Acute Stress DisorderNCT04486404
Needs, Perceptions and Acute Stress of Healtcare Workers Caring for COVID-19 Patients in South America
An observational study of Acute Stress Disorder, run by Universidad Miguel Hernandez de Elche at 5 sites in 5 countries.
Trial summary
The pressure on care and the demand for critical decision-making generated by the current SARS-CoV-2 (COVID-19) pandemic, together with the situation of extreme social alarm and the adverse conditions in which care work must be promoted at this time, draw an extreme scenario in which action is urgently needed to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Stress Disorder
- What is being tested?
- Online survey
- How many people
- 1,800 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Apr 2020to 30 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: Healthcare personnel in the front line of exposure to suspicious and confirmed cases of COVID-19 and healthcare support personnel (administrative assistants, cleaning or security personnel) of these services and units, such as Emergency and Primary Health Care Services, Internal Medicine, Critical Care and Resuscitation, Intermediate Care and any other area designated for the care of such cases.
Who may be able to join
- Healthcare professionals, other professionals working in the front-line of COVID-19.
Who cannot join
- -
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Argentina1 site
Institute for Clinical Effectiveness and Health Policy
Buenos Aires
About this study
Official title: Personal Protective Equipmente Needs, Perceptions and Acute Stress Among Healthcare Workers Caring for COVID-19 Patients in South America
The pressure on care and the demand for critical decision-making generated by the current SARS-CoV-2 (COVID-19) pandemic, together with the situation of extreme social alarm and the adverse conditions in which care work must be promoted at this time, draw an extreme scenario in which action is urgently needed to alleviate emotional overload, acute stress reactions and other affective pathologies or psychosomatic reactions that may eventually lead to post-traumatic stress situations. This eventuality is being observed massively among professionals from different groups and levels of responsibility.
In the case of healthcare personnel, it should be added that the care of non-COVID19 patients (of all pathologies and conditions) is clearly compromised and it is up to the professionals as a whole to make critical decisions and exercise a professional practice that is radically different from what has usually been done, which may require the application of undesirable triage criteria that are difficult for everyone to assume.
Read more
Healthcare professionals and other essential personnel for healthcare and social-healthcare work (including personnel from external companies) are being subjected to emotional tensions and extraordinary, high-intensity work demands. Without professionals who feel supported and with moral strength, care will be even more compromised.
The current scenario makes us think of many critical situations that are occurring as a result of the overload experienced. It is essential to act in order to counteract the devastating effect of this health crisis on health professionals and those who support them in their care work.
Read the detailed description
Coronavirus 2019 disease - of recent appearance - has become a global public health problem due to its rapid spread, since 11 March declared by WHO as a pandemic. It represents a real challenge for health systems, which at first lack information to organize the response to this situation, effective treatments to combat this lethal infection and with health personnel lacking the necessary security in their daily work to minimize the risk of contagion. The COVID-19 pandemic has caused, up to July 21, more than 609,000 deaths worldwide, 28,422 in Spain. The number of professionals suffering from COVID-19 is high. In Spain it accounts for more than 20% of the total number of people infected.
In this way, health professionals have been taking on a notable role without hardly any intention of doing so. Situations of constant uncertainty and emotional distress have posed a risk to patients and to the quality of care, making health professionals the second most affected by SARS-CoV-2 (COVID-19), which also requires special biosecurity and protection measures.
In a global survey, 52% of the 2711 health workers included reported that at least 1 standard PPE piece was out of stock. For example, in the United States, the Food and Drug Administration and the Centers for Disease Control and Prevention have taken several steps to optimize the use of PPE due to its scarcity. Although professionals in Germany consider that they have been well prepared for the pandemic, there are substantial differences in the availability of PPE depending on the health professional and the setting (outpatient or acute care hospitals). In Spain, 54% of primary health care workers reported that they were not adequately trained to use PPE. No similar studies we found in the local context of South American countries.
Although the incidence of the pandemic has expanded differently in different geographical areas of each country, most hospitals and health centres around the world have had to reorganise themselves to prioritise the care of COVID-19 patients, breaking with their usual work dynamics. To this cause of work stress must be added the uncertainty in which decisions have had to be made and the lack of resources both to treat patients adequately and to protect against possible contagion. Reactions of compassionate fatigue, post-traumatic stress, and moral damage have been observed among health professionals, which has depended on the expansion of the pandemic, available means, and individual differences in stress response.
