Critical IllnessPSY-CO-ICUNCT04511780
Psychological Impact of COVID-19 Outbreak on Caregivers
An observational study of Critical Illness and Covid19, run by Centre Hospitalier Universitaire de Nīmes at 51 sites in France.
Trial summary
Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Covid19, Stress Disorders, Post-Traumatic
- What is being tested?
- questionnaire filling
- How many people
- 701 participants
- Where
- 51 sitesFrance
- Study dates
- 25 Feb 2021to 20 Jul 2022
- 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: Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak
Who may be able to join
- Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak
- Approved to participate
Who cannot join
- Participation refusal
- No internet connection for responding to the questionnaire with REDCAP file
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
France51 sites
Intensive Care Unit, CHU d'Amiens
Amiens, 80054
Intensive Care Unit, CHU d'Angers
Angers, 49933
CHU de Besançon
Besançon, 25030
CHU de Bordeaux, Hôpital Pellegrin
Bordeaux, 33076
Intensive care Unit CHU de Brest Hôpital Cavale Blanche
Brest, 29609
CHU de Caen
Caen, 14033
CHU de Clermont Ferrand
Clermont-Ferrand, 63003
AP-HP, Hôpital Henri Mondor
Créteil, 94010
CHU de dijon
Dijon, 21079
CHU de Grenoble, Hôpital Michalon
La Tronche, 38700
AP_HP, Hôpital du Kremlin Bicêtre
Le Kremlin-Bicêtre, 94275
Intensive Care Unit, CHRU de Lille
Lille, 59037
Intensive Care Unit, CHU de Limoges
Limoges, 87042
Hôpitaux civils de Lyon, Hôpital de la Croix Rousse
Lyon, 69317
Hôpitaux civils de Lyon, Hôpital Louis Pradel
Lyon, 69394
Hôpitaux civils de Lyon, Hôpital Edouard Herriot
Lyon, 69437
AP-HM, Hôpital Nord
Marseille, 13005
AP-HM, Hôpital Timone adultes, Intensive Care Unit
Marseille, 13005
AP-HM, Hôpital Timone adultes, Neurotraumatology
Marseille, 13015
AP-HM, Hôpital e la Conception
Marseille, 13385
CHU de Montpellier, Hôpital Guy de chauliac
Montpellier, 34295
CHU de Montpellier, Hôpital Lapeyronie
Montpellier, 34295
CHU de Montpellier, Hôpital St Eloi SAR B
Montpellier, 34295
CHU De Montpellier, Hôpital St Eloi-DAR B
Montpellier, 34295
CHU De Montpellier, Hôpital St Eloi
Montpellier, 34295
Intensive Care Unit, CHU de Mulhouse
Mulhouse, 68051
Intensive CAre Unit CHRU de Nancy, Hôpital Central
Nancy, 54000
Intensive Care Unit, CHU de Nantes, Hôtel Dieu
Nantes, 44093
Intensive Care Unit, CHU de Nantes
Nantes, 44093
CHU de Nice
Nice, 06000
Intensive care Unit CHU Nîmes
Nîmes, 30029
AP-HP, Hôpital de la Pitié
Paris, 75013
AP-HP, Hôpital Bichât
Paris, 75018
AP-HP, Hôpital Lariboisière
Paris, 75475
AP6HP, Hôpital St Loui
Paris, 75475
AP_HP, Hôpital G Pompidou
Paris, 75908
AP-HP, Hôpital St Antoine
Paris, 75970
CH de Perpignan
Perpignan, 66046
CHU de Bordeaux, Hôpital Haut Leveque
Pessac, 33604
Intensive care Unit, Hôpitaux civils de Lyon, Lyon Sud
Pierre-Bénite, 69310
CHU de Poitiers
Poitiers, 86021
Intensive care Unit CHU de Rennes
Rennes, 35033
CHU de Rouen
Rouen, 76031
CHU de St Etienne, Hôpital Nord
Saint-Etienne, 42055
Intensive Care Unit, CHU de Nantes, Hôpital Laennec
Saint-Herblain, 44800
Intesive Care Unit CHRU de Strasbourg, Hôpital civil
Strasbourg, 67091
Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre
Strasbourg, 67098
CHU de Toulouse
Toulouse, 31059
Intensive care unit CHU de Tours
Tours, 37044
Intensive CAre Unit CHRU de Nancy, Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511
CH de Vesoul
Vesoul, 70014
About this study
Official title: Psychological Impact of COVID-19 Outbreak on Caregivers Involved in Intensive Care Unit Patient Management: Impact on the Occurrence of Post-traumatic Stress Disorder, Anxiety, Depression and Burn Out Syndrome
Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means:
- For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs.
