NCT04916275

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2021

Completed
Last Updated

December 4, 2025

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

June 4, 2021

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 0

Secondary Outcomes (2)

  • Prevalence of depression in the context of the COVID-19 health crisis

    Day 0

  • Prevalence of burn out in the context of the COVID-19 health crisis

    Day 0

Other Outcomes (3)

  • Optional assessment of work memory abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression

    Day 0

  • Optional assessment of cognitive flexibility abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression

    Day 0

  • Optional assessment of decision-making abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression

    Day 0

Study Arms (1)

Staff working in a nursing home in Occitanie

Other: Cognitive tests

Interventions

Optional tests: Corsi block-tapping task, Stroop test and Iowa gambling task

Staff working in a nursing home in Occitanie

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Professionasl working in a nursing home in Occitanie

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Montpellier

Montpellier, France

Location

CHU de Nîmes, Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Toulouse

Toulouse, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19Stress Disorders, Post-TraumaticAnxiety DisordersDepressive DisorderSubstance-Related Disorders

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersMood DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Ismaël Conejero

    CHU de Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 7, 2021

Study Start

May 27, 2021

Primary Completion

October 11, 2021

Study Completion

October 11, 2021

Last Updated

December 4, 2025

Record last verified: 2021-10

Locations