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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04382196
Other study ID # BC-07564
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 17, 2020
Est. completion date June 6, 2022

Study information

Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 524
Est. completion date June 6, 2022
Est. primary completion date June 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Online survey
An online survey will be administered

Locations

Country Name City State
Belgium Ghent University Hospital Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
Primary 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. Baseline
Primary 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. Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
Primary 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. Baseline
Primary 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. Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
Primary 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. Baseline
Primary 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. Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
Primary 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. baseline
Primary 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. Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
Primary 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. Baseline
Primary 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. Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
Secondary 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. Baseline
Secondary 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. Baseline, baseline + 30 days, baseline + 90 days, baseline + 180 days, baseline + 270 days, baseline + 360 days, baseline + 540 days, baseline + 900 days
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