- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04669054
Hospital Interns Psychological State During the COVID-19 (RESICOV)
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
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Being a DES intern (Occitanie-Est)
- Being on internship as of November 1, 2020
Exclusion criteria:
- Refusal to participate
Study Plan
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.
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at 5 months (6 months of internship)
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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.
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at inclusion (1 month of internship)
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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.
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at 2 months (3 months of internship)
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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.
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at inclusion (1 month of internship)
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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.
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at 2 months (3 months of internship)
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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.
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at 5 months (6 months of internship)
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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.
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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.
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at 2 months (3 months of internship)
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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).
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at inclusion (1 month of internship)
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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).
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at 2 months (3 months of internship)
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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)
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assessment of the physical pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
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at 5 months (6 months of internship)
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Suicidal ideation assessed with visual analogue scale (VAS)
Time Frame: at inclusion (1 month of internship)
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assessment of the suicidal ideation.
The VAS ranges from 0 (none) to 10 (maximum ideation).
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at inclusion (1 month of internship)
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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).
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at 2 months (3 months of internship)
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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).
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at 5 months (6 months of internship)
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Anger assessed with the State Anger Expression Inventory (STAXI - state)
Time Frame: at 2 months (3 months of internship)
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anger assessment with the STAXI state scale.
The total score ranges from 0 to 50.
The higher the score the higher the anger expression.
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at 2 months (3 months of internship)
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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)
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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.
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at inclusion (1 month of internship)
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Stressful Event Impact (Horowitz scale)
Time Frame: at inclusion (1 month of internship)
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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
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at inclusion (1 month of internship)
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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)
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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
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at 5 months (6 months of internship)
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Psychotropic drugs use
Time Frame: at inclusion (1 month of internship)
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assessement of the psychotropic drugs use increase
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at inclusion (1 month of internship)
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Psychotropic drugs use
Time Frame: at 5 months (6 months of internship)
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assessement of the psychotropic drugs use increase
|
at 5 months (6 months of internship)
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Psychotropic drugs use
Time Frame: at 2 months (3 months of internship)
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assessement of the psychotropic drugs use increase
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at 2 months (3 months of internship)
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Tobacco consumption
Time Frame: at 2 months (3 months of internship)
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assessement of the tobacco consumption increase
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at 2 months (3 months of internship)
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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)
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Alcohol consumption
Time Frame: at 2 months (3 months of internship)
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assessement of the alcohol consumption increase
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at 2 months (3 months of internship)
|
Alcohol consumption
Time Frame: at inclusion (1 month of internship)
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assessement of the alcohol consumption increase
|
at inclusion (1 month of internship)
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Alcohol consumption
Time Frame: at 5 months (6 months of internship)
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assessement of the alcohol consumption increase
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at 5 months (6 months of internship)
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Illicit substances use
Time Frame: at inclusion (1 month of internship)
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assessement of the illicit substances use increase
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at inclusion (1 month of internship)
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Illicit substances use
Time Frame: at 2 months (3 months of internship)
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assessement of the illicit substances use increase
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at 2 months (3 months of internship)
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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
Sponsor
Investigators
- Study Director: Emilie Olie, MD PhD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Trauma and Stressor Related Disorders
- Stress Disorders, Traumatic
- COVID-19
- Stress Disorders, Post-Traumatic
Other Study ID Numbers
- RECHMPL20_0665
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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