Covid-19HEROESNCT04352634
The Covid-19 HEalth caRe wOrkErS (HEROES) Study
An observational study of Covid-19 and Mental Health Disorder, run by University of Chile at 22 sites in 21 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19, Mental Health Disorder, Stress Disorder
- What is being tested?
- Exposure to the SARS-CoV-2 and its consequences
- How many people
- 2,000 participants
- Where
- 22 sitesin 21 countries
- Study dates
- 26 Apr 2020to 31 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include workers who interact with people with confirmed or suspected COVID-19 at different health services (primary care centers, emergency units, specialized care units, inpatient care units, critically ill patient units, among others). Potential participants will include any type of worker in these centers, including clinical and administrative staff, as well as supportive staff (e.g., food services)
Who may be able to join
- Legal age
- Currently working on a health service that provides care to COVID-19 patients
- Give informed consent
Who cannot join
- Inability to use electronic devices (required to complete the survey)
Trial locations and contacts
22 sites in 21 countries.
22 sites in 21 countries
Italy2 sites, 2 recruiting
- Recruiting
University of Cagliari
Cagliari, CA, 09124
Maria Francesca Moro, MD, +390706093498, mm4640@cumc.columbia.edu
Mauro Giovanni Carta, MD, +390706093498, maurogcarta@gmail.com
- Not yet recruiting
University of Cagliari
Cagliari
Francesca Moro, MD, mm4640@cumc.columbia.edu
Mauro Carta, MD
United States1 site
- Active, not recruiting
Columbia University
New York, New York, 10032
Argentina1 site, 1 recruiting
- Recruiting
Universidad del Chubut
Rawson, Chubut Province, 9103
Marcela Inés Freytes Frey, PhD, 5492804263454, mifreytesfrey@udc.edu.ar
Rodrigo Ezequiel Jaldo, BsC, 5493513908707, rejaldo@udc.edu.ar
Armenia1 site, 1 recruiting
- Recruiting
National Institute of Health Named After Academician S. Avdalbekyan
Yerevan, 0051
Anna Isahakyan, MD, +37499990074, annaisahakian@gmail.com
Arin A Balalian, MD, MPH
Australia1 site, 1 recruiting
- Not yet recruiting
University of Sydney
Sydney, New South Wales, 2031
Clare A McCormack, PhD, 3477129331, cam2348@cumc.columbia.edu
Sonja Memedovic, PhD, s.memedovic@unsw.edu.au
Bolivia1 site, 1 recruiting
- Not yet recruiting
Salud Global
Sucre, Chuquisaca Department
María Teresa Solís Soto, MD, PhD, 59173295148, maritesolissoto@gmail.com
Armando Basagoitia Echalar, MD, MsC, 59170324803, armando.basagoitia@gmail.com
Chile1 site, 1 recruiting
- Not yet recruiting
University of Chile
Santiago
Rubén Alvarado, PhD, +56 2 2978 6967, ralvarado@med.uchile.cl
Sara Schilling, MPH
Costa Rica1 site, 1 recruiting
- Not yet recruiting
Universidad Nacional de Costa Rica
Heredia, 863000
Iliana Araya Ramírez, MD, PhD, 50683897058, iliana.araya.ramirez@una.cr
María Chaves Villalobos, MsC, 50688865120, maria.chaves.villalobos@una.cr
Czechia1 site, 1 recruiting
- Recruiting
