COVID-19BADS-PTSDNCT04473118
Assessment of Mental Health in Healthcare Workers Exposed to COVID-19 Patients
An observational study of COVID-19, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The recent COVID-19 outbreak has put the health care workers on the frontline to interact and provide support to the patients. Based on previous disease outbreak-associated studies, it is evident that these individuals are at a high-risk of developing psychological distress such as burnout, anxiety, depression, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Survey
- How many people
- 25,000 participants
- Where
- 1 siteQatar
- Study dates
- 11 Jul 2020to Jun 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: We aim to recruit around 25 thousand participants to respond to our online-based survey via email. Participants will include all healthcare staff dealing with COVID-19 patients (group 1), vs. those who are not dealing with COVID-19 patients (group 2), from hospitals and health centers inside and outside Qatar. Our questionnaires will be used to assess their mental health by measuring burnout, anxiety, depression and stress levels and post-trauma stress disorder in both groups. Participants' socio-demographic data such as age, gender, profession, marital state, native country, years of experience, weekly working hours will also be collected.
Who may be able to join
- All healthcare staff working during the COVID-19 outbreak
- Received an email with our electronic survey
- Accepted electronically to participate in our study
- Completed and submitted our electronic questionnaires successfully
- For follow-up: Accepted to receive a follow-up survey
Who cannot join
- Non-healthcare workers
- Did not accept electronically to participate in our study
- Did not complete not submitted our electronic questionnaires successfully
- For follow-up: Did not accept to receive a follow-up survey
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha
Ali Ait Hssain, 44392488, a_aithssain@hotmail.com
Ali Ait Hssain
About this study
Official title: Burnout, Anxiety, Depression, Stress (BADS) and Post-Trauma Stress Disorder (PTSD) in Healthcare Workers Exposed to COVID-19 Patients
The recent COVID-19 outbreak has put the health care workers on the frontline to interact and provide support to the patients. Based on previous disease outbreak-associated studies, it is evident that these individuals are at a high-risk of developing psychological distress such as burnout, anxiety, depression, and stress (BADS). Thus, the current study aims to evaluate the mental health outcomes of healthcare workers dealing with COVID-19 patients within Qatar and internationally, during and after the COVID-19 crisis. The participants will be divided into two groups: those working with COVID-19 patients and those not working with COVID-19 patients. The magnitude of symptoms of BADS will be assessed using electronic versions of the standardized questionnaires: Maslach Burnout Inventory (MBI-HSS), Hospital Anxiety and Depression Scale (HADS), Depression, Anxiety and Stress Scale (DASS-21), and Conditions for Work Effectiveness (CWEQ). A follow-up survey will be sent to both groups after the COVID-19 crisis to assess their vulnerability to develop post-trauma stress disorder (PTSD) using a PDS-5 survey.
Read the detailed description
Coronaviruses belong to a large family of viruses, responsible for causing mild respiratory infections such as the common cold or severe syndromes such as the Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS). A novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the most recent disease outbreak called COVID-19 that originated in Wuhan, China in December 2019. The outbreak rapidly spread to other parts of China and the world, including Qatar. As of 4th March 2020, the total number of confirmed cases in Qatar is 1325 and worldwide is 1,169,262. On 11 March 2020, the World Health Organization had declared COVID-19 as a global pandemic.
The health care workers are on the frontline providing routine and essential services to the COVID-19 patients, including diagnosis, treatment, and care. Consequently, these individuals are at a high risk of developing and experiencing psychological distress. Considering the continuously increasing suspected and confirmed COVID-19 cases, lack of specific treatment, inadequate personal protective equipment and the need for meticulous nursing care, the health care workers are overburdened mentally and are prone to mental illnesses. Not to mention, the risk of themselves getting infected due to direct exposure to patients and subsequent self-isolation they must undertake to prevent the spread to their own families, contribute to their mental burden. Undoubtedly, health care workers are working in a stressful environment that makes them susceptible to burnout syndrome, anxiety, depression, and stress (BADS). Burnout syndrome itself can cause emotional instability, feeling of failure, difficulty in making commitments, and an urge to resign (Maslach et al. 2001).
