COVID 19RESICOVNCT04669054
Hospital Interns Psychological State During the COVID-19
An observational study of COVID 19 and Depression, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID 19, Depression, Stress Disorders, Post-Traumatic
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Occitanie-Est hospital interns
Who may be able to join
- Being a DES intern (Occitanie-Est)
- Being on internship as of November 1, 2020
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID 19, Depression, Stress Disorders, Post-Traumatic
- Keywords
- Hospital interns
- Medical subject headings
- COVID-19, Depression, Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 5 months (6 months of internship)
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.
Measured: at inclusion (1 month of internship)
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.
Measured: at 2 months (3 months of internship)
Secondary outcomes (33)
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.
Measured: at inclusion (1 month of internship)
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.
Measured: at 2 months (3 months of internship)
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.
Measured: at 5 months (6 months of internship)
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.
Measured: at inclusion (1 month of internship)
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.
Measured: at 2 months (3 months of internship)
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.
Measured: at 5 months (6 months of internship)
Psychological pain assessed with visual analogue scale (VAS)
assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).
Measured: at inclusion (1 month of internship)
Psychological pain assessed with visual analogue scale (VAS)
assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).
Measured: at 2 months (3 months of internship)
Psychological pain assessed with visual analogue scale (VAS)
assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).
Measured: at 5 months (6 months of internship)
Physical pain assessed with visual analogue scale (VAS)
assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).
Measured: at inclusion (1 month of internship)
Physical pain assessed with visual analogue scale (VAS)
assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).
Measured: at 2 months (3 months of internship)
Physical pain assessed with visual analogue scale (VAS)
assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).
Measured: at 5 months (6 months of internship)
Suicidal ideation assessed with visual analogue scale (VAS)
assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).
Measured: at inclusion (1 month of internship)
Suicidal ideation assessed with visual analogue scale (VAS)
assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).
Measured: at 2 months (3 months of internship)
Suicidal ideation assessed with visual analogue scale (VAS)
assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).
Measured: at 5 months (6 months of internship)
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.
Measured: at 2 months (3 months of internship)
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.
Measured: at 5 months (6 months of internship)
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.
Measured: at inclusion (1 month of internship)
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
Measured: at inclusion (1 month of internship)
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
Measured: at 2 months (3 months of internship)
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
Measured: at 5 months (6 months of internship)
Psychotropic drugs use
assessement of the psychotropic drugs use increase
Measured: at inclusion (1 month of internship)
Psychotropic drugs use
assessement of the psychotropic drugs use increase
Measured: at 5 months (6 months of internship)
Psychotropic drugs use
assessement of the psychotropic drugs use increase
Measured: at 2 months (3 months of internship)
Tobacco consumption
assessement of the tobacco consumption increase
Measured: at 2 months (3 months of internship)
Tobacco consumption
assessement of the tobacco consumption increase
Measured: at inclusion (1 month of internship)
Tobacco consumption
assessement of the tobacco consumption increase
Measured: at 5 months (6 months of internship)
Alcohol consumption
assessement of the alcohol consumption increase
Measured: at 2 months (3 months of internship)
Alcohol consumption
assessement of the alcohol consumption increase
Measured: at inclusion (1 month of internship)
Alcohol consumption
assessement of the alcohol consumption increase
Measured: at 5 months (6 months of internship)
Illicit substances use
assessement of the illicit substances use increase
Measured: at inclusion (1 month of internship)
Illicit substances use
assessement of the illicit substances use increase
Measured: at 2 months (3 months of internship)
Illicit substances use
assessement of the illicit substances use increase
Measured: at 5 months (6 months of internship)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Dec 2020
- Primary completion30 May 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Olie, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669054
- Sponsor's protocol ID
- RECHMPL20_0665
- Acronym
- RESICOV
- Status last verified
- Oct 2021
- First submitted
- 14 Dec 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Interns Psychological State During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04669054
- Acronym / sponsor ID
- RESICOV / RECHMPL20_0665
- Conditions
- COVID 19, Depression, Stress Disorders, Post-Traumatic
- Keywords
- Hospital interns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Occitanie-Est hospital interns
Key inclusion criteria (2 listed)
- Being a DES intern (Occitanie-Est)
- Being on internship as of November 1, 2020
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
33 secondary outcomes
Sleep evaluation with the Insomnia Severity Index (ISI)
Time frame: at inclusion (1 month of internship)
Sleep evaluation with the Insomnia Severity Index (ISI)
Time frame: at 2 months (3 months of internship)
Sleep evaluation with the Insomnia Severity Index (ISI)
Time frame: 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 with the Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: 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)
Psychological pain assessed with visual analogue scale (VAS)
Time frame: at inclusion (1 month of internship)
Psychological pain assessed with visual analogue scale (VAS)
Time frame: at 2 months (3 months of internship)
Psychological pain assessed with visual analogue scale (VAS)
Time frame: at 5 months (6 months of internship)
Physical pain assessed with visual analogue scale (VAS)
Time frame: at inclusion (1 month of internship)
Physical pain assessed with visual analogue scale (VAS)
Time frame: at 2 months (3 months of internship)
Physical pain assessed with visual analogue scale (VAS)
Time frame: at 5 months (6 months of internship)
Suicidal ideation assessed with visual analogue scale (VAS)
Time frame: at inclusion (1 month of internship)
Suicidal ideation assessed with visual analogue scale (VAS)
Time frame: at 2 months (3 months of internship)
Suicidal ideation assessed with visual analogue scale (VAS)
Time frame: 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 assessed with the State Anger Expression Inventory (STAXI - state)
Time frame: 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)
Stressful Event Impact (Horowitz scale)
Time frame: at inclusion (1 month of internship)
Stressful Event Impact (Horowitz scale)
Time frame: at 2 months (3 months of internship)
Stressful Event Impact (Horowitz scale)
Time frame: at 5 months (6 months of internship)
Psychotropic drugs use
Time frame: at inclusion (1 month of internship)
Psychotropic drugs use
Time frame: at 5 months (6 months of internship)
Psychotropic drugs use
Time frame: at 2 months (3 months of internship)
Tobacco consumption
Time frame: at 2 months (3 months of internship)
Tobacco consumption
Time frame: at inclusion (1 month of internship)
Tobacco consumption
Time frame: at 5 months (6 months of internship)
Alcohol consumption
Time frame: at 2 months (3 months of internship)
Alcohol consumption
Time frame: at inclusion (1 month of internship)
Alcohol consumption
Time frame: at 5 months (6 months of internship)
Illicit substances use
Time frame: at inclusion (1 month of internship)
Illicit substances use
Time frame: at 2 months (3 months of internship)
Illicit substances use
Time frame: at 5 months (6 months of internship)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Olie, MD PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID 19 and Depression, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptomatology (PHQ-9) (time frame: at 5 months (6 months of internship)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.