Mental HealthCOVID-ImpactNCT04382196
Impact of COVID-19 on Mental Health of Health Care Workers
An observational study of Mental Health and Quality of Life, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Quality of Life
- What is being tested?
- Online survey
- How many people
- 524 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Apr 2020to 6 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All personnel of the above specified services of the university hospital involved in direct or indirect care will be eligible for inclusion
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of the COVID-19 Pandemic on Mental Health and Quality of Life of Healthcare Workers in a University Hospital
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.
- Conditions
- Mental Health, Quality of Life
- Being tested
- Online survey
- Keywords
- Health care workers, Covid-19, Mental health
- Medical subject headings
- Psychological Well-Being, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online surveyOther
An online survey will be administered
| Study group | Role | What they receive |
|---|---|---|
| Health care workers | Health care workers at university hospital Receives: Other: Online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
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.
Measured: Baseline
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.
Measured: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
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.
Measured: Baseline
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.
Measured: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
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.
Measured: Baseline
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.
Measured: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
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.
Measured: baseline
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.
Measured: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
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.
Measured: Baseline
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.
Measured: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
Secondary outcomes (2)
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.
Measured: Baseline
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.
Measured: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start17 Apr 2020
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert Lemmens, Study director, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382196
- Sponsor's protocol ID
- BC-07564
- Acronym
- COVID-Impact
- Status last verified
- Dec 2022
- First submitted
- 8 May 2020
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the COVID-19 Pandemic on Mental Health and Quality of Life of Healthcare Workers in a University Hospital
- ClinicalTrials.gov ID
- NCT04382196
- Acronym / sponsor ID
- COVID-Impact / BC-07564
- Conditions
- Mental Health, Quality of Life
- Keywords
- Health care workers, Covid-19, Mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health care workers | – | Other: Online surveyHealth care workers at university hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All personnel of the above specified services of the university hospital involved in direct or indirect care will be eligible for inclusion
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online surveyAn online survey will be administered | Other | Health care workers |
Primary outcome
Depressive symptoms at baseline
Time frame: 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.
Change in depressive 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
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.
Anxiety levels at baseline
Time frame: 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.
Change in anxiety levels
Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
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.
Stress levels at baseline
Time frame: 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.
Change in stress levels
Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
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.
Quality of life at baseline
Time frame: 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.
Change in Quality of life
Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
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.
Covid-19 related psychological distress
Time frame: baseline
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.
Change in Covid-19 related psychological 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
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.
Post traumatic stress symptoms
Time frame: Baseline
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.
Change in post traumatic stress 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
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.
2 secondary outcomes
Perceived social support at baseline
Time frame: Baseline
Change in perceived social support
Time frame: Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert Lemmens study director
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Quality of Life, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms at baseline (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.