- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04397848
Mental Health Outcomes in Healthcare Workers During COVID-19
Hearing and Supporting the Healthcare Workers: Mental Health Outcomes in Healthcare Workers During COVID-19
Study Overview
Status
Detailed Description
Previous work conducted by our group during the 2003 SARS outbreak demonstrated symptoms of post-traumatic stress disorder (PTSD) and depression in healthcare workers (HCWs) working in high-risk areas. Similar reports are emerging with regards to HCWs during COVID-19 which may affect staff mental health outcomes which may have effects on staff absenteeism and retention.
The study is a cross-sectional, multi-centered, hospital-based online survey conducted at several Toronto hospitals. Participants will be recruited to participate in the voluntary study via an internal e-mail that will contain a short description of the study and a link to the online survey. The survey will take approximately 25 minutes to complete. The study group will include HCW s from high-risk units (Emergency, ICU, and COVID-19 units) with a comparison group of HCWs who are not directly involved in the assessment or management of patients with COVID-19.
This study will evaluate the psychological impact of the COVID-19 pandemic on HCW's and identify risk factors that may place HCWs at greater risk for negative psychological outcomes. The survey will gather information such as s basic, non-identifying demographic information, hospital and unit of work, quarantine and isolation, work with patients diagnosed with COVID-19, loss of loved ones to COVID-19, understanding of the reasons for PPE/ infection control directives, perceptions of risk to self and family, sources of support. As well, Toronto is in the unique situation of having been at the centre of the 2003 Canadian SARS outbreak and presently experiencing the impact of the COVID-19. The investigators propose that COVID-19 might have a differential impact on the psychological wellbeing of current HCWs depending on whether they practiced during SARS. Our survey will explore the differences of the psychological impact of the COVID-19 pandemic on healthcare workers who lived through the SARS outbreak and those who did not. The following validated scales are embedded in the survey to evaluate the psychological impact of the COVID pandemic: Impact of Event Scale-Revised (IES-R), Generalized Anxiety Disorder -7 (GAD-7) , and Patient Health Questionnaire (PHQ-9). Open-ended questions will also provide respondents the opportunity to relate aspects of working during the COVID-19 pandemic that are most difficult and to provide additional comments on their unique experiences.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
HCW currently working at Toronto based hospitals: University Health Network (UHN), Sunnybrook Health Sciences and William Osler Health System.
Exclusion Criteria: Not a healthcare worker
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of Event Scale - Revised (IES-R)
Time Frame: Two weeks
|
Scale to evaluate Post-traumatic Stress Disorder symptoms
|
Two weeks
|
|
General Anxiety Disorder (GAD-7)
Time Frame: Two weeks
|
Scale to evaluate anxiety symptoms
|
Two weeks
|
|
Patient Health Questionnaire (PHQ-9)
Time Frame: Two weeks
|
Scale to evaluate depressive symptoms
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Data
Time Frame: Two weeks
|
Qualitative data will be coded and analyzed to show emerging themes.
|
Two weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rima Styra, MD, MEd, University Health Network, Toronto
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3189
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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