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CompletedNCT04382196COVID-ImpactUpdated Dec 14, 2022

Impact of COVID-19 on Mental Health of Health Care Workers

An observational study in Mental Health and Quality of Life, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
524
Sex
All
01

Study summary

The impact of the current Covid-19 pandemic on healthcare workers is enormous. This longitudinal study investigates the prevalence of mental health problems and the quality of life of healthcare workers during and after the Covid-19 pandemic. Underlying risk factors are also examined. Health care workers of the different Covid-19 cohort and transit wards, as well as the intensive care unit and (psychiatric) emergency services of the Ghent university hospital will be included, as well as the health care workers of 6 non-Covid-19 wards.

Read the detailed description

The impact of the current Covid-19 pandemic on healthcare workers is enormous. Previous studies during the SARS outbreak demonstrated a significant burden and increase of mental health problems in health care workers.This longitudinal study aims to investigate the prevalence of mental health problems and the quality of life of health care workers during and after the Covid-19 pandemic. Health care workers of the different Covid-19 cohort and transit wards, as well as the intensive care unit and (psychiatric) emergency services of the Ghent university hospital will be included, as well as the health care workers of 6 non-Covid-19 wards. Participants will receive a monthly online survey during the government issued restrictions. After cessation of the restrictions participants will receive three-monthly surveys for a one-year-period.

Sociodemographic data, data regarding employment and previous mental health problems will be collected at the first survey. The Covid-19 status of the health care workers will be inquired at every survey. The Depression, Anxiety and Stress Scale (DASS-21), the Dutch translation of the Covid-19 Peritraumatic Distress Index (CPDI), the WHO Quality of Life-BREF (WHOQOL-BREF), and the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and three items measuring social support will be administered at every survey.

02

Conditions studied

  • Mental Health
  • Quality of Life

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Keywords

  • Health care workers
  • Covid-19
  • Mental health
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 524 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All personnel of the above specified services of the university hospital involved in direct or indirect care will be eligible for inclusion

Inclusion criteria

  • health care worker
  • employed at inclusion at Covid cohort/transit or (psychiatric) emergency services or intensive care unit or 6 specified wards of the Ghent University Hospital

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
524 participants (actual)
Patient registry
No

Groups and cohorts

  • Health care workers

    Health care workers at university hospital

    Other: Online survey

Interventions

  • OtherOnline survey

    An online survey will be administered

06

What researchers measure

Primary outcomes

  1. Depressive symptoms at baseline

    Depressive symptoms as measured by the 7-item depression subscale of the self-reported 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression). A higher score indicates more depressive symptoms with a minimum score of 0 and a maximum score of 21.

    Time frame: Baseline

  2. Change in depressive symptoms

    Depressive symptoms as measured by the 7-item depression subscale of the self-reported 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression). A higher score indicates more depressive symptoms with a minimum score of 0 and a maximum score of 21.

    Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days

  3. Anxiety levels at baseline

    Anxiety as measured by the 7-item anxiety subscale of the self-reported DASS-21 (DASS-21-Anxiety). A higher score indicates higher anxiety levels with a minimum score of 0 and a maximum score of 21.

    Time frame: Baseline

  4. Change in anxiety levels

    Anxiety as measured by the 7-item anxiety subscale of the self-reported DASS-21 (DASS-21-Anxiety). A higher score indicates higher anxiety levels with a minimum score of 0 and a maximum score of 21.

    Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days

  5. Stress levels at baseline

    Stress as measured by the 7-item stress subscale of the self-reported DASS-21 (DASS-21-Stress). A higher score indicates higher stress levels with a minimum score of 0 and a maximum score of 21.

    Time frame: Baseline

  6. Change in stress levels

    Stress as measured by the 7-item stress subscale of the self-reported DASS-21 (DASS-21-Stress). A higher score indicates higher stress levels with a minimum score of 0 and a maximum score of 21.

    Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days

  7. Quality of life at baseline

    Quality of life will be measured by the WHO Quality of Life Bref Questionnaire (WHOQOL-BREF). This self-report questionnaire has a minimum score of 0 and a maximum score of 100 with a higher score indicating higher quality of life. It includes different domains such as physical health, psychological health, social relationships and environment as well as two specific questions regarding an individual's overall perception of quality of life and physical health.

    Time frame: Baseline

  8. Change in Quality of life

    Quality of life will be measured by the WHO Quality of Life Bref Questionnaire (WHOQOL-BREF). This self-report questionnaire has a minimum score of 0 and a maximum score of 100 with a higher score indicating higher quality of life. It includes different domains such as physical health, psychological health, social relationships and environment as well as two specific questions regarding an individual's overall perception of quality of life and physical health.

    Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days

  9. Covid-19 related psychological distress

    Specific distress regarding Covd-19 will be measured by the Dutch translation of the COVID-19 Peritraumatic Distress Index (CPDI). This self-reported questionnaire inquires about the frequency of anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behaviour, physical symptoms and loss of social functioning in the past week. The score ranges from 0 to 100, with higher scores indicating more distress.

    Time frame: baseline

  10. Change in Covid-19 related psychological distress

    Specific distress regarding Covd-19 will be measured by the Dutch translation of the COVID-19 Peritraumatic Distress Index (CPDI). This self-reported questionnaire inquires about the frequency of anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behaviour, physical symptoms and loss of social functioning in the past week. The score ranges from 0 to 100, with higher scores indicating more distress.

    Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days

  11. Post traumatic stress symptoms

    The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) is a 5-item screen that was designed for use in primary care settings. The measure begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0. However, if a respondent indicates that they have experienced a traumatic event over the course of their life, the respondent is instructed to respond to five additional yes/no questions about how that trauma exposure has affected them over the past month. The minimum score is 0 and the maximum score is 5 with higher scores indicating more PTSD-related symptoms.

    Time frame: Baseline

  12. Change in post traumatic stress symptoms

    The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) is a 5-item screen that was designed for use in primary care settings. The measure begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0. However, if a respondent indicates that they have experienced a traumatic event over the course of their life, the respondent is instructed to respond to five additional yes/no questions about how that trauma exposure has affected them over the past month. The minimum score is 0 and the maximum score is 5 with higher scores indicating more PTSD-related symptoms.

    Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days

Secondary outcomes

  1. Perceived social support at baseline

    Social support (from colleagues and employer) as perceived by participants will be measured by three items as measured on a 5-point Likert scale. For each item the minimum score is 1 and the maximum score is 5.

    Time frame: Baseline

  2. Change in perceived social support

    Social support (from colleagues and employer) as perceived by participants will be measured by three items as measured on a 5-point Likert scale. For each item the minimum score is 1 and the maximum score is 5.

    Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days

07

Study locations

1 site
  • Ghent University Hospital
    Ghent, 9000, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04382196
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
May 11, 2020
Start date
Apr 17, 2020
Primary completion
Jun 6, 2022
Completion
Jun 6, 2022
Last update
Dec 14, 2022

Study contacts

Gilbert Lemmens
study director · University Hospital, Ghent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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