Several studies reported the psychological impact of the 2003 SARS outbreak among health care workers. The hospital staff experienced the fear of contagion and of spreading the infection to their own family, friends, and co-workers (Maunder et al. 2003, Nickell et al. 2004). Stigmatization and uncertainty were prominent among these individuals (Maunder et al. 2003, Bai et al. 2004). A recent study by Lai et al. (2019) assessing the mental health outcomes of health care workers exposed to COVID-19 patients in Wuhan, China showed that these individuals reported symptoms of anxiety, depression, distress, and insomnia. Notably, these symptoms were adversely severe in nurses and frontline health care workers in comparison to other health care workers. These studies highlight the psychosocial morbidity of disease outbreaks and stress on the need for assessing the psychosocial impact of COVID-19 on health care workers. Furthermore, conducting longitudinal studies are also essential to determine the long-term psychological impact of such outbreaks on health care workers and to identify factors that increase their vulnerability. Such studies will also allow us to assess and develop coping strategies and effective psychosocial support programs to prepare the health care workers for challenges produced by future outbreaks of such nature.
The current study aims to evaluate the mental health outcomes of healthcare workers who are on the frontline of dealing with COVID-19 patients compared to non-COVID-19 patients. We aim to assess the magnitude of symptoms of burnout, depression, anxiety, stress (BADS) and the vulnerability to post-traumatic stress disorder (PTSD) by using established survey-based tools during and after the COVID-19 crisis and performing statistical analysis of the data obtained. The participants include healthcare staff working with COVID-19 patients and those not working with COVID-19 patients as controls, inside and outside Qatar. The study is also expected to be extended internally to assess the psychological impact globally. This study is highly relevant and significant considering previous reports of psychological morbidity of disease outbreaks. It will allow the development of special interventions to provide psychosocial support to the health care workers that would need to be implemented immediately.
- Conditions
- COVID-19
- Being tested
- Survey
- Keywords
- Mental health, Burnout, Anxiety, Depression, Stress, Post-trauma stress disorder, Healthcare workers
- Medical subject headings
- COVID-19, Psychological Well-Being, Burnout, Psychological, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
An online-based questionnaire sent to participants via email
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers | All healthcare workers exposed directly or not to suspected or infected COVID-19 patients such as nurse; paramedic; senior physician; resident/ trainee physician; respiratory therapist; perfusionist; physiotherapist; dietitian; technician lab; technician imaging; pharmacist; occupational therapist; speech therapist Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
To reflect the effect of COVID-19 on the burnout, anxiety, depression and stress levels of healthcare professionals during the COVID-19 crisis
Measured: 6 months
To reflect the effect of COVID-19 on the post-trauma stress disorder levels of healthcare professionals following the COVID-19 crisis
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start11 Jul 2020
- Primary completionSep 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ali Ait Hssain, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473118
- Sponsor's protocol ID
- MRC-05-017
- Acronym
- BADS-PTSD
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burnout, Anxiety, Depression, Stress (BADS) and Post-Trauma Stress Disorder (PTSD) in Healthcare Workers Exposed to COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04473118
- Acronym / sponsor ID
- BADS-PTSD / MRC-05-017
- Conditions
- COVID-19
- Keywords
- Mental health, Burnout, Anxiety, Depression, Stress, Post-trauma stress disorder, Healthcare workers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2020 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Jul 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.
The recent COVID-19 outbreak has put the health care workers on the frontline to interact and provide support to the patients. Based on previous disease outbreak-associated studies, it is evident that these individuals are at a high-risk of developing psychological distress such as burnout, anxiety, depression, and stress (BADS). Thus, the current study aims to evaluate the mental health outcomes of healthcare workers dealing with COVID-19 patients within Qatar and internationally, during and after the COVID-19 crisis. The participants will be divided into two groups: those working with COVID-19 patients and those not working with COVID-19 patients. The magnitude of symptoms of BADS will be assessed using electronic versions of the standardized questionnaires: Maslach Burnout Inventory (MBI-HSS), Hospital Anxiety and Depression Scale (HADS), Depression, Anxiety and Stress Scale (DASS-21), and Conditions for Work Effectiveness (CWEQ). A follow-up survey will be sent to both groups after the COVID-19 crisis to assess their vulnerability to develop post-trauma stress disorder (PTSD) using a PDS-5 survey.
Detailed description
Coronaviruses belong to a large family of viruses, responsible for causing mild respiratory infections such as the common cold or severe syndromes such as the Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS). A novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the most recent disease outbreak called COVID-19 that originated in Wuhan, China in December 2019. The outbreak rapidly spread to other parts of China and the world, including Qatar. As of 4th March 2020, the total number of confirmed cases in Qatar is 1325 and worldwide is 1,169,262. On 11 March 2020, the World Health Organization had declared COVID-19 as a global pandemic.
