- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04382196
Impact of COVID-19 on Mental Health of Health Care Workers (COVID-Impact)
The Impact of the COVID-19 Pandemic on Mental Health and Quality of Life of Healthcare Workers in a University Hospital
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium, 9000
- Ghent University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- none
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Health care workers
Health care workers at university hospital
|
An online survey will be administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
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
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.
|
Baseline
|
|
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.
|
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
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.
|
Baseline
|
|
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.
|
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
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.
|
Baseline
|
|
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.
|
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
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.
|
baseline
|
|
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.
|
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
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.
|
Baseline
|
|
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.
|
Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived social support at baseline
Time Frame: 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.
|
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
|
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.
|
Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gilbert Lemmens, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-07564
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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