- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04916275
Post-traumatic Stress, Signs of Depression and Burnout Syndrome Among Nursing Home Staff in Occitanie During the COVID-19 Pandemic (PSY-COEHPAD-OC)
November 26, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
501
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France
- CHU de Montpellier
-
Nîmes, France, 30029
- CHU de Nîmes, Hôpital Universitaire Carémeau
-
Toulouse, France
- CHU de Toulouse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Professionasl working in a nursing home in Occitanie
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Staff working in a nursing home in Occitanie
|
Optional tests: Corsi block-tapping task, Stroop test and Iowa gambling task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of depression in the context of the COVID-19 health crisis
Time Frame: Day 0
|
Hospital Anxiety and Depression Scale (HADS) scale, using a cut-off above 7
|
Day 0
|
|
Prevalence of burn out in the context of the COVID-19 health crisis
Time Frame: Day 0
|
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
|
Day 0
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optional assessment of work memory abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression
Time Frame: Day 0
|
Corsi block-tapping task - score ranging from 0(good memory) -18(bad memory)
|
Day 0
|
|
Optional assessment of cognitive flexibility abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression
Time Frame: Day 0
|
Corsi block-tapping task - score ranging from 0(good memory) -18(bad memory)
|
Day 0
|
|
Optional assessment of decision-making abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression
Time Frame: Day 0
|
Iowa Gambling Task - score ranes from -14 to +40
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ismaël Conejero, CHU de Nîmes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2021
Primary Completion (Actual)
October 11, 2021
Study Completion (Actual)
October 11, 2021
Study Registration Dates
First Submitted
June 4, 2021
First Submitted That Met QC Criteria
June 4, 2021
First Posted (Actual)
June 7, 2021
Study Record Updates
Last Update Posted (Estimated)
December 4, 2025
Last Update Submitted That Met QC Criteria
November 26, 2025
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Mental Disorders
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Chemically-Induced Disorders
- Mood Disorders
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Stress Disorders, Traumatic
- COVID-19
- Anxiety Disorders
- Depressive Disorder
- Substance-Related Disorders
- Stress Disorders, Post-Traumatic
- Behavioral Disciplines and Activities
- Psychological Tests
- Neuropsychological Tests
Other Study ID Numbers
- Local/2020/COVID/JYL IC-04
- 2020-A03541-38 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.