Hospital Interns Psychological State During the COVID-19

Depression Clinical Trial

— RESICOV  

Official title:

Hospital Interns Psychological State During the COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669054
• Other study ID #: RECHMPL20_0665
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

Exclusion criteria:

• Refusal to participate

Related Conditions & MeSH terms

• COVID 19
• COVID-19
• Depression
• Stress Disorders, Post-Traumatic

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	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)
Primary	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)
Primary	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	Sleep evaluation with the Insomnia Severity Index (ISI)	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)
Secondary	Sleep evaluation with the Insomnia Severity Index (ISI)	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)
Secondary	Sleep evaluation with the Insomnia Severity Index (ISI)	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)
Secondary	Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)	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)
Secondary	Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)	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)
Secondary	Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)	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)
Secondary	Psychological pain assessed with visual analogue scale (VAS)	assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).	at inclusion (1 month of internship)
Secondary	Psychological pain assessed with visual analogue scale (VAS)	assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).	at 2 months (3 months of internship)
Secondary	Psychological pain assessed with visual analogue scale (VAS)	assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).	at 5 months (6 months of internship)
Secondary	Physical pain assessed with visual analogue scale (VAS)	assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).	at inclusion (1 month of internship)
Secondary	Physical pain assessed with visual analogue scale (VAS)	assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).	at 2 months (3 months of internship)
Secondary	Physical pain assessed with visual analogue scale (VAS)	assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).	at 5 months (6 months of internship)
Secondary	Suicidal ideation assessed with visual analogue scale (VAS)	assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).	at inclusion (1 month of internship)
Secondary	Suicidal ideation assessed with visual analogue scale (VAS)	assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).	at 2 months (3 months of internship)
Secondary	Suicidal ideation assessed with visual analogue scale (VAS)	assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).	at 5 months (6 months of internship)
Secondary	Anger assessed with the State Anger Expression Inventory (STAXI - state)	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)
Secondary	Anger assessed with the State Anger Expression Inventory (STAXI - state)	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)
Secondary	Anger assessed with the State Anger Expression Inventory (STAXI - state)	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)
Secondary	Stressful Event Impact (Horowitz scale)	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)
Secondary	Stressful Event Impact (Horowitz scale)	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)
Secondary	Stressful Event Impact (Horowitz scale)	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)
Secondary	Psychotropic drugs use	assessement of the psychotropic drugs use increase	at inclusion (1 month of internship)
Secondary	Psychotropic drugs use	assessement of the psychotropic drugs use increase	at 5 months (6 months of internship)
Secondary	Psychotropic drugs use	assessement of the psychotropic drugs use increase	at 2 months (3 months of internship)
Secondary	Tobacco consumption	assessement of the tobacco consumption increase	at 2 months (3 months of internship)
Secondary	Tobacco consumption	assessement of the tobacco consumption increase	at inclusion (1 month of internship)
Secondary	Tobacco consumption	assessement of the tobacco consumption increase	at 5 months (6 months of internship)
Secondary	Alcohol consumption	assessement of the alcohol consumption increase	at 2 months (3 months of internship)
Secondary	Alcohol consumption	assessement of the alcohol consumption increase	at inclusion (1 month of internship)
Secondary	Alcohol consumption	assessement of the alcohol consumption increase	at 5 months (6 months of internship)
Secondary	Illicit substances use	assessement of the illicit substances use increase	at inclusion (1 month of internship)
Secondary	Illicit substances use	assessement of the illicit substances use increase	at 2 months (3 months of internship)
Secondary	Illicit substances use	assessement of the illicit substances use increase	at 5 months (6 months of internship)