Assessment of Mental Health in Healthcare Workers Exposed to COVID-19 Patients

COVID-19 Clinical Trial

— BADS-PTSD  

Official title:

Burnout, Anxiety, Depression, Stress (BADS) and Post-Trauma Stress Disorder (PTSD) in Healthcare Workers Exposed to COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04473118
• Other study ID #: MRC-05-017
• Status: Recruiting
• Start date: July 11, 2020
• Est. completion date: June 2021

Study information

• Verified date: July 2020
• Source: Hamad Medical Corporation
• Contact: Dr. Ali Ait Hssain
• Phone: 00974-77172526
• Email: a_aithssain[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: June 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Survey
An online-based questionnaire sent to participants via email

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To reflect the effect of COVID-19 on the burnout, anxiety, depression and stress levels of healthcare professionals during the COVID-19 crisis		6 months
Primary	To reflect the effect of COVID-19 on the post-trauma stress disorder levels of healthcare professionals following the COVID-19 crisis		9 months