These types of responses and reactions to this crisis are natural and affect all staff and all professional levels, including care support staff (IT, supplies, cleaning, etc.). The opposite would be difficult to explain. However, the key question is not the number of professionals who have been emotionally affected as a result of their care work, a circumstance that is aggravated in this crisis but is inherent to the work they do, but rather how many are unable to recover, how their resilience is evolving or to what extent they are able to cope with a possible new outbreak.
Most studies have analysed the emotional responses in a short period of time (approximately one week) coinciding with a specific stage of the crisis. However, studies on community coping with catastrophic situations have described that the psychological response evolves over time resulting in: impact phase, heroic (intensification of efforts), honeymoon (optimism), disillusionment (fatigue) and restoration (recovery pre-crisis levels). Therefore, it is expected that the effects of the pandemic on the psychological and emotional well-being of health professionals will vary as the pandemic evolves.
- Conditions
- Acute Stress Disorder
- Being tested
- Online survey
- Keywords
- COVID-19, Healthcare Personnel, Mental Health, Acute stress, Hospitals, Primary care
- Medical subject headings
- Stress Disorders, Traumatic, Acute, COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online surveyOther
Online survey including questions related to PPE availability, perceptions, emotions and EASE scale (Acute Stress Scale).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Online survery to healtcare personnel and other professionals in the front-line from Col, Bra and Ec. Receives: Other: Online survey | |
| Group 2 | Online survery to healtcare personnel and other professionals in the front-line from Col, Bra, Ch and Ec. Receives: Other: Online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Acute Stress
Prevalence of acute stress using the Acute Stress Scale (EASE Scale) among healthcare personnel in the front-line caring for COVID-19 patients.
Score values range from 0 to 30. 0-9 points, good emotional adjustment; 10-14 points, emotional distress; 15-24 points, medium-high emotional overload; > 25 points, extreme acute stress.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Apr 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute Stress DisorderStudies 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
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Catolica Santiago de Guayaquil, Universidad de Santander, University of Sao Paulo, Pontificia Universidad Catolica de Chile
- Responsible party
- Principal investigator, José Joaquín Mira, Universidad Miguel Hernandez de Elche
- Investigators
- Jose J Mira, PhD, Principal investigator, Universidad Miguel Hernández de Elche.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486404
- Sponsor's protocol ID
- 08/04/2020
- Status last verified
- Sep 2022
- First submitted
- 23 Jul 2020
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Auxemery Y. Treatment of post-traumatic psychiatric disorders: A continuum of immediate, post-immediate and follow-up care mediated by specific psychotherapeutic principles. Clinical experience in French-speaking countries. Encephale. 2018 Nov;44(5):403-408. doi: 10.1016/j.encep.2018.02.003. Epub 2018 Jun 8.
PubMed 29887301Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available.
PubMed 32085839Everly GS Jr, Mitchell JT. The debriefing "controversy" and crisis intervention: a review of lexical and substantive issues. Int J Emerg Ment Health. 2000 Fall;2(4):211-25.
PubMed 11217152Kang L, Li Y, Hu S, Chen M, Yang C, Yang BX, Wang Y, Hu J, Lai J, Ma X, Chen J, Guan L, Wang G, Ma H, Liu Z. The mental health of medical workers in Wuhan, China dealing with the 2019 novel coronavirus. Lancet Psychiatry. 2020 Mar;7(3):e14. doi: 10.1016/S2215-0366(20)30047-X. Epub 2020 Feb 5. No abstract available.
PubMed 32035030Khalid I, Khalid TJ, Qabajah MR, Barnard AG, Qushmaq IA. Healthcare Workers Emotions, Perceived Stressors and Coping Strategies During a MERS-CoV Outbreak. Clin Med Res. 2016 Mar;14(1):7-14. doi: 10.3121/cmr.2016.1303. Epub 2016 Feb 4.
PubMed 26847480Li W, Yang Y, Liu ZH, Zhao YJ, Zhang Q, Zhang L, Cheung T, Xiang YT. Progression of Mental Health Services during the COVID-19 Outbreak in China. Int J Biol Sci. 2020 Mar 15;16(10):1732-1738. doi: 10.7150/ijbs.45120. eCollection 2020.
