Health cAre woRkers exposeD to COVID-19

NCT04570202 | Completed

• 3 other identifiers: DR200160-HARD-COVID-192020-A01642-371-20-046 ID 48680
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

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).

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• Short-term efficacy on symptoms of PTSD

  From inclusion to 3 months after inclusion

• Short-term efficacy on symptoms of Burnout

  From inclusion to 3 months after inclusion

• Short-term efficacy on symptoms of Depression

  From inclusion to 3 months after inclusion

• Long-term efficacy on symptoms of PTSD

  From inclusion to 12 months after inclusion

• Long-term efficacy on symptoms of Burnout

  From inclusion to 12 months after inclusion

Other Outcomes (14)

• Efficacy on suicidal ideation

  From inclusion to 6 months after inclusion

• Long-term efficacy on suicidal ideation

  From inclusion to 12 months after inclusion

• Efficacy on the impact of health on functioning: Role Emotional

  From inclusion to 6 months after inclusion

Study Arms (2)

Usual Care

NO INTERVENTION

Subject from this group are screened positive for psychological distress but they will only receive standard of care.

Eye Movement Desensitization & Reprocessing Group

EXPERIMENTAL

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.

Behavioral: EMDR

Interventions

EMDR BEHAVIORAL

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

Eye Movement Desensitization & Reprocessing Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.
• 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.

You may not qualify if:

• none
• none

Sponsors & Collaborators

• University Hospital, Tours: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Centre Investigation Clinique 1415

Tours, Centre-Val de Loire, 37044, France

Location

Bretonneau Regional Universitary Hospital

Tours, 37044 cedex 9, France

Location

Related Publications (1)

• Caille A, Allemang-Trivalle A, Blanchin M, Rebion A, Sauvaget A, Gohier B, Birmes P, Bui E, Fakra E, Krebs MO, Lemogne C, Prieto N, Jalenques I, Vidailhet P, Aouizerate B, Hingray C, El-Hage W. EMDR for symptoms of depression, stress and burnout in health care workers exposed to COVID-19 (HARD): A study protocol for a trial within a cohort study. Eur J Psychotraumatol. 2023;14(1):2179569. doi: 10.1080/20008066.2023.2179569.

  PMID: 37052108 DERIVED

MeSH Terms

Conditions

Depression; Burnout, Professional; Stress Disorders, Post-Traumatic; COVID-19; Burnout, Psychological

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Occupational Stress; Occupational Diseases; Stress, Psychological; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Wissam EL-HAGE, MD-PhD

  University Hospital of TOURS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: September 30, 2020
• Study Start: November 20, 2020
• Primary Completion: July 17, 2022
• Study Completion: January 31, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)