- For the less severe patients, personals of non-busy units have been transferred in busier ones.
Read more
All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms.
In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.
- Conditions
- Critical Illness, Covid19, Stress Disorders, Post-Traumatic
- Being tested
- questionnaire filling
- Medical subject headings
- Critical Illness, COVID-19, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire fillingOther
assessment of post-traumatic stress, anxiety and burn out
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | • Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak Receives: Other: questionnaire filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Stress Disorder
PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)
Measured: 3-6 month after the Covid-19 outbreak
Secondary outcomes (2)
anxiety and depression
HADS scale (Hospital Anxiety and Depression Scale)
Measured: 3-6 month after the Covid-19 outbreak
Burn out
Score MBI (Burn out syndrome)
Measured: 3-6 month after the Covid-19 outbreak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start25 Feb 2021
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
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 Critical IllnessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Yves LEFRANT, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511780
- Sponsor's protocol ID
- Local/2020/JYL-03
- Acronym
- PSY-CO-ICU
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2020
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roger C, Ling L, Petrier M, Elotmani L, Atchade E, Allaouchiche B, Aubrun F, Constantin JM, Dahyot-Fizelier C, Delhaye N, Dupont H, Fischer MO, Garnier M, Gayat E, Ichai C, Jaber S, Morel J, Plaud B, Rimmele T, Robin S, Saba R, Joynt GM, Lefrant JY, Fabbro-Peray P, Lipman J, Conejero I, Laupland K. Occurrences of post-traumatic stress disorder, anxiety, depression, and burnout syndrome in ICU staff workers after two-year of the COVID-19 pandemic: the international PSY-CO in ICU study. Ann Gen Psychiatry. 2024 Jan 3;23(1):3. doi: 10.1186/s12991-023-00488-5.
PubMed 38172994
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of COVID-19 Outbreak on Caregivers Involved in Intensive Care Unit Patient Management: Impact on the Occurrence of Post-traumatic Stress Disorder, Anxiety, Depression and Burn Out Syndrome
- ClinicalTrials.gov ID
- NCT04511780
- Acronym / sponsor ID
- PSY-CO-ICU / Local/2020/JYL-03
- Conditions
- Critical Illness, Covid19, Stress Disorders, Post-Traumatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 13 Aug 2020 (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.
Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means:
- For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs.
- For the less severe patients, personals of non-busy units have been transferred in busier ones.
All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms.
In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Other: questionnaire filling• Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak
Key inclusion criteria (2 listed)
- Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak
- Approved to participate
Key exclusion criteria (2 listed)
- Participation refusal
- No internet connection for responding to the questionnaire with REDCAP file
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 |
|---|---|---|
| questionnaire fillingassessment of post-traumatic stress, anxiety and burn out | Other | Caregivers |
Primary outcome
Post-Traumatic Stress Disorder
Time frame: 3-6 month after the Covid-19 outbreak
PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)
2 secondary outcomes
anxiety and depression
Time frame: 3-6 month after the Covid-19 outbreak
Burn out
Time frame: 3-6 month after the Covid-19 outbreak
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 10 Dec 2025.
- Results publication: PubMed 38172994Roger C, Ling L, Petrier M, Elotmani L, Atchade E, Allaouchiche B, Aubrun F, Constantin JM, Dahyot-Fizelier C, Delhaye N, Dupont H, Fischer MO, Garnier M, Gayat E, Ichai C, Jaber S, Morel J, Plaud B, Rimmele T, Robin S, Saba R, Joynt GM, Lefrant JY, Fabbro-Peray P, Lipman J, Conejero I, Laupland K. Occurrences of post-traumatic stress disorder, anxiety, depression, and burnout syndrome in ICU staff workers after two-year of the COVID-19 pandemic: the international PSY-CO in ICU study. Ann Gen Psychiatry. 2024 Jan 3;23(1):3. doi: 10.1186/s12991-023-00488-5.
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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.
Jean Yves LEFRANT principal investigator
Centre Hospitalier Universitaire de Nīmes
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Covid19, run by Centre Hospitalier Universitaire de Nīmes at 51 sites 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 2 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites 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?
Post-Traumatic Stress Disorder (time frame: 3-6 month after the Covid-19 outbreak). 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 NCT04511780, 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 10 Dec 2025.