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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05037214
Other study ID # RECHMPL21_0548
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date June 30, 2021

Study information

Verified date September 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 779
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - 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 Exclusion criteria: - Refusal to participate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France University hospital Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety symptoms anxiety level assessed with the Generalized Anxiety Disorder questionnaire (GAD-7) : higher score indicates higher anxiety (min : 0; max : 21) day 1
Primary Depression symptoms depression symptomatoloy assessed with the Patient Health Questionnaire (PHQ-9) : higher score indicates higher depression level (min : 0; max : 27) day 1
Primary Sleep sleep quality assessed with the Insomnia Severity Index (ISI) : higher score indicates higher insomnia level (min : 0; max : 28) day 1
Secondary Post traumatic stress disorder post traumatic stress disorder symptomatology assessed with the Posttraumatic stress disorder Checklist Scale (PCL-S) : higher score indicates more sever post traumatic stress disorder symptoms day 1
Secondary Physical pain physical pain assessed with a likert scale day 1
Secondary Burnout symptoms burnout symptomatology assessed with the Maslach Burnout Inventory (MBI) : higher scores on the emotional exhaustion scale and the depersonalization scale and lower score on the professional accomplishment scale indicate higher burnout level. day 1
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