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)
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:

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) .

Completed
Depression
Burnout, Professional
Post Traumatic Stress Disorder

Behavioral: EMDR

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

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Centre Investigation Clinique 1415
Tours, Centre Val De Loire, France

Bretonneau Regional Universitary Hospital
Tours, France

Wissam EL-HAGE, MD-PhD, Study Director
University Hospital of TOURS

Institut National de la Santé Et de la Recherche Médicale, France
NCT Number
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
MeSH Terms
COVID-19
Burnout, Professional
Depression
Depressive Disorder
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Burnout, Psychological