Health cAre woRkers exposeD to COVID-19

Depression Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570202
• Other study ID #: DR200160-HARD-COVID-19
• Secondary ID: 2020-A01642-371-
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: January 31, 2023
• Est. primary completion date: July 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological
• COVID-19
• Depression
• Depressive Disorder
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
France	Bretonneau Regional Universitary Hospital	Tours
France	Centre Investigation Clinique 1415	Tours	Centre Val De Loire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy on suicidal ideation	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.	From inclusion to 6 months after inclusion
Other	Long-term efficacy on suicidal ideation	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.	From inclusion to 12 months after inclusion
Other	Efficacy on the impact of health on functioning: Role Emotional	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.	From inclusion to 6 months after inclusion
Other	Long-term efficacy on the impact of health on functioning: Role Emotional	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.	From inclusion to 12 months after inclusion
Other	Efficacy on the impact of health on functioning: Role Physical	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.	From inclusion to 6 months after inclusion
Other	Long-term efficacy on the impact of health on functioning: Role Physical	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.	From inclusion to 12 months after inclusion
Other	Substance use	Evolution of substance use over 6 months	From inclusion to 6 months after inclusion
Other	Long-term substance use	Evolution of substance use over 12 months for the participants who are enrolled in the trial at M0 of the cohort	From inclusion to 12 months after inclusion
Other	Medication use	Evolution of medication use over 6 months	From inclusion to 6 months after inclusion
Other	Long-term medication use	Evolution of medication use over 12 months for the participants who are enrolled in the trial at M0 of the cohort	From inclusion to 12 months after inclusion
Other	Health care utilization	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.	From inclusion to 6 months after inclusion
Other	Long-term health care utilization	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	From inclusion to 12 months after inclusion
Other	Acceptability of EMDR in the EMDR group	Proportion of those who will be offered EMDR and will actually receive EMDR	From inclusion to 12 months after inclusion
Other	Compliance in the EMDR group	Number of sessions attended over the total planned number	From inclusion to 12 months after inclusion
Primary	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.	From inclusion to 6 months after inclusion
Primary	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.	From inclusion to 6 months after inclusion
Primary	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.	From inclusion to 6 months after inclusion
Secondary	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.	From inclusion to 3 months after inclusion
Secondary	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.	From inclusion to 3 months after inclusion
Secondary	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.	From inclusion to 3 months after inclusion
Secondary	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.	From inclusion to 12 months after inclusion
Secondary	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.	From inclusion to 12 months after inclusion
Secondary	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.	From inclusion to 12 months after inclusion
Secondary	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.	From inclusion to 6 months after inclusion
Secondary	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.	From inclusion to 12 months after inclusion
Secondary	Efficacy on suicide attempts	Number of suicide attempts over a 6-month period from baseline	From inclusion to 6 months after inclusion