PubMed 32226291Mira JJ, Carrillo I, Guilabert M, Lorenzo S, Perez-Perez P, Silvestre C, Ferrus L; Spanish Second Victim Research Team. The Second Victim Phenomenon After a Clinical Error: The Design and Evaluation of a Website to Reduce Caregivers' Emotional Responses After a Clinical Error. J Med Internet Res. 2017 Jun 8;19(6):e203. doi: 10.2196/jmir.7840.
PubMed 28596148Mira JJ, Carrillo I, Lorenzo S, Ferrus L, Silvestre C, Perez-Perez P, Olivera G, Iglesias F, Zavala E, Maderuelo-Fernandez JA, Vitaller J, Nuno-Solinis R, Astier P; Research Group on Second and Third Victims. The aftermath of adverse events in Spanish primary care and hospital health professionals. BMC Health Serv Res. 2015 Apr 9;15:151. doi: 10.1186/s12913-015-0790-7.
PubMed 25886369Mitchell JT. Innovative, precise, and descriptive terms for group crisis support services: a United Nations initiative. Int J Emerg Ment Health. 2007 Fall;9(4):247-52.
PubMed 18459528Scott SD, Hirschinger LE, Cox KR, McCoig M, Hahn-Cover K, Epperly KM, Phillips EC, Hall LW. Caring for our own: deploying a systemwide second victim rapid response team. Jt Comm J Qual Patient Saf. 2010 May;36(5):233-40. doi: 10.1016/s1553-7250(10)36038-7.
PubMed 20480757Wu P, Fang Y, Guan Z, Fan B, Kong J, Yao Z, Liu X, Fuller CJ, Susser E, Lu J, Hoven CW. The psychological impact of the SARS epidemic on hospital employees in China: exposure, risk perception, and altruistic acceptance of risk. Can J Psychiatry. 2009 May;54(5):302-11. doi: 10.1177/070674370905400504.
PubMed 19497162Xiang YT, Yang Y, Li W, Zhang L, Zhang Q, Cheung T, Ng CH. Timely mental health care for the 2019 novel coronavirus outbreak is urgently needed. Lancet Psychiatry. 2020 Mar;7(3):228-229. doi: 10.1016/S2215-0366(20)30046-8. Epub 2020 Feb 4. No abstract available.
PubMed 32032543Martin-Delgado J, Poblete R, Serpa P, Mula A, Carrillo I, Fernandez C, Vicente Ripoll MA, Loudet C, Jorro F, Garcia Elorrio E, Guilabert M, Mira JJ. Contributing factors for acute stress in healthcare workers caring for COVID-19 patients in Argentina, Chile, Colombia, and Ecuador. Sci Rep. 2022 May 19;12(1):8496. doi: 10.1038/s41598-022-12626-2.
PubMed 35589975Martin-Delgado J, Viteri E, Mula A, Serpa P, Pacheco G, Prada D, Campos de Andrade Lourencao D, Campos Pavan Baptista P, Ramirez G, Mira JJ. Availability of personal protective equipment and diagnostic and treatment facilities for healthcare workers involved in COVID-19 care: A cross-sectional study in Brazil, Colombia, and Ecuador. PLoS One. 2020 Nov 11;15(11):e0242185. doi: 10.1371/journal.pone.0242185. eCollection 2020.
PubMed 33175877
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Protective Equipmente Needs, Perceptions and Acute Stress Among Healthcare Workers Caring for COVID-19 Patients in South America
- ClinicalTrials.gov ID
- NCT04486404
- Acronym / sponsor ID
- 08/04/2020
- Conditions
- Acute Stress Disorder
- Keywords
- COVID-19, Healthcare Personnel, Mental Health, Acute stress, Hospitals, Primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Universidad Catolica Santiago de Guayaquil, Universidad de Santander, University of Sao Paulo, Pontificia Universidad Catolica de Chile
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 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 pressure on care and the demand for critical decision-making generated by the current SARS-CoV-2 (COVID-19) pandemic, together with the situation of extreme social alarm and the adverse conditions in which care work must be promoted at this time, draw an extreme scenario in which action is urgently needed to alleviate emotional overload, acute stress reactions and other affective pathologies or psychosomatic reactions that may eventually lead to post-traumatic stress situations. This eventuality is being observed massively among professionals from different groups and levels of responsibility.
