NCT05037214

Brief Summary

As of December 2019, the global pandemic of COVID-19 has spread rapidly throughout the world, putting healthcare staff at the frontline. In this context, several factors leading to the appearance of psychiatric symptoms have emerged : work overload, fear of being infected or of infecting, exhaustion… (The Lancet, 2020) Indeed, post-traumatic stress disorder (PTSD), depressive symptoms, anxiety symptoms, insomnia and increased stress have been reported (Rossi et al., 2020). Furthermore, the increased anxiety and depression symptoms and stress associated with the COVID-19 pandemic may increase the risk of suicide in this already high-risk population. For example, suicidal ideation has been reported in up to 5% of healthcare workers in the United States (Young et al., 2021). It is therefore essential to evaluate the incidence of psychiatric disorders (e.g. PTSD, depression, suicide) and their associated risk factors among the hospital staff. To do so, Montpellier University Hospital healthcare staff was asked their mental state during the first wave of COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
779

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

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

June 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

September 6, 2021

Last Update Submit

September 6, 2021

Conditions

Keywords

PsychiatryHealthcare staff

Outcome Measures

Primary Outcomes (3)

  • Anxiety symptoms

    anxiety level assessed with the Generalized Anxiety Disorder questionnaire (GAD-7) : higher score indicates higher anxiety (min : 0; max : 21)

    day 1

  • Depression symptoms

    depression symptomatoloy assessed with the Patient Health Questionnaire (PHQ-9) : higher score indicates higher depression level (min : 0; max : 27)

    day 1

  • Sleep

    sleep quality assessed with the Insomnia Severity Index (ISI) : higher score indicates higher insomnia level (min : 0; max : 28)

    day 1

Secondary Outcomes (3)

  • Post traumatic stress disorder

    day 1

  • Physical pain

    day 1

  • Burnout symptoms

    day 1

Eligibility Criteria

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

Healthcare staff working during the first wave of COVID-19

You may qualify if:

  • Healthcare staff working at Montpellier University Hospital during the first wave of COVID-19
  • Having responded to the online survey sent to all healthcare staff

You may not qualify if:

  • \- Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

COVID-19DepressionStress, PsychologicalBurnout, Psychological

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehavior

Study Officials

  • Bénédicte NOBILE, PharmD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 8, 2021

Study Start

June 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations