NCT04669054

Brief Summary

The mental health of the French population in response to covid-19 pandemic is of concern. Health professionals are prone to more mental disorders due to their direct exposure to the pandemic consequences. Indeed, compared to general population, health care workers face enormous in the current health situation, especially those who may be in contact with suspected or confirmed cases (risk of infection, inadequate protection, loss of control, lack of experience in managing the diseases, overwork, stigma, lack of support). Thus, it seems interesting to describe the psychological state of hospital interns during this pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

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

December 1, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

December 14, 2020

Last Update Submit

October 22, 2021

Conditions

COVID 19DepressionStress Disorders, Post-Traumatic

Keywords

Hospital interns

Outcome Measures

Primary Outcomes (3)

  • Depressive Symptomatology (PHQ-9)

    evaluation of the participant depressive symptomatology based on the PHQ-9 scale. The PHQ-9 total score ranges from 0 to 27. A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.

    at 5 months (6 months of internship)

  • Depressive Symptomatology (PHQ-9)

    evaluation of the participant depressive symptomatology based on the PHQ-9 scale. The PHQ-9 total score ranges from 0 to 27. A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.

    at inclusion (1 month of internship)

  • Depressive Symptomatology (PHQ-9)

    evaluation of the participant depressive symptomatology based on the PHQ-9 scale. The PHQ-9 total score ranges from 0 to 27. A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.

    at 2 months (3 months of internship)

Secondary Outcomes (33)

  • Sleep evaluation with the Insomnia Severity Index (ISI)

    at inclusion (1 month of internship)

  • Sleep evaluation with the Insomnia Severity Index (ISI)

    at 2 months (3 months of internship)

  • Sleep evaluation with the Insomnia Severity Index (ISI)

    at 5 months (6 months of internship)

  • Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)

    at inclusion (1 month of internship)

  • Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)

    at 2 months (3 months of internship)

  • +28 more secondary outcomes

Eligibility Criteria

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

Occitanie-Est hospital interns

You may qualify if:

  • Being a DES intern (Occitanie-Est)
  • Being on internship as of November 1, 2020

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 Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Emilie Olie, MD PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 16, 2020

Study Start

December 1, 2020

Primary Completion

May 30, 2021

Study Completion

July 30, 2021

Last Updated

October 25, 2021

Record last verified: 2021-10

Locations

FR(1)