Society for Emergecy and Disaster Medicine CzMA JEP
Kladno, Bohemia, 27201
Jana Seblova, MD, PhD, 00420724568877, seblo@volny.cz
Jana Seblova, MD, PhD
Germany1 site, 1 recruiting
- Recruiting
Hochschule Emden/Leer
Emden, Lower Saxony, 26723
Jutta Lindert, MD, PhD, 00491774158919, Jutta.Lindert@hs-emden-leer.de
Marta Natan
Guatemala1 site, 1 recruiting
- Recruiting
Centro de Investigaciones de las Ciencias de la Salud -CICS- Facultad de Ciencias Médicas Universidad de San Carlos de Guatemala -USAC-
Guatemala City, 01011
Dorian E Ramírez Flores, MD, MsC, 50224187459, dramirez2198@medicina.usac.edu.gt
Víctor Puac-Polanco, MD, MsC, 50224187459, vdp2105@cumc.columbia.edu
Lebanon1 site, 1 recruiting
- Not yet recruiting
The Institute for Development Research Advocacy and Applied Care (IDRAAC)
Beirut, 11002110
Elie Karam, MD, 9611583583, egkaram@idraac.org
Georges Karam, MD, 9611583583, georges.karam@idraac.org
Mexico1 site, 1 recruiting
- Recruiting
Logotipo del comercio Instituto Jalisciense De Salud Mental (SALME)
Guadalajara, Jalisco, 45170
Jaime Carmona Huerta, MD, PhD, 3322562339, drjcarmonah@gmail.com
Allen Akcel Rodríguez, BsC, 3313585332, allen-ar@hotmail.com
Netherlands1 site, 1 recruiting
- Not yet recruiting
Maastricht University
Maastricht, Limburg, 6229
Els van der Ven, PhD, +17185367406, elsjevanderven@gmail.com
Els van der Ven, PhD
Nigeria1 site, 1 recruiting
- Not yet recruiting
University of Ibadan
Ibadan, Oyo State, 200220
Oye Gureje, MD, PhD, +2348033464284, oye_gureje@yahoo.com
Olatunde Ayinde, MD, MsC, +2348032107441, oayinde@brandeis.edu
Puerto Rico1 site, 1 recruiting
- Recruiting
Ponce Health Sciences University
Ponce, 00716
Eliut Rivera-Segarra, PhD, 7874596312, elrivera@psm.edu
Eliut Rivera-Segarra, PhD
Saudi Arabia1 site, 1 recruiting
- Not yet recruiting
King Abdullah International medical research center
Riyadh, Central, 11522
Lubna Alnasser, MsC, 00966504468135, la2580@cumc.columbia.edu
Sulainam Alghnam, PhD, 00966539468887, alghnams@ngha.med.sa
Spain1 site, 1 recruiting
- Recruiting
Hospital La Paz Institute for Health Research (IdiPAZ)
Madrid, 28046
Roberto Mediavilla, PhD, +347270000, roberto.mediavilla@idipaz.es
Eduardo Fernández-Jiménez, PhD, +347270000, efjimenez@salud.madrid.org
Tunisia1 site, 1 recruiting
- Recruiting
Razi Hospital La Manouba
Tunis, La Manouba
Uta Ouali, MD, +21623266078, uta.ouali@gmail.com
Fethi Nacef, MD, +21698302065, fethi.nacef@yahoo.fr
Turkey (Türkiye)1 site
- Active, not recruiting
Koc University
Istanbul, Sariyer, 34450
Venezuela1 site, 1 recruiting
- Recruiting
PNFA Salud Colectiva Instituto de Altos Estudios Dr Arnoldo Gabaldon
Maracay, Aragua, 2103
Ana Maria Rodrigues Rodrigues, MsC, +5804264325417, anamrodrigues1985@gmail.com
Juan Quintana, MsC, +5804166467999, juanadrian1@yahoo.es
About this study
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
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.
Read the detailed 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).
