NCT04382196

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
524

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

2.1 years

First QC Date

May 8, 2020

Last Update Submit

December 13, 2022

Conditions

Keywords

Health care workersCovid-19Mental health

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Perceived social support at baseline

    Baseline

  • Change in perceived social support

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

Study Arms (1)

Health care workers

Health care workers at university hospital

Other: Online survey

Interventions

An online survey will be administered

Health care workers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • health care worker

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Psychological Well-BeingCOVID-19

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gilbert Lemmens

    University Hospital, Ghent

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 11, 2020

Study Start

April 17, 2020

Primary Completion

June 6, 2022

Study Completion

June 6, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Locations