The health care workers are on the frontline providing routine and essential services to the COVID-19 patients, including diagnosis, treatment, and care. Consequently, these individuals are at a high risk of developing and experiencing psychological distress. Considering the continuously increasing suspected and confirmed COVID-19 cases, lack of specific treatment, inadequate personal protective equipment and the need for meticulous nursing care, the health care workers are overburdened mentally and are prone to mental illnesses. Not to mention, the risk of themselves getting infected due to direct exposure to patients and subsequent self-isolation they must undertake to prevent the spread to their own families, contribute to their mental burden. Undoubtedly, health care workers are working in a stressful environment that makes them susceptible to burnout syndrome, anxiety, depression, and stress (BADS). Burnout syndrome itself can cause emotional instability, feeling of failure, difficulty in making commitments, and an urge to resign (Maslach et al. 2001).
Several studies reported the psychological impact of the 2003 SARS outbreak among health care workers. The hospital staff experienced the fear of contagion and of spreading the infection to their own family, friends, and co-workers (Maunder et al. 2003, Nickell et al. 2004). Stigmatization and uncertainty were prominent among these individuals (Maunder et al. 2003, Bai et al. 2004). A recent study by Lai et al. (2019) assessing the mental health outcomes of health care workers exposed to COVID-19 patients in Wuhan, China showed that these individuals reported symptoms of anxiety, depression, distress, and insomnia. Notably, these symptoms were adversely severe in nurses and frontline health care workers in comparison to other health care workers. These studies highlight the psychosocial morbidity of disease outbreaks and stress on the need for assessing the psychosocial impact of COVID-19 on health care workers. Furthermore, conducting longitudinal studies are also essential to determine the long-term psychological impact of such outbreaks on health care workers and to identify factors that increase their vulnerability. Such studies will also allow us to assess and develop coping strategies and effective psychosocial support programs to prepare the health care workers for challenges produced by future outbreaks of such nature.
The current study aims to evaluate the mental health outcomes of healthcare workers who are on the frontline of dealing with COVID-19 patients compared to non-COVID-19 patients. We aim to assess the magnitude of symptoms of burnout, depression, anxiety, stress (BADS) and the vulnerability to post-traumatic stress disorder (PTSD) by using established survey-based tools during and after the COVID-19 crisis and performing statistical analysis of the data obtained. The participants include healthcare staff working with COVID-19 patients and those not working with COVID-19 patients as controls, inside and outside Qatar. The study is also expected to be extended internally to assess the psychological impact globally. This study is highly relevant and significant considering previous reports of psychological morbidity of disease outbreaks. It will allow the development of special interventions to provide psychosocial support to the health care workers that would need to be implemented immediately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers | – | Other: SurveyAll healthcare workers exposed directly or not to suspected or infected COVID-19 patients such as nurse; paramedic; senior physician; resident/ trainee physician; respiratory therapist; perfusionist; physiotherapist; dietitian; technician lab; technician imaging; pharmacist; occupational therapist; speech therapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We aim to recruit around 25 thousand participants to respond to our online-based survey via email. Participants will include all healthcare staff dealing with COVID-19 patients (group 1), vs. those who are not dealing with COVID-19 patients (group 2), from hospitals and health centers inside and outside Qatar. Our questionnaires will be used to assess their mental health by measuring burnout, anxiety, depression and stress levels and post-trauma stress disorder in both groups. Participants' socio-demographic data such as age, gender, profession, marital state, native country, years of experience, weekly working hours will also be collected.
Key inclusion criteria (5 listed)
- All healthcare staff working during the COVID-19 outbreak
- Received an email with our electronic survey
- Accepted electronically to participate in our study
- Completed and submitted our electronic questionnaires successfully
- For follow-up: Accepted to receive a follow-up survey
Key exclusion criteria (4 listed)
- Non-healthcare workers
- Did not accept electronically to participate in our study
- Did not complete not submitted our electronic questionnaires successfully
- For follow-up: Did not accept to receive a follow-up survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyAn online-based questionnaire sent to participants via email | Other | Healthcare workers |
Primary outcome
To reflect the effect of COVID-19 on the burnout, anxiety, depression and stress levels of healthcare professionals during the COVID-19 crisis
Time frame: 6 months
To reflect the effect of COVID-19 on the post-trauma stress disorder levels of healthcare professionals following the COVID-19 crisis
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 COVID-19, run by Hamad Medical Corporation at 1 site in Qatar.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Jul 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 Qatar. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ali Ait Hssain (00974-77172526, a_aithssain@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To reflect the effect of COVID-19 on the burnout, anxiety, depression and stress levels of healthcare professionals during the COVID-19 crisis (time frame: 6 months). The study lists 2 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 16 Jul 2020.