Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)

COVID-19 is an infectious disease caused by the last coronavirus discovered, called SARS-CoV-2. Symptoms encountered in COVID-19 are: cough, breathing difficulties (dyspnea, chest pain, etc.), pyrexia, anosmia (loss of smell) and/or dysgeusia (loss of taste), but also ENT symptoms (rhinitis type, odynophagia), headaches, asthenia, muscle pain, confusion and diarrhea. Infection with SARS-CoV-2 can also be asymptomatic. COVID-19 can be passed from person to person by respiratory droplets expelled when a person speaks, coughs or sneezes. The currently estimated incubation period ranges from 1 to 14 days, and most often this is around 5 days.

According to a literature review, there is strong evidence that COVID-19 has an impact on mental health (anxiety being the most common symptom) whether in the general population, healthcare workers or vulnerable populations. The objective of this project is to assess mental health and sleep disorders within two populations: elderly patients and nursing staff.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 1150

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Subjects 65 years of age or older, having been hospitalized for COVID-19 within the CHU Brugmann Hospital
• People aged 18 or over, member of the nursing staff of the CHU Brugmann Hospital, having worked during COVID-19.

Description

Inclusion Criteria:

• Subjects 65 years of age or older, having been hospitalized for COVID-19 within the CHU Brugmann Hospital
• People aged 18 or over, member of the nursing staff of the CHU Brugmann Hospital, having worked during COVID-19.

Exclusion Criteria:

• Incoherent patients
• Severe presbycusis
• Oral expression impairment
• Insurmountable language barrier

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elderly patients; Elderly patients (over 65 years old) hospitalized for COVID-19 within the CHU Brugmann Hospital	Other: Questionnaire; Data collection by means of various questionnaires
Health Care professionals; Health Care professionals working within the CHU Brugmann Hospital	Other: Questionnaire; Data collection by means of various questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact Event Scale-Revised (IES-R)	The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events.Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.	15 minutes
Generalised Anxiety Disorder-7 (GAD-7)	Self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD).The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.	15 minutes
Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment.	15 minutes
Insomnia severity index (ISI)	The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	Age, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).	1 year
Hospitalization duration	Hospitalization duration	1 year
ICU stay	Hospitalization within the intensive care unit (yes/no) with or without intubation	1 year
Medical history	History of chronic diseases	1 year
Alcohol consumption	Alcohol consumption : none - stable - increased - diminished	1 year
Tobacco consumption	Tobacco consumption : none - stable - increased - diminished	1 year

Collaborators and Investigators

• Sponsor: Murielle Surquin
• Investigators: Principal Investigator: Sophie Levy, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; COVID-19; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: CHU-COVIDIMPACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No