In the case of healthcare personnel, it should be added that the care of non-COVID19 patients (of all pathologies and conditions) is clearly compromised and it is up to the professionals as a whole to make critical decisions and exercise a professional practice that is radically different from what has usually been done, which may require the application of undesirable triage criteria that are difficult for everyone to assume.
Healthcare professionals and other essential personnel for healthcare and social-healthcare work (including personnel from external companies) are being subjected to emotional tensions and extraordinary, high-intensity work demands. Without professionals who feel supported and with moral strength, care will be even more compromised.
The current scenario makes us think of many critical situations that are occurring as a result of the overload experienced. It is essential to act in order to counteract the devastating effect of this health crisis on health professionals and those who support them in their care work.
Detailed description
Coronavirus 2019 disease - of recent appearance - has become a global public health problem due to its rapid spread, since 11 March declared by WHO as a pandemic. It represents a real challenge for health systems, which at first lack information to organize the response to this situation, effective treatments to combat this lethal infection and with health personnel lacking the necessary security in their daily work to minimize the risk of contagion. The COVID-19 pandemic has caused, up to July 21, more than 609,000 deaths worldwide, 28,422 in Spain. The number of professionals suffering from COVID-19 is high. In Spain it accounts for more than 20% of the total number of people infected.
In this way, health professionals have been taking on a notable role without hardly any intention of doing so. Situations of constant uncertainty and emotional distress have posed a risk to patients and to the quality of care, making health professionals the second most affected by SARS-CoV-2 (COVID-19), which also requires special biosecurity and protection measures.
In a global survey, 52% of the 2711 health workers included reported that at least 1 standard PPE piece was out of stock. For example, in the United States, the Food and Drug Administration and the Centers for Disease Control and Prevention have taken several steps to optimize the use of PPE due to its scarcity. Although professionals in Germany consider that they have been well prepared for the pandemic, there are substantial differences in the availability of PPE depending on the health professional and the setting (outpatient or acute care hospitals). In Spain, 54% of primary health care workers reported that they were not adequately trained to use PPE. No similar studies we found in the local context of South American countries.
Although the incidence of the pandemic has expanded differently in different geographical areas of each country, most hospitals and health centres around the world have had to reorganise themselves to prioritise the care of COVID-19 patients, breaking with their usual work dynamics. To this cause of work stress must be added the uncertainty in which decisions have had to be made and the lack of resources both to treat patients adequately and to protect against possible contagion. Reactions of compassionate fatigue, post-traumatic stress, and moral damage have been observed among health professionals, which has depended on the expansion of the pandemic, available means, and individual differences in stress response.
These types of responses and reactions to this crisis are natural and affect all staff and all professional levels, including care support staff (IT, supplies, cleaning, etc.). The opposite would be difficult to explain. However, the key question is not the number of professionals who have been emotionally affected as a result of their care work, a circumstance that is aggravated in this crisis but is inherent to the work they do, but rather how many are unable to recover, how their resilience is evolving or to what extent they are able to cope with a possible new outbreak.
Most studies have analysed the emotional responses in a short period of time (approximately one week) coinciding with a specific stage of the crisis. However, studies on community coping with catastrophic situations have described that the psychological response evolves over time resulting in: impact phase, heroic (intensification of efforts), honeymoon (optimism), disillusionment (fatigue) and restoration (recovery pre-crisis levels). Therefore, it is expected that the effects of the pandemic on the psychological and emotional well-being of health professionals will vary as the pandemic evolves.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Online surveyOnline survery to healtcare personnel and other professionals in the front-line from Col, Bra and Ec. |
| Group 2 | – | Other: Online surveyOnline survery to healtcare personnel and other professionals in the front-line from Col, Bra, Ch and Ec. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare personnel in the front line of exposure to suspicious and confirmed cases of COVID-19 and healthcare support personnel (administrative assistants, cleaning or security personnel) of these services and units, such as Emergency and Primary Health Care Services, Internal Medicine, Critical Care and Resuscitation, Intermediate Care and any other area designated for the care of such cases.
