Clinical trial NCT04570202: Health cAre woRkers exposeD to COVID-19
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-09-30
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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) .

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

Primary outcomes:
measure: Efficacy on symptoms of Post-Traumatic Stress Disorder
timeFrame: From inclusion to 6 months after inclusion
measure: Efficacy on symptoms of Burnout
timeFrame: From inclusion to 6 months after inclusion
measure: Efficacy on symptoms of Depression
timeFrame: From inclusion to 6 months after inclusion
Secondary outcomes:
measure: Short-term efficacy on symptoms of PTSD
timeFrame: From inclusion to 3 months after inclusion
measure: Short-term efficacy on symptoms of Burnout
timeFrame: From inclusion to 3 months after inclusion
measure: Short-term efficacy on symptoms of Depression
timeFrame: From inclusion to 3 months after inclusion
measure: Long-term efficacy on symptoms of PTSD
timeFrame: From inclusion to 12 months after inclusion
measure: Long-term efficacy on symptoms of Burnout
timeFrame: From inclusion to 12 months after inclusion
measure: Long-term efficacy on symptoms of Depression
timeFrame: From inclusion to 12 months after inclusion
measure: Efficacy on symptoms of Anxiety
timeFrame: From inclusion to 6 months after inclusion
measure: Long-term efficacy on symptoms of Anxiety
timeFrame: From inclusion to 12 months after inclusion
measure: Efficacy on suicide attempts
timeFrame: From inclusion to 6 months after inclusion
Other outcomes:
measure: Efficacy on suicidal ideation
timeFrame: From inclusion to 6 months after inclusion
measure: Long-term efficacy on suicidal ideation
timeFrame: From inclusion to 12 months after inclusion
measure: Efficacy on the impact of health on functioning: Role Emotional
timeFrame: From inclusion to 6 months after inclusion
measure: Long-term efficacy on the impact of health on functioning: Role Emotional
timeFrame: From inclusion to 12 months after inclusion
measure: Efficacy on the impact of health on functioning: Role Physical
timeFrame: From inclusion to 6 months after inclusion
measure: Long-term efficacy on the impact of health on functioning: Role Physical
timeFrame: From inclusion to 12 months after inclusion
measure: Substance use
timeFrame: From inclusion to 6 months after inclusion
measure: Long-term substance use
timeFrame: From inclusion to 12 months after inclusion
measure: Medication use
timeFrame: From inclusion to 6 months after inclusion
measure: Long-term medication use
timeFrame: From inclusion to 12 months after inclusion
measure: Health care utilization
timeFrame: From inclusion to 6 months after inclusion
measure: Long-term health care utilization
timeFrame: From inclusion to 12 months after inclusion
measure: Acceptability of EMDR in the EMDR group
timeFrame: From inclusion to 12 months after inclusion
measure: Compliance in the EMDR group
timeFrame: From inclusion to 12 months after inclusion
Locations:
city: Tours
country: France
facility: Centre Investigation Clinique 1415
state: Centre Val De Loire
city: Tours
country: France
facility: Bretonneau Regional Universitary Hospital
Study officials:
affiliation: University Hospital of TOURS
name: Wissam EL-HAGE, MD-PhD
role: STUDY_DIRECTOR
References: