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

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ClinicalTrials.gov Identifier: NCT04570202
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Tours

Tracking Information
First Submitted Date  ICMJE September 28, 2020
First Posted Date  ICMJE September 30, 2020
Last Update Posted Date November 24, 2020
Actual Study Start Date  ICMJE November 20, 2020
Estimated Primary Completion Date August 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2020)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Efficacy on suicide attempts [ Time Frame: From inclusion to 6 months after inclusion ]
    Number of suicide attempts over a 6-month period from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 29, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Substance use [ Time Frame: From inclusion to 6 months after inclusion ]
    Evolution of substance use over 6 months
  • 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
  • Medication use [ Time Frame: From inclusion to 6 months after inclusion ]
    Evolution of medication use over 6 months
  • 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
  • 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.
  • 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
  • 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
  • Compliance in the EMDR group [ Time Frame: From inclusion to 12 months after inclusion ]
    Number of sessions attended over the total planned number
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Health cAre woRkers exposeD to COVID-19
Official Title  ICMJE 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)
Brief Summary

Hospital health workers 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

Hospital health workers 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 personnel 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Burnout, Professional
  • Post Traumatic Stress Disorder
Intervention  ICMJE Behavioral: EMDR
The EMDR therapy is organized in eight different phases, requiring attending multiple sessions, usually 12 separate sessions.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: EMDR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2020)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 20, 2022
Estimated Primary Completion Date August 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wissam EL-HAGE, MD-PhD +332 47 47 80 43 wissam.elhage@univ-tours.fr
Contact: Wiebe de JONG, MSc +33 2 47 47 46 80 w.dejong@chu-tours.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04570202
Other Study ID Numbers  ICMJE DR200160-HARD-COVID-19
2020-A01642-37 ( Registry Identifier: ID-RCB )
1-20-046 ID 48680 ( Other Identifier: CPP SOOM-1 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Tours
Study Sponsor  ICMJE University Hospital, Tours
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Study Director: Wissam EL-HAGE, MD-PhD University Hospital of TOURS
PRS Account University Hospital, Tours
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP