Hospital Interns Psychological State During the COVID-19 (RESICOV)

October 22, 2021 updated by: University Hospital, Montpellier

Hospital Interns Psychological State During the COVID-19 Pandemic

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

102

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, 34295
        • University Hospital

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Occitanie-Est hospital interns

Description

Inclusion criteria:

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

Exclusion criteria:

- Refusal to participate

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptomatology (PHQ-9)
Time Frame: at 5 months (6 months of internship)
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)
Time Frame: at inclusion (1 month of internship)
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)
Time Frame: at 2 months (3 months of internship)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep evaluation with the Insomnia Severity Index (ISI)
Time Frame: at inclusion (1 month of internship)
sleep quality evaluation based on the ISI score. The ISI total score ranges from 0 to 28. A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.
at inclusion (1 month of internship)
Sleep evaluation with the Insomnia Severity Index (ISI)
Time Frame: at 2 months (3 months of internship)
sleep quality evaluation based on the ISI score. The ISI total score ranges from 0 to 28. A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.
at 2 months (3 months of internship)
Sleep evaluation with the Insomnia Severity Index (ISI)
Time Frame: at 5 months (6 months of internship)
sleep quality evaluation based on the ISI score. The ISI total score ranges from 0 to 28. A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.
at 5 months (6 months of internship)
Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)
Time Frame: at inclusion (1 month of internship)
anxiety evaluation based on the GAD-7 score. The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
at inclusion (1 month of internship)
Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)
Time Frame: at 2 months (3 months of internship)
anxiety evaluation based on the GAD-7 score. The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
at 2 months (3 months of internship)
Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)
Time Frame: at 5 months (6 months of internship)
anxiety evaluation based on the GAD-7 score. The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
at 5 months (6 months of internship)
Psychological pain assessed with visual analogue scale (VAS)
Time Frame: at inclusion (1 month of internship)
assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).
at inclusion (1 month of internship)
Psychological pain assessed with visual analogue scale (VAS)
Time Frame: at 2 months (3 months of internship)
assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).
at 2 months (3 months of internship)
Psychological pain assessed with visual analogue scale (VAS)
Time Frame: at 5 months (6 months of internship)
assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).
at 5 months (6 months of internship)
Physical pain assessed with visual analogue scale (VAS)
Time Frame: at inclusion (1 month of internship)
assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).
at inclusion (1 month of internship)
Physical pain assessed with visual analogue scale (VAS)
Time Frame: at 2 months (3 months of internship)
assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).
at 2 months (3 months of internship)
Physical pain assessed with visual analogue scale (VAS)
Time Frame: at 5 months (6 months of internship)
assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).
at 5 months (6 months of internship)
Suicidal ideation assessed with visual analogue scale (VAS)
Time Frame: at inclusion (1 month of internship)
assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).
at inclusion (1 month of internship)
Suicidal ideation assessed with visual analogue scale (VAS)
Time Frame: at 2 months (3 months of internship)
assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).
at 2 months (3 months of internship)
Suicidal ideation assessed with visual analogue scale (VAS)
Time Frame: at 5 months (6 months of internship)
assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).
at 5 months (6 months of internship)
Anger assessed with the State Anger Expression Inventory (STAXI - state)
Time Frame: at 2 months (3 months of internship)
anger assessment with the STAXI state scale. The total score ranges from 0 to 50. The higher the score the higher the anger expression.
at 2 months (3 months of internship)
Anger assessed with the State Anger Expression Inventory (STAXI - state)
Time Frame: at 5 months (6 months of internship)
anger assessment with the STAXI state scale. The total score ranges from 0 to 50. The higher the score the higher the anger expression.
at 5 months (6 months of internship)
Anger assessed with the State Anger Expression Inventory (STAXI - state)
Time Frame: at inclusion (1 month of internship)
anger assessment with the STAXI state scale. The total score ranges from 0 to 50. The higher the score the higher the anger expression.
at inclusion (1 month of internship)
Stressful Event Impact (Horowitz scale)
Time Frame: at inclusion (1 month of internship)
assessement of stressful event impact with the Horowitz scale. The total score ranges from 0 to 45. The higher the score the higher the trauma
at inclusion (1 month of internship)
Stressful Event Impact (Horowitz scale)
Time Frame: at 2 months (3 months of internship)
assessement of stressful event impact with the Horowitz scale. The total score ranges from 0 to 45. The higher the score the higher the trauma
at 2 months (3 months of internship)
Stressful Event Impact (Horowitz scale)
Time Frame: at 5 months (6 months of internship)
assessement of stressful event impact with the Horowitz scale. The total score ranges from 0 to 45. The higher the score the higher the trauma
at 5 months (6 months of internship)
Psychotropic drugs use
Time Frame: at inclusion (1 month of internship)
assessement of the psychotropic drugs use increase
at inclusion (1 month of internship)
Psychotropic drugs use
Time Frame: at 5 months (6 months of internship)
assessement of the psychotropic drugs use increase
at 5 months (6 months of internship)
Psychotropic drugs use
Time Frame: at 2 months (3 months of internship)
assessement of the psychotropic drugs use increase
at 2 months (3 months of internship)
Tobacco consumption
Time Frame: at 2 months (3 months of internship)
assessement of the tobacco consumption increase
at 2 months (3 months of internship)
Tobacco consumption
Time Frame: at inclusion (1 month of internship)
assessement of the tobacco consumption increase
at inclusion (1 month of internship)
Tobacco consumption
Time Frame: at 5 months (6 months of internship)
assessement of the tobacco consumption increase
at 5 months (6 months of internship)
Alcohol consumption
Time Frame: at 2 months (3 months of internship)
assessement of the alcohol consumption increase
at 2 months (3 months of internship)
Alcohol consumption
Time Frame: at inclusion (1 month of internship)
assessement of the alcohol consumption increase
at inclusion (1 month of internship)
Alcohol consumption
Time Frame: at 5 months (6 months of internship)
assessement of the alcohol consumption increase
at 5 months (6 months of internship)
Illicit substances use
Time Frame: at inclusion (1 month of internship)
assessement of the illicit substances use increase
at inclusion (1 month of internship)
Illicit substances use
Time Frame: at 2 months (3 months of internship)
assessement of the illicit substances use increase
at 2 months (3 months of internship)
Illicit substances use
Time Frame: at 5 months (6 months of internship)
assessement of the illicit substances use increase
at 5 months (6 months of internship)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Emilie Olie, MD PhD, University Hospital, Montpellier

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)

December 1, 2020

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

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.

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