Health cAre woRkers exposeD to COVID-19

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 20, 2021

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) .

Interventions

  • Behavioral: EMDR
    • The EMDR therapy is organized in eight different phases, requiring attending multiple sessions, usually 12 separate sessions.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Tours
  • Collaborator
    • Institut National de la Santé Et de la Recherche Médicale, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wissam EL-HAGE, MD-PhD, Study Director, University Hospital of TOURS
  • Overall Contact(s)
    • Wissam EL-HAGE, MD-PhD, +332 47 47 80 43, wissam.elhage@univ-tours.fr

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