Health cAre woRkers exposeD to COVID-19 (HARD-COVID19)

May 9, 2023 updated by: University Hospital, Tours

Symptoms of Depression, Stress and Burnout, and Long-term Psychological Impact in Health Care Professionals Exposed to the Novel Coronavirus Disease 2019 Outbreak (HARD-COVID-19 - Health cAre woRkers exposeD to covID-19)

Health care workers working in hospital or nursing home for elderly people involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion, unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making.

Preliminary data suggests that frontline and lay professionals suffer from different types of psychological distress. These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as Eye Movement Desensitization and Reprocessing (EMDR, desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19.

This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Health care workers working in hospital or nursing home for elderly people involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion, unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making. Preliminary data from China suggests that frontline and lay professionals suffer from different types of psychological distress. A study of the mental health of 230 frontline medical staff in the COVID-19 outbreak found a high prevalence of anxiety and stress disorder (up to 25%).

These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as EMDR (desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19. EMDR is a therapy which for nearly 30 years has demonstrated, through well-conducted international experimental studies with a high level of evidence including a recent meta-analysis from 2019, its effectiveness in the treatment of post-traumatic stress disorder and depression. Its use is recommended by the French National Authority for Health and the World Health Organization. In France, more than 1,700 therapists practice it. While the evidence for the effectiveness of EMDR is strong and its feasibility adapted to a crisis such as the COVID-19 pandemic, its use has not been evaluated at the population level in the context of an exceptional health crisis.

This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).

In addition, this project is also built to allow health professionals involved in the fight against COVID-19 to have regular access to self-administered screening with immediate feedback concerning the most frequent psychological symptoms, this method of screening and monitoring psychological distress in the context of a pandemic is not currently implemented in France.

The objectives of the study are as follows:

  1. / Create a cohort of French hospital health-care workers and French health professionals working in nursing home for elderly people involved in the care of COVID-19 patients in which we will:

    • offer a self-administered mass screening test for common psychiatric disorders likely to occur in this context, and estimate the frequency of occurrence of common psychological symptoms in the short and long term (depression, burnout, post-traumatic stress);
    • estimate the evolution over a year of the aforementioned symptoms and try to explain these trajectories.
  2. / To evaluate, in a randomized controlled trial, the effectiveness of 12 sessions of a specific therapeutic intervention combining "EMDR + usual care" compared to "usual care" alone in eligible participants (those screened positive for psychological symptoms) .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Tours, France, 37044 cedex 9
        • Bretonneau Regional Universitary Hospital
    • Centre Val De Loire
      • Tours, Centre Val De Loire, France, 37044
        • Centre Investigation Clinique 1415

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria in the cohort:

  • ≥ 18 years of age.
  • French speaking.
  • Health care workers: physicians, residents in medicine or pharmacy, dentist residents, nurses, auxiliary nurses, pharmacist, dentist, midwife, physiotherapists, radiographers, ambulance attendants, hospital porters, medical students, pharmacy students, dentist students, midwife students, nursing students, auxiliary nursing students, physiotherapist students, radiographer students.
  • Working in metropolitan French public or private hospitals or in nursing home for elderly people (in French: "Etablissements d'Hébergement pour Personnes Agées Dépendantes" (EHPAD)).
  • Have taken care of patients with COVID-19.
  • Participants covered by or entitled to social security.
  • Written informed consent obtained from the participant.
  • Ability for participant to comply with the requirements of the study.

Inclusion criteria in the EMDR trial:

  • Participant involved in the cohort study.
  • Participant who are screened positive for PTSD (≥ 40 on PCL-5), depression (≥ 15 on PHQ-9), or on one of the burnout dimensions (≤ 22 on compassion satisfaction dimension, ≥ 42 on burnout dimension, or ≥ 42 on compassion fatigue dimension, as measured using the ProQOL) at M0 or M3 or M6.

Exclusion Criteria in the cohort:

  • none

Exclusion criteria in the EMDR trial:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
Subject from this group are screened positive for psychological distress but they will only receive standard of care.
Experimental: Eye Movement Desensitization & Reprocessing Group
Subject from this group are screened positive for psychological distress. They will receive 12 sessions of Eye Movement Desensitization & Reprocessing therapy by a trained therapist over three months in addition to standard of care.
Behavioral: EMDR
The EMDR therapy is organized in eight different phases, requiring attending multiple sessions, usually 12 separate sessions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy on symptoms of Post-Traumatic Stress Disorder
Time Frame: From inclusion to 6 months after inclusion

This study is investigating three different conditions (PTSD, Depression and Burnout) each assessed with its own primary endpoint. Thus, the trial will have three primary endpoints.