Key inclusion criteria (1 listed)
- Healthcare professionals, other professionals working in the front-line of COVID-19.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Online surveyOnline survey including questions related to PPE availability, perceptions, emotions and EASE scale (Acute Stress Scale). | Other | Group 1, Group 2 |
Primary outcome
Prevalence of Acute Stress
Time frame: 15 days
Prevalence of acute stress using the Acute Stress Scale (EASE Scale) among healthcare personnel in the front-line caring for COVID-19 patients. Score values range from 0 to 30. 0-9 points, good emotional adjustment; 10-14 points, emotional distress; 15-24 points, medium-high emotional overload; > 25 points, extreme acute stress.
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 19 Sep 2022.
- Background: PubMed 29887301Auxemery Y. Treatment of post-traumatic psychiatric disorders: A continuum of immediate, post-immediate and follow-up care mediated by specific psychotherapeutic principles. Clinical experience in French-speaking countries. Encephale. 2018 Nov;44(5):403-408. doi: 10.1016/j.encep.2018.02.003. Epub 2018 Jun 8.
- Background: PubMed 32085839Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 11217152Everly GS Jr, Mitchell JT. The debriefing "controversy" and crisis intervention: a review of lexical and substantive issues. Int J Emerg Ment Health. 2000 Fall;2(4):211-25.
- Background: PubMed 32035030Kang L, Li Y, Hu S, Chen M, Yang C, Yang BX, Wang Y, Hu J, Lai J, Ma X, Chen J, Guan L, Wang G, Ma H, Liu Z. The mental health of medical workers in Wuhan, China dealing with the 2019 novel coronavirus. Lancet Psychiatry. 2020 Mar;7(3):e14. doi: 10.1016/S2215-0366(20)30047-X. Epub 2020 Feb 5. No abstract available.
- Background: PubMed 26847480Khalid I, Khalid TJ, Qabajah MR, Barnard AG, Qushmaq IA. Healthcare Workers Emotions, Perceived Stressors and Coping Strategies During a MERS-CoV Outbreak. Clin Med Res. 2016 Mar;14(1):7-14. doi: 10.3121/cmr.2016.1303. Epub 2016 Feb 4.
- Background: PubMed 32226291Li W, Yang Y, Liu ZH, Zhao YJ, Zhang Q, Zhang L, Cheung T, Xiang YT. Progression of Mental Health Services during the COVID-19 Outbreak in China. Int J Biol Sci. 2020 Mar 15;16(10):1732-1738. doi: 10.7150/ijbs.45120. eCollection 2020.
- Background: PubMed 28596148Mira JJ, Carrillo I, Guilabert M, Lorenzo S, Perez-Perez P, Silvestre C, Ferrus L; Spanish Second Victim Research Team. The Second Victim Phenomenon After a Clinical Error: The Design and Evaluation of a Website to Reduce Caregivers' Emotional Responses After a Clinical Error. J Med Internet Res. 2017 Jun 8;19(6):e203. doi: 10.2196/jmir.7840.
- Background: PubMed 25886369Mira JJ, Carrillo I, Lorenzo S, Ferrus L, Silvestre C, Perez-Perez P, Olivera G, Iglesias F, Zavala E, Maderuelo-Fernandez JA, Vitaller J, Nuno-Solinis R, Astier P; Research Group on Second and Third Victims. The aftermath of adverse events in Spanish primary care and hospital health professionals. BMC Health Serv Res. 2015 Apr 9;15:151. doi: 10.1186/s12913-015-0790-7.
- Background: PubMed 18459528Mitchell JT. Innovative, precise, and descriptive terms for group crisis support services: a United Nations initiative. Int J Emerg Ment Health. 2007 Fall;9(4):247-52.
- Background: PubMed 20480757Scott SD, Hirschinger LE, Cox KR, McCoig M, Hahn-Cover K, Epperly KM, Phillips EC, Hall LW. Caring for our own: deploying a systemwide second victim rapid response team. Jt Comm J Qual Patient Saf. 2010 May;36(5):233-40. doi: 10.1016/s1553-7250(10)36038-7.
- Background: PubMed 19497162Wu P, Fang Y, Guan Z, Fan B, Kong J, Yao Z, Liu X, Fuller CJ, Susser E, Lu J, Hoven CW. The psychological impact of the SARS epidemic on hospital employees in China: exposure, risk perception, and altruistic acceptance of risk. Can J Psychiatry. 2009 May;54(5):302-11. doi: 10.1177/070674370905400504.
- Background: PubMed 32032543Xiang YT, Yang Y, Li W, Zhang L, