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

Primary Purpose

Depression, Burnout, Professional, Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EMDR
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Covid-19 pandemic, Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2), Healthcare Professionals, Psychological Distress, Post-Traumatic Stress Disorder, Burnout, Depression, Eye Movement Desensitization & Reprocessing, Randomized Controlled Trial, Cohort, Trials Within Cohort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Investigation Clinique 1415
  • Bretonneau Regional Universitary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Eye Movement Desensitization & Reprocessing Group

Arm Description

Subject from this group are screened positive for psychological distress but they will only receive standard of care.

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.

Outcomes

Primary Outcome Measures

Efficacy on symptoms of Post-Traumatic Stress Disorder
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.
Efficacy on symptoms of Burnout
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.
Efficacy on symptoms of Depression
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.

Secondary Outcome Measures

Short-term efficacy on symptoms of PTSD
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.
Short-term efficacy on symptoms of Burnout
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.
Short-term efficacy on symptoms of Depression
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.
Long-term efficacy on symptoms of PTSD
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.
Long-term efficacy on symptoms of Burnout
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.
Long-term efficacy on symptoms of Depression
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.
Efficacy on symptoms of Anxiety
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.
Long-term efficacy on symptoms of Anxiety
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.
Efficacy on suicide attempts
Number of suicide attempts over a 6-month period from baseline

Full Information

First Posted
September 28, 2020
Last Updated
May 9, 2023
Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04570202
Brief Title
Health cAre woRkers exposeD to COVID-19
Acronym
HARD-COVID19
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
July 17, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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: / 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. / 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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Burnout, Professional, Post Traumatic Stress Disorder
Keywords
Covid-19 pandemic, Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2), Healthcare Professionals, Psychological Distress, Post-Traumatic Stress Disorder, Burnout, Depression, Eye Movement Desensitization & Reprocessing, Randomized Controlled Trial, Cohort, Trials Within Cohort

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Trials Within Cohort (TWIC) : Participants are included within a cohort. They are screened using an online self-administered questionnaire for psychological distress (Post-Traumatic Stress Disorder, Burnout, Depression) every three months for one year. People who are positive after screening (at M0 or M3 or M6) will be eligible for the trial and some of them will be randomly assigned to the treatment group. The rest of the cohort will be the second arm (control group).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Subject from this group are screened positive for psychological distress but they will only receive standard of care.
Arm Title
Eye Movement Desensitization & Reprocessing Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EMDR
Intervention Description
The EMDR therapy is organized in eight different phases, requiring attending multiple sessions, usually 12 separate sessions.
Primary Outcome Measure Information:
Title
Efficacy on symptoms of Post-Traumatic Stress Disorder
Description
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.
Time Frame
From inclusion to 6 months after inclusion
Title
Efficacy on symptoms of Burnout
Description
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.
Time Frame
From inclusion to 6 months after inclusion
Title
Efficacy on symptoms of Depression
Description
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.
Time Frame
From inclusion to 6 months after inclusion
Secondary Outcome Measure Information:
Title
Short-term efficacy on symptoms of PTSD
Description
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.
Time Frame
From inclusion to 3 months after inclusion
Title
Short-term efficacy on symptoms of Burnout
Description
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.
Time Frame
From inclusion to 3 months after inclusion
Title
Short-term efficacy on symptoms of Depression
Description
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.
Time Frame
From inclusion to 3 months after inclusion
Title
Long-term efficacy on symptoms of PTSD
Description
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.
Time Frame
From inclusion to 12 months after inclusion
Title
Long-term efficacy on symptoms of Burnout
Description
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.
Time Frame
From inclusion to 12 months after inclusion
Title
Long-term efficacy on symptoms of Depression
Description
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.
Time Frame
From inclusion to 12 months after inclusion
Title
Efficacy on symptoms of Anxiety
Description
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.
Time Frame
From inclusion to 6 months after inclusion
Title
Long-term efficacy on symptoms of Anxiety
Description
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.
Time Frame
From inclusion to 12 months after inclusion
Title
Efficacy on suicide attempts
Description
Number of suicide attempts over a 6-month period from baseline
Time Frame
From inclusion to 6 months after inclusion
Other Pre-specified Outcome Measures:
Title
Efficacy on suicidal ideation
Description
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.
Time Frame
From inclusion to 6 months after inclusion
Title
Long-term efficacy on suicidal ideation
Description
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.
Time Frame
From inclusion to 12 months after inclusion
Title
Efficacy on the impact of health on functioning: Role Emotional
Description
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.
Time Frame
From inclusion to 6 months after inclusion
Title
Long-term efficacy on the impact of health on functioning: Role Emotional
Description
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.
Time Frame
From inclusion to 12 months after inclusion
Title
Efficacy on the impact of health on functioning: Role Physical
Description
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.
Time Frame
From inclusion to 6 months after inclusion
Title
Long-term efficacy on the impact of health on functioning: Role Physical
Description
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.
Time Frame
From inclusion to 12 months after inclusion
Title
Substance use
Description
Evolution of substance use over 6 months
Time Frame
From inclusion to 6 months after inclusion
Title
Long-term substance use
Description
Evolution of substance use over 12 months for the participants who are enrolled in the trial at M0 of the cohort
Time Frame
From inclusion to 12 months after inclusion
Title
Medication use
Description
Evolution of medication use over 6 months
Time Frame
From inclusion to 6 months after inclusion
Title
Long-term medication use
Description
Evolution of medication use over 12 months for the participants who are enrolled in the trial at M0 of the cohort
Time Frame
From inclusion to 12 months after inclusion
Title
Health care utilization
Description
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.
Time Frame
From inclusion to 6 months after inclusion
Title
Long-term health care utilization
Description
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
Time Frame
From inclusion to 12 months after inclusion
Title
Acceptability of EMDR in the EMDR group
Description
Proportion of those who will be offered EMDR and will actually receive EMDR
Time Frame
From inclusion to 12 months after inclusion
Title
Compliance in the EMDR group
Description
Number of sessions attended over the total planned number
Time Frame
From inclusion to 12 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wissam EL-HAGE, MD-PhD
Organizational Affiliation
University Hospital of TOURS
Official's Role
Study Director
Facility Information:
Facility Name
Centre Investigation Clinique 1415
City
Tours
State/Province
Centre Val De Loire
ZIP/Postal Code
37044
Country
France
Facility Name
Bretonneau Regional Universitary Hospital
City
Tours
ZIP/Postal Code
37044 cedex 9
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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