Change over a 6 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.
From inclusion to 6 months after inclusion
Efficacy on symptoms of Burnout
Time Frame: From inclusion to 6 months after inclusion
Change over a 6 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.
From inclusion to 6 months after inclusion
Efficacy on symptoms of Depression
Time Frame: From inclusion to 6 months after inclusion
Change over a 6 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.
From inclusion to 6 months after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short-term efficacy on symptoms of PTSD
Time Frame: From inclusion to 3 months after inclusion
Change over a 3 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.
From inclusion to 3 months after inclusion
Short-term efficacy on symptoms of Burnout
Time Frame: From inclusion to 3 months after inclusion
Change over a 3 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.
From inclusion to 3 months after inclusion
Short-term efficacy on symptoms of Depression
Time Frame: From inclusion to 3 months after inclusion
Change over a 3 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.
From inclusion to 3 months after inclusion
Long-term efficacy on symptoms of PTSD
Time Frame: From inclusion to 12 months after inclusion
Change over a 12 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5) for the participants who will be enrolled in the trial at M0 of the cohort. The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.
From inclusion to 12 months after inclusion
Long-term efficacy on symptoms of Burnout
Time Frame: From inclusion to 12 months after inclusion
Change over a 12 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL) for the participants who will be enrolled in the trial at M0 of the cohort. The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.
From inclusion to 12 months after inclusion
Long-term efficacy on symptoms of Depression
Time Frame: From inclusion to 12 months after inclusion
Change over a 12 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9) for the participants who will be enrolled in the trial at M0 of the cohort. The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.
From inclusion to 12 months after inclusion
Efficacy on symptoms of Anxiety
Time Frame: From inclusion to 6 months after inclusion
Change over a 6 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7). The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are.
From inclusion to 6 months after inclusion
Long-term efficacy on symptoms of Anxiety
Time Frame: From inclusion to 12 months after inclusion
Change over a 12 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7) for the participants who will be enrolled in the trial at M0 of the cohort. The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are.
From inclusion to 12 months after inclusion
Efficacy on suicide attempts
Time Frame: From inclusion to 6 months after inclusion
Number of suicide attempts over a 6-month period from baseline
From inclusion to 6 months after inclusion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy on suicidal ideation
Time Frame: From inclusion to 6 months after inclusion
Changes in the level of suicidal ideation over a 6 months period from baseline measured by Visual Analog Scale (VAS). The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is.
From inclusion to 6 months after inclusion
Long-term efficacy on suicidal ideation
Time Frame: From inclusion to 12 months after inclusion
Changes in the level of suicidal ideation over a 12 months period from baseline measured by Visual Analog Scale (VAS) for the participants who are enrolled in the trial at M0 of the cohort. The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is.
From inclusion to 12 months after inclusion
Efficacy on the impact of health on functioning: Role Emotional
Time Frame: From inclusion to 6 months after inclusion
Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is.
From inclusion to 6 months after inclusion
Long-term efficacy on the impact of health on functioning: Role Emotional
Time Frame: From inclusion to 12 months after inclusion
Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is.
From inclusion to 12 months after inclusion
Efficacy on the impact of health on functioning: Role Physical
Time Frame: From inclusion to 6 months after inclusion
Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is.
From inclusion to 6 months after inclusion
Long-term efficacy on the impact of health on functioning: Role Physical
Time Frame: From inclusion to 12 months after inclusion
Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is.
From inclusion to 12 months after inclusion
Substance use
Time Frame: From inclusion to 6 months after inclusion
Evolution of substance use over 6 months
From inclusion to 6 months after inclusion
Long-term substance use
Time Frame: From inclusion to 12 months after inclusion
Evolution of substance use over 12 months for the participants who are enrolled in the trial at M0 of the cohort
From inclusion to 12 months after inclusion
Medication use
Time Frame: From inclusion to 6 months after inclusion
Evolution of medication use over 6 months
From inclusion to 6 months after inclusion
Long-term medication use
Time Frame: From inclusion to 12 months after inclusion
Evolution of medication use over 12 months for the participants who are enrolled in the trial at M0 of the cohort
From inclusion to 12 months after inclusion
Health care utilization
Time Frame: From inclusion to 6 months after inclusion
Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient.
From inclusion to 6 months after inclusion
Long-term health care utilization
Time Frame: From inclusion to 12 months after inclusion
Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient. For the participants who are enrolled in the trial at M0 of the cohort
From inclusion to 12 months after inclusion
Acceptability of EMDR in the EMDR group
Time Frame: From inclusion to 12 months after inclusion
Proportion of those who will be offered EMDR and will actually receive EMDR
From inclusion to 12 months after inclusion
Compliance in the EMDR group
Time Frame: From inclusion to 12 months after inclusion
Number of sessions attended over the total planned number
From inclusion to 12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Wissam EL-HAGE, MD-PhD, University hospital of Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DR200160-HARD-COVID-19
  • 2020-A01642-37 (Registry Identifier: ID-RCB)
  • 1-20-046 ID 48680 (Other Identifier: CPP SOOM-1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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