RESICOV: Hospital Interns Psychological State During the COVID-19

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04669054
Collaborator
(none)
102
1
7.9
12.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    102 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Hospital Interns Psychological State During the COVID-19 Pandemic
    Actual Study Start Date :
    Dec 1, 2020
    Actual Primary Completion Date :
    May 30, 2021
    Actual Study Completion Date :
    Jul 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Depressive Symptomatology (PHQ-9) [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.

    2. Depressive Symptomatology (PHQ-9) [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.

    3. Depressive Symptomatology (PHQ-9) [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.

    Secondary Outcome Measures

    1. Sleep evaluation with the Insomnia Severity Index (ISI) [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.

    2. Sleep evaluation with the Insomnia Severity Index (ISI) [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.

    3. Sleep evaluation with the Insomnia Severity Index (ISI) [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.

    4. Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7) [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.

    5. Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7) [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.

    6. Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7) [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.

    7. Psychological pain assessed with visual analogue scale (VAS) [at inclusion (1 month of internship)]

      assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).

    8. Psychological pain assessed with visual analogue scale (VAS) [at 2 months (3 months of internship)]

      assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).

    9. Psychological pain assessed with visual analogue scale (VAS) [at 5 months (6 months of internship)]

      assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).

    10. Physical pain assessed with visual analogue scale (VAS) [at inclusion (1 month of internship)]

      assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).

    11. Physical pain assessed with visual analogue scale (VAS) [at 2 months (3 months of internship)]

      assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).

    12. Physical pain assessed with visual analogue scale (VAS) [at 5 months (6 months of internship)]

      assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).

    13. Suicidal ideation assessed with visual analogue scale (VAS) [at inclusion (1 month of internship)]

      assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).

    14. Suicidal ideation assessed with visual analogue scale (VAS) [at 2 months (3 months of internship)]

      assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).

    15. Suicidal ideation assessed with visual analogue scale (VAS) [at 5 months (6 months of internship)]

      assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).

    16. Anger assessed with the State Anger Expression Inventory (STAXI - state) [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.

    17. Anger assessed with the State Anger Expression Inventory (STAXI - state) [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.

    18. Anger assessed with the State Anger Expression Inventory (STAXI - state) [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.

    19. Stressful Event Impact (Horowitz scale) [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

    20. Stressful Event Impact (Horowitz scale) [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

    21. Stressful Event Impact (Horowitz scale) [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

    22. Psychotropic drugs use [at inclusion (1 month of internship)]

      assessement of the psychotropic drugs use increase

    23. Psychotropic drugs use [at 5 months (6 months of internship)]

      assessement of the psychotropic drugs use increase

    24. Psychotropic drugs use [at 2 months (3 months of internship)]

      assessement of the psychotropic drugs use increase

    25. Tobacco consumption [at 2 months (3 months of internship)]

      assessement of the tobacco consumption increase

    26. Tobacco consumption [at inclusion (1 month of internship)]

      assessement of the tobacco consumption increase

    27. Tobacco consumption [at 5 months (6 months of internship)]

      assessement of the tobacco consumption increase

    28. Alcohol consumption [at 2 months (3 months of internship)]

      assessement of the alcohol consumption increase

    29. Alcohol consumption [at inclusion (1 month of internship)]

      assessement of the alcohol consumption increase

    30. Alcohol consumption [at 5 months (6 months of internship)]

      assessement of the alcohol consumption increase

    31. Illicit substances use [at inclusion (1 month of internship)]

      assessement of the illicit substances use increase

    32. Illicit substances use [at 2 months (3 months of internship)]

      assessement of the illicit substances use increase

    33. Illicit substances use [at 5 months (6 months of internship)]

      assessement of the illicit substances use increase

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:
    • Being a DES intern (Occitanie-Est)

    • Being on internship as of November 1, 2020

    Exclusion criteria:
    • Refusal to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04669054
    Other Study ID Numbers:
    • RECHMPL20_0665
    First Posted:
    Dec 16, 2020
    Last Update Posted:
    Oct 25, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 25, 2021