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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04497246
Enrollment
1150
Registered
2020-08-04
Start date
2020-05-29
Completion date
2021-08-20
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

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.

Interventions

OTHERQuestionnaire

Data collection by means of various questionnaires

Sponsors

Murielle Surquin
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Impact Event Scale-Revised (IES-R)15 minutesThe 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.
Generalised Anxiety Disorder-7 (GAD-7)15 minutesSelf-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.
Patient Health Questionnaire-9 (PHQ-9)15 minutesThe 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.
Insomnia severity index (ISI)15 minutesThe 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).

Secondary

MeasureTime frameDescription
Alcohol consumption1 yearAlcohol consumption : none - stable - increased - diminished
Demographic data1 yearAge, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).
Tobacco consumption1 yearTobacco consumption : none - stable - increased - diminished
Hospitalization duration1 yearHospitalization duration
ICU stay1 yearHospitalization within the intensive care unit (yes/no) with or without intubation
Medical history1 yearHistory of chronic diseases

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026