptoms
Time frame: Day 1
Evaluate the impact of frequentation of the staff bubble on the occurrence of anxiety / depressive disorders
Time frame: Day 1
Evaluate the impact of frequentation of the staff bubble on the occurrence of post-traumatic stress
Time frame: Day 1
Evaluate the impact of the psychological support unit on the occurrence of anxiety / depressive disorders
Time frame: Day 1
Evaluate the impact of the psychological support unit on the occurrence of post traumatic stress
Time frame: Day 1
Evaluate the benefit felt by staff from frequenting the staff bubble
Time frame: Day 1
Evaluate the benefit felt by the staff of the meeting with the psychological support unit
Time frame: Day 1
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 28 Apr 2023.
- Results publication: PubMed 35482772d'Ussel M, Fels A, Durand X, Lemogne C, Chatellier G, Castreau N, Adam F. Factors associated with psychological symptoms in hospital workers of a French hospital during the COVID-19 pandemic: Lessons from the first wave. PLoS One. 2022 Apr 28;17(4):e0267032. doi: 10.1371/journal.pone.0267032. eCollection 2022.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Marguerite D'USSEL principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Fondation Hôpital Saint-Joseph 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 1 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: finished, as of the sponsor's last update on 28 Apr 2023. 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?
Frequency of symptoms related to post-traumatic stress in all staff who worked at the GHPSJ during the crisis (from March 15 to May 15, 2020). (time frame: Day 1). The study lists 2 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 NCT04794920, which also lists 1 linked publication.
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 28 Apr 2023.