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Completed

NCT Number: NCT04669054

Hospital Interns Psychological State During the COVID-19

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.

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Key information

Conditions

COVID 19 Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Depression Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal to participate

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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

  21. 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

  22. Psychotropic drugs use

    Time frame: at inclusion (1 month of internship)

    assessement of the psychotropic drugs use increase

  23. Psychotropic drugs use

    Time frame: at 5 months (6 months of internship)

    assessement of the psychotropic drugs use increase

  24. Psychotropic drugs use

    Time frame: at 2 months (3 months of internship)

    assessement of the psychotropic drugs use increase

  25. Tobacco consumption

    Time frame: at 2 months (3 months of internship)

    assessement of the tobacco consumption increase

  26. Tobacco consumption

    Time frame: at inclusion (1 month of internship)

    assessement of the tobacco consumption increase

  27. Tobacco consumption

    Time frame: at 5 months (6 months of internship)

    assessement of the tobacco consumption increase

  28. Alcohol consumption

    Time frame: at 2 months (3 months of internship)

    assessement of the alcohol consumption increase

  29. Alcohol consumption

    Time frame: at inclusion (1 month of internship)

    assessement of the alcohol consumption increase

  30. Alcohol consumption

    Time frame: at 5 months (6 months of internship)

    assessement of the alcohol consumption increase

  31. Illicit substances use

    Time frame: at inclusion (1 month of internship)

    assessement of the illicit substances use increase

  32. Illicit substances use

    Time frame: at 2 months (3 months of internship)

    assessement of the illicit substances use increase

  33. Illicit substances use

    Time frame: at 5 months (6 months of internship)

    assessement of the illicit substances use increase

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Hospital Interns Psychological State During the COVID-19 Pandemic

Acronym: RESICOV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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