- Conditions
- Covid-19, Mental Health Disorder, Stress Disorder, Anxiety, Depression, SARS-CoV-2
- Being tested
- Exposure to the SARS-CoV-2 and its consequences
- Keywords
- Covid-19, healthcare professionals, mental health, pandemic
- Medical subject headings
- COVID-19, Mental Disorders, Stress Disorders, Traumatic, Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to the SARS-CoV-2 and its consequencesOther
This is an observational design. Participants are exposed to the SARS-CoV-2, the Covid-19 pandemic, and/or its consequences
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers | Workers who interact with people with confirmed or suspected COVID-19 at different health services (primary care centers, emergency units, specialized care units, inpatient care units, critically ill patient units, among others). Potential participants will include any type of worker in these centers, including clinical and administrative staff, as well as supportive staff (e.g., food services) Receives: Other: Exposure to the SARS-CoV-2 and its consequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (31)
Experiences, fears and concerns about the Covid-19
Ad hoc survey on experiences, fears, and concerns about Covid-19
Measured: Baseline
Experiences, fears and concerns about the Covid-19
Ad hoc survey on experiences, fears, and concerns about Covid-19
Measured: 3 months
Experiences, fears and concerns about the Covid-19
Ad hoc survey on experiences, fears, and concerns about Covid-19
Measured: 6 months
Experiences, fears and concerns about the Covid-19
Ad hoc survey on experiences, fears, and concerns about Covid-19
Measured: 12 months
Training and resource prioritization
Ad hoc survey on Covid-19 training and resource prioritization
Measured: Baseline
Training and resource prioritization
Ad hoc survey on Covid-19 training and resource prioritization
Measured: 3 months
Training and resource prioritization
Ad hoc survey on Covid-19 training and resource prioritization
Measured: 6 months
Training and resource prioritization
Ad hoc survey on Covid-19 training and resource prioritization
Measured: 12 months
Suicide ideation (presence)
Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Measured: Baseline
Suicide ideation (presence)
Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Measured: 3 months
Suicide ideation (presence)
Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Measured: 6 months
Suicide ideation (presence)
Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Measured: 12 months
Suicide ideation (frequency)
5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Measured: Baseline
Suicide ideation (frequency)
5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Measured: 3 months
Suicide ideation (frequency)
5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Measured: 6 months
Suicide ideation (frequency)
5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Measured: 12 months
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
Measured: Baseline
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
Measured: 3 months
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
Measured: 6 months
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
Measured: 12 months
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
Measured: Baseline
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
Measured: 3 months
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
Measured: 6 months
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
Measured: 12 months
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.
Measured: Baseline
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 12 months
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
Measured: Baseline
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
Measured: 3 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start26 Apr 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Rubén Alvarado, University of Chile
- Investigators
- Rubén Alvarado, PhD, Principal investigator, University of Chile [Universidad de Chile]Ezra Susser, MD DrPH, Principal investigator, Columbia UniversityFranco Mascayano, MPH, Principal investigator, Columbia Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352634
- Sponsor's protocol ID
- HEROES Covid-19
- Acronym
- HEROES
- Status last verified
- Mar 2021
- First submitted
- 8 Apr 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32112714Nacoti 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)
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.
PubMed 32764825Lai 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.
PubMed 32202646Asaoka H, Watanabe K, Miyamoto Y, Restrepo-Henao A, van der Ven E, Moro MF, Alnasser LA, Ayinde O, Balalian AA, Basagoitia A, Durand-Arias S, Eskin M, Fernandez-Jimenez E, Ines FFM, Gimenez L, Hoek HW, Jaldo RE, Lindert J, Maldonado H, Martinez-Ales G, Mediavilla R, McCormack C, Narvaez J, Ouali U, Barrera-Perez A, Calgua-Guerra E, Ramirez J, Rodriguez AM, Seblova D, da Silva ATC, Valeri L, Gureje O, Ballester D, Carta MG, Isahakyan A, Jamoussi A, Seblova J, Solis-Soto MT, Alvarado R, Susser E, Mascayano F, Nishi D; HEROES group. Association of depressive symptoms with incidence and mortality rates of COVID-19 over 2 years among healthcare workers in 20 countries: multi-country serial cross-sectional study. BMC Med. 2024 Sep 12;22(1):386. doi: 10.1186/s12916-024-03585-8.
