The Covid-19 HEalth caRe wOrkErS (HEROES) Study

Depression Clinical Trial

— HEROES  

Official title:

The Impact of the Covid-19 Pandemic on the Mental Health of Workers in Health Services: The Covid-19 HEalth caRe wOrkErS (HEROES) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04352634
• Other study ID #: HEROES Covid-19
• Status: Recruiting
• Start date: April 26, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: University of Chile
• Contact: Rubén Alvarado, PhD
• Phone: +56 2 2978 6967
• Email: ralvarado[@]med.uchile.cl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population.

Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress).

The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.

Description:

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Based on the literature to date, Covid-19 is significantly larger than previous pandemics in terms of the number of affected people worldwide, its spread across countries, its impact on healthcare systems and the severity of measures that have been taken by governments. Immediate consequences are palpable in the health care system. Many healthcare workers are overwhelmed by the increased workload; the lack of supplies and materials to provide appropriate treatment; the lack of clinical guidelines on prioritization and triage; and the increased feelings of isolation and loneliness. Previous research indicates that these negative effects can last over time and lead to the development of serious mental health problems such as post-traumatic stress disorder.

Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). Also, it is necessary to take into account the nature and the extent of the health response (e.g., deployment, increased workload) in order to advance our understanding of these complex phenomenon and to inform policy and develop the kind of supports that this population deems useful.

The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.

Participants will complete an online questionnaire, which will be completely self-administered. It will take approximately 12 minutes and includes sociodemographic data, questions on work activity, training, fears and concerns related to Covid-19, as well as the GHQ-12 and a series of questions on other mental health issues (e.g., suicide, acute stress), resilience and psycho/social factors (e.g., formal and informal support).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Legal age

• Currently working on a health service that provides care to COVID-19 patients

• Give informed consent

Exclusion Criteria:

• Inability to use electronic devices (required to complete the survey)

Related Conditions & MeSH terms

• Anxiety
• Covid-19
• Depression
• Disease
• Mental Disorders
• Mental Health Disorder
• SARS-CoV-2
• Stress Disorder

Intervention

Other:
• Exposure to the SARS-CoV-2 and its consequences
This is an observational design. Participants are exposed to the SARS-CoV-2, the Covid-19 pandemic, and/or its consequences

Locations

Country	Name	City	State
Argentina	Universidad del Chubut	Rawson	Chubut
Armenia	National Institute of Health Named After Academician S. Avdalbekyan	Yerevan
Australia	University of Sydney	Sidney	New South Wales
Bolivia	Salud Global	Sucre	Chuquisaca
Chile	University of Chile	Santiago
Costa Rica	Universidad Nacional de Costa Rica	Heredia
Czechia	Society for Emergecy and Disaster Medicine CzMA JEP	Kladno	Bohemia
Germany	Hochschule Emden/Leer	Emden	Niedersachsen
Guatemala	Centro de Investigaciones de las Ciencias de la Salud -CICS- Facultad de Ciencias Médicas Universidad de San Carlos de Guatemala -USAC-	Guatemala City
Italy	University of Cagliari	Cagliari	CA
Italy	University of Cagliari	Cagliari
Lebanon	The Institute for Development Research Advocacy and Applied Care (IDRAAC)	Beirut
Mexico	Logotipo del comercio Instituto Jalisciense De Salud Mental (SALME)	Guadalajara	Jalisco
Netherlands	Maastricht University	Maastricht	Limburg
Nigeria	University of Ibadan	Ibadan	Oyo State
Puerto Rico	Ponce Health Sciences University	Ponce
Saudi Arabia	King Abdullah International medical research center	Riyadh	Central
Spain	Hospital La Paz Institute for Health Research (IdiPAZ)	Madrid
Tunisia	Razi Hospital La Manouba	Tunis	La Manouba
Turkey	Koc University	Istanbul	Sariyer
United States	Columbia University	New York	New York
Venezuela	PNFA Salud Colectiva Instituto de Altos Estudios Dr Arnoldo Gabaldon	Maracay	Aragua

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Columbia University

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Armenia,  Australia,  Bolivia,  Chile,  Costa Rica,  Czechia,  Germany,  Guatemala,  Italy,  Lebanon,  Mexico,  Netherlands,  Nigeria,  Puerto Rico,  Saudi Arabia,  Spain,  Tunisia,  Turkey, 

References & Publications (4)

Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26. Review. — View Citation

Huang L, Lei W, Xu F, Liu H, Yu L. Emotional responses and coping strategies in nurses and nursing students during Covid-19 outbreak: A comparative study. PLoS One. 2020 Aug 7;15(8):e0237303. doi: 10.1371/journal.pone.0237303. eCollection 2020. — View Citation

Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976. — View Citation

Nacoti M, et al. At the Epicenter of the Covid-19 Pandemic and Humanitarian Crises in Italy: Changing Perspectives on Preparation and Mitigation. NEJM Catalyst, 2020;1(2)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and depressive symptoms	The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries	12 months
Secondary	Experiences, fears and concerns about the Covid-19	Ad hoc survey on experiences, fears, and concerns about Covid-19	Baseline
Secondary	Experiences, fears and concerns about the Covid-19	Ad hoc survey on experiences, fears, and concerns about Covid-19	3 months
Secondary	Experiences, fears and concerns about the Covid-19	Ad hoc survey on experiences, fears, and concerns about Covid-19	6 months
Secondary	Experiences, fears and concerns about the Covid-19	Ad hoc survey on experiences, fears, and concerns about Covid-19	12 months
Secondary	Training and resource prioritization	Ad hoc survey on Covid-19 training and resource prioritization	Baseline
Secondary	Training and resource prioritization	Ad hoc survey on Covid-19 training and resource prioritization	3 months
Secondary	Training and resource prioritization	Ad hoc survey on Covid-19 training and resource prioritization	6 months
Secondary	Training and resource prioritization	Ad hoc survey on Covid-19 training and resource prioritization	12 months
Secondary	Suicide ideation (presence)	Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)	Baseline
Secondary	Suicide ideation (presence)	Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)	3 months
Secondary	Suicide ideation (presence)	Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)	6 months
Secondary	Suicide ideation (presence)	Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)	12 months
Secondary	Suicide ideation (frequency)	5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.	Baseline
Secondary	Suicide ideation (frequency)	5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.	3 months
Secondary	Suicide ideation (frequency)	5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.	6 months
Secondary	Suicide ideation (frequency)	5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.	12 months
Secondary	Acute stress symptoms	Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms	Baseline
Secondary	Acute stress symptoms	Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms	3 months
Secondary	Acute stress symptoms	Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms	6 months
Secondary	Acute stress symptoms	Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms	12 months
Secondary	Psycho/social support and network	Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support	Baseline
Secondary	Psycho/social support and network	Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support	3 months
Secondary	Psycho/social support and network	Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support	6 months
Secondary	Psycho/social support and network	Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support	12 months
Secondary	Resilience	The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.	Baseline
Secondary	Resilience	The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.	3 months
Secondary	Resilience	The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.	6 months
Secondary	Resilience	The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.	12 months
Secondary	Anxiety and depressive symptoms	The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries	Baseline
Secondary	Anxiety and depressive symptoms	The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries	3 months
Secondary	Anxiety and depressive symptoms	The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries	6 months