Covid19PSY-COEHPAD-OCNCT04916275
Post-traumatic Stress, Signs of Depression and Burnout Syndrome Among Nursing Home Staff in Occitanie During the COVID-19 Pandemic
An observational study of Covid19 and Post Traumatic Stress Disorder, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
Nursing home staff face multiple stresses during the Covid-19 pandemic including personal risk of infection, risk of transmission of the virus to residents and relatives, and risk of witnessing end-of-life scenarios under difficult contexts (absence of families). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Post Traumatic Stress Disorder, Anxiety
- What is being tested?
- Cognitive tests
- How many people
- 501 participants
- Where
- 3 sitesFrance
- Study dates
- 27 May 2021to 11 Oct 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Professionasl working in a nursing home in Occitanie
Who may be able to join
- Professional working in a nursing home in Occitanie
- Professional agreeing to participate
- Professional in a nursing home for at least 3 months
- Professional able to read French
- Profession with an internet connection
Who cannot join
- The subject is in a period of exclusion determined by a previous study
- The subject refuses to participate
- The subject has already been included into the study
- It is impossible to give the subject informed information
- The subject is under safeguard of justice or state guardianship
- The subject is unable to express consent
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Montpellier
Montpellier
CHU de Nîmes, Hôpital Universitaire Carémeau
Nîmes, 30029
CHU de Toulouse
Toulouse
About this study
Official title: Stress Post Traumatique, Signes de dépression et Syndrome d'épuisement Professionnel Chez le Personnel Des EHPAD en Occitanie Pendant la pandémie COVID-19 : étude Prospective
Nursing home staff face multiple stresses during the Covid-19 pandemic including personal risk of infection, risk of transmission of the virus to residents and relatives, and risk of witnessing end-of-life scenarios under difficult contexts (absence of families). The hypothesis of this study is that the Covid-19 period is associated with an incidence of more than 30% of post-traumatic stress in nursing home staff.
- Conditions
- Covid19, Post Traumatic Stress Disorder, Anxiety, Depressive Disorder, Substance Use Disorders
- Being tested
- Cognitive tests
- Medical subject headings
- COVID-19, Stress Disorders, Post-Traumatic, 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.
Cognitive testsOther
Optional tests: Corsi block-tapping task, Stroop test and Iowa gambling task
| Study group | Role | What they receive |
|---|---|---|
| Staff working in a nursing home in Occitanie | Not described Receives: Other: Cognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of post-traumatic stress disorder (PTSD) in the context of the COVID-19 health crisis
Posttraumatic Stress Disorder Checklist Scale (PCL-5) scale, where the recommended cut-off threshold for screening is 44
Measured: Day 0
Secondary outcomes (2)
Prevalence of depression in the context of the COVID-19 health crisis
Hospital Anxiety and Depression Scale (HADS) scale, using a cut-off above 7
Measured: Day 0
Prevalence of burn out in the context of the COVID-19 health crisis
Masslach Burn out Inventory (MBI) questionnaire where high scores for the professional burnout and depersonalization sections and a low score for the personal accomplishments section will signal burn out
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start27 May 2021
- Primary completion11 Oct 2021
- Study completion11 Oct 2021
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.
- 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
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ismaël Conejero, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916275
- Sponsor's protocol ID
- Local/2020/COVID/JYL IC-04
- Other IDs
- 2020-A03541-38
- Acronym
- PSY-COEHPAD-OC
- Status last verified
- Oct 2021
- First submitted
- 4 Jun 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Conejero I, Petrier M, Fabbro Peray P, Voisin C, Courtet P, Potier H, Elotmani L, Lafont B, Lefrant JY, Lopez Castroman J, Arbus C, Blain H. Post-traumatic stress disorder, anxiety, depression and burnout in nursing home staff in South France during the COVID-19 pandemic. Transl Psychiatry. 2023 Jun 15;13(1):205. doi: 10.1038/s41398-023-02488-1.
PubMed 37322006
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Post Traumatique, Signes de dépression et Syndrome d'épuisement Professionnel Chez le Personnel Des EHPAD en Occitanie Pendant la pandémie COVID-19 : étude Prospective
- ClinicalTrials.gov ID
- NCT04916275
- Acronym / sponsor ID
- PSY-COEHPAD-OC / Local/2020/COVID/JYL IC-04
- Conditions
- Covid19, Post Traumatic Stress Disorder, Anxiety, Depressive Disorder, Substance Use Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 7 Jun 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.
Nursing home staff face multiple stresses during the Covid-19 pandemic including personal risk of infection, risk of transmission of the virus to residents and relatives, and risk of witnessing end-of-life scenarios under difficult contexts (absence of families). The hypothesis of this study is that the Covid-19 period is associated with an incidence of more than 30% of post-traumatic stress in nursing home staff.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staff working in a nursing home in Occitanie | – | Other: Cognitive tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Professionasl working in a nursing home in Occitanie
Key inclusion criteria (5 listed)
- Professional working in a nursing home in Occitanie
- Professional agreeing to participate
- Professional in a nursing home for at least 3 months
- Professional able to read French
- Profession with an internet connection
Key exclusion criteria (6 listed)
- The subject is in a period of exclusion determined by a previous study
- The subject refuses to participate
- The subject has already been included into the study
- It is impossible to give the subject informed information
- The subject is under safeguard of justice or state guardianship
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 |
|---|---|---|
| Cognitive testsOptional tests: Corsi block-tapping task, Stroop test and Iowa gambling task | Other | Staff working in a nursing home in Occitanie |
Primary outcome
To assess the prevalence of post-traumatic stress disorder (PTSD) in the context of the COVID-19 health crisis
Time frame: Day 0
Posttraumatic Stress Disorder Checklist Scale (PCL-5) scale, where the recommended cut-off threshold for screening is 44
2 secondary outcomes
Prevalence of depression in the context of the COVID-19 health crisis
Time frame: Day 0
Prevalence of burn out in the context of the COVID-19 health crisis
Time frame: Day 0
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 4 Dec 2025.
- Results publication: PubMed 37322006Conejero I, Petrier M, Fabbro Peray P, Voisin C, Courtet P, Potier H, Elotmani L, Lafont B, Lefrant JY, Lopez Castroman J, Arbus C, Blain H. Post-traumatic stress disorder, anxiety, depression and burnout in nursing home staff in South France during the COVID-19 pandemic. Transl Psychiatry. 2023 Jun 15;13(1):205. doi: 10.1038/s41398-023-02488-1.
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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.
Ismaël Conejero principal investigator
CHU de Nimes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Post Traumatic Stress Disorder, run by Centre Hospitalier Universitaire de Nīmes at 3 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 5 inclusion and 6 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 4 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 3 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?
To assess the prevalence of post-traumatic stress disorder (PTSD) in the context of the COVID-19 health crisis (time frame: Day 0). 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 NCT04916275, 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 4 Dec 2025.