PubMed 39267052
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04352634
- Acronym / sponsor ID
- HEROES / HEROES Covid-19
- Conditions
- Covid-19, Mental Health Disorder, Stress Disorder, Anxiety, Depression, SARS-CoV-2
- Keywords
- Covid-19, healthcare professionals, mental health, pandemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 26 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Apr 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.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers | – | Other: Exposure to the SARS-CoV-2 and its consequencesWorkers who interact with people with confirmed or suspected COVID-19 at different health services (primary care centers, emergency units, specialized care units, inpatient care units, critically ill patient units, among others). Potential participants will include any type of worker in these centers, including clinical and administrative staff, as well as supportive staff (e.g., food services) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include workers who interact with people with confirmed or suspected COVID-19 at different health services (primary care centers, emergency units, specialized care units, inpatient care units, critically ill patient units, among others). Potential participants will include any type of worker in these centers, including clinical and administrative staff, as well as supportive staff (e.g., food services)
Key inclusion criteria (3 listed)
- Legal age
- Currently working on a health service that provides care to COVID-19 patients
- Give informed consent
Key exclusion criteria (1 listed)
- Inability to use electronic devices (required to complete the 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 |
|---|---|---|
| Exposure to the SARS-CoV-2 and its consequencesThis is an observational design. Participants are exposed to the SARS-CoV-2, the Covid-19 pandemic, and/or its consequences | Other | Healthcare workers |
Primary outcome
Anxiety and depressive symptoms
Time frame: 12 months
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
31 secondary outcomes
Experiences, fears and concerns about the Covid-19
Time frame: Baseline
Experiences, fears and concerns about the Covid-19
Time frame: 3 months
Experiences, fears and concerns about the Covid-19
Time frame: 6 months
Experiences, fears and concerns about the Covid-19
Time frame: 12 months
Training and resource prioritization
Time frame: Baseline
Training and resource prioritization
Time frame: 3 months
Training and resource prioritization
Time frame: 6 months
Training and resource prioritization
Time frame: 12 months
Suicide ideation (presence)
Time frame: Baseline
Suicide ideation (presence)
Time frame: 3 months
Suicide ideation (presence)
Time frame: 6 months
Suicide ideation (presence)
Time frame: 12 months
Suicide ideation (frequency)
Time frame: Baseline
Suicide ideation (frequency)
Time frame: 3 months
Suicide ideation (frequency)
Time frame: 6 months
Suicide ideation (frequency)
Time frame: 12 months
Acute stress symptoms
Time frame: Baseline
Acute stress symptoms
Time frame: 3 months
Acute stress symptoms
Time frame: 6 months
Acute stress symptoms
Time frame: 12 months
Psycho/social support and network
Time frame: Baseline
Psycho/social support and network
Time frame: 3 months
Psycho/social support and network
Time frame: 6 months
Psycho/social support and network
Time frame: 12 months
Resilience
Time frame: Baseline
Resilience
Time frame: 3 months
Resilience
Time frame: 6 months
Resilience
Time frame: 12 months
Anxiety and depressive symptoms
Time frame: Baseline
Anxiety and depressive symptoms
Time frame: 3 months
Anxiety and depressive symptoms
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 32112714Brooks 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.
- BackgroundNacoti 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)
- Background: PubMed 32764825Huang 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.
- Background: PubMed 32202646Lai 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.
- Derived from this study: PubMed 39267052Asaoka H, Watanabe K, Miyamoto Y, Restrepo-Henao A, van der Ven E, Moro MF, Alnasser LA, Ayinde O, Balalian AA, Basagoitia A, Durand-Arias S, Eskin M, Fernandez-Jimenez E, Ines FFM, Gimenez L, Hoek HW, Jaldo RE, Lindert J, Maldonado H, Martinez-Ales G, Mediavilla R, McCormack C, Narvaez J, Ouali U, Barrera-Perez A, Calgua-Guerra E, Ramirez J, Rodriguez AM, Seblova D, da Silva ATC, Valeri L, Gureje O, Ballester D, Carta MG, Isahakyan A, Jamoussi A, Seblova J, Solis-Soto MT, Alvarado R, Susser E, Mascayano F, Nishi D; HEROES group. Association of depressive symptoms with incidence and mortality rates of COVID-19 over 2 years among healthcare workers in 20 countries: multi-country serial cross-sectional study. BMC Med. 2024 Sep 12;22(1):386. doi: 10.1186/s12916-024-03585-8.
- 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.
Rubén Alvarado, PhD principal investigator
University of Chile [Universidad de Chile]
Ezra Susser, MD DrPH principal investigator
Columbia University
Franco Mascayano, MPH principal investigator
Columbia Universty
22 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Mental Health Disorder, run by University of Chile at 22 sites in 21 countries.
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 3 inclusion and 1 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy, United States, Argentina, Armenia, Australia and 16 more countries. 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 Rubén Alvarado, PhD (+56 2 2978 6967, ralvarado@med.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depressive symptoms (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04352634, which also lists 5 linked publications.
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 1 Apr 2021.