Mental Health Wellness 1NCT04397848
Mental Health Outcomes in Healthcare Workers During COVID-19
An observational study of Mental Health Wellness 1 and PTSD, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
An online survey will be sent to healthcare workers (HCWs) in acute care hospitals to explore a variety of risk factors for negative psychological outcomes and levels of anxiety, depression and post-traumatic stress symptoms using validated scales. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, PTSD, Anxiety
- How many people
- 3,852 participants
- Where
- 1 siteCanada
- Study dates
- 14 May 2020to 3 Jul 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group will include all HCWs working within the hospital system. This will include HCWs from high-risk units such as Emergency, ICU, and COVID-19 units as well as HCWs who are not directly involved in the assessment or management of patients with COVID-19.
Who may be able to join
- HCW currently working at Toronto based hospitals: University Health Network (UHN), Sunnybrook Health Sciences and William Osler Health System.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hearing and Supporting the Healthcare Workers: Mental Health Outcomes in Healthcare Workers During COVID-19
An online survey will be sent to healthcare workers (HCWs) in acute care hospitals to explore a variety of risk factors for negative psychological outcomes and levels of anxiety, depression and post-traumatic stress symptoms using validated scales. It is important to understand the sources of negative psychological impact on HCWs during this COVID-19 pandemic before hospitals and organizations can address and develop support programs to mitigate the stresses experienced by healthcare workers. Addressing and supporting the needs of our HCWs will be paramount in this COVID-19 pandemic and future outbreaks.
Read the 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.
- Conditions
- Mental Health Wellness 1, PTSD, Anxiety, Stress, Depression, COVID-19
- Keywords
- Healthcare Workers, COVID-19, Mental Health Outcomes
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Event Scale - Revised (IES-R)
Scale to evaluate Post-traumatic Stress Disorder symptoms
Measured: Two weeks
General Anxiety Disorder (GAD-7)
Scale to evaluate anxiety symptoms
Measured: Two weeks
Patient Health Questionnaire (PHQ-9)
Scale to evaluate depressive symptoms
Measured: Two weeks
Secondary outcomes (1)
Qualitative Data
Qualitative data will be coded and analyzed to show emerging themes.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start14 May 2020
- Primary completion3 Jul 2020
- Study completion3 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 3,852 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- William Osler Health System, University of Toronto, Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Rima Styra, University Health Network, Toronto
- Investigators
- Rima Styra, MD, MEd, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397848
- Sponsor's protocol ID
- 3189
- Status last verified
- Nov 2020
- First submitted
- 19 May 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing and Supporting the Healthcare Workers: Mental Health Outcomes in Healthcare Workers During COVID-19
- ClinicalTrials.gov ID
- NCT04397848
- Acronym / sponsor ID
- 3189
- Conditions
- Mental Health Wellness 1, PTSD, Anxiety, Stress, Depression, COVID-19
- Keywords
- Healthcare Workers, COVID-19, Mental Health Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,852 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- William Osler Health System, University of Toronto, Sunnybrook Health Sciences Centre
- Study start
- 14 May 2020 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 21 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.
An online survey will be sent to healthcare workers (HCWs) in acute care hospitals to explore a variety of risk factors for negative psychological outcomes and levels of anxiety, depression and post-traumatic stress symptoms using validated scales. It is important to understand the sources of negative psychological impact on HCWs during this COVID-19 pandemic before hospitals and organizations can address and develop support programs to mitigate the stresses experienced by healthcare workers. Addressing and supporting the needs of our HCWs will be paramount in this COVID-19 pandemic and future outbreaks.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will include all HCWs working within the hospital system. This will include HCWs from high-risk units such as Emergency, ICU, and COVID-19 units as well as HCWs who are not directly involved in the assessment or management of patients with COVID-19.
Key inclusion criteria (1 listed)
- HCW currently working at Toronto based hospitals: University Health Network (UHN), Sunnybrook Health Sciences and William Osler Health System.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of Event Scale - Revised (IES-R)
Time frame: Two weeks
Scale to evaluate Post-traumatic Stress Disorder symptoms
General Anxiety Disorder (GAD-7)
Time frame: Two weeks
Scale to evaluate anxiety symptoms
Patient Health Questionnaire (PHQ-9)
Time frame: Two weeks
Scale to evaluate depressive symptoms
1 secondary outcome
Qualitative Data
Time frame: Two weeks
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 3 Nov 2020.
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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.
Rima Styra, MD, MEd principal investigator
University Health Network, Toronto
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 Wellness 1 and PTSD, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 0 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 3 Nov 2020. 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 Canada. 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?
Impact of Event Scale - Revised (IES-R) (time frame: Two weeks). The study lists 3 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 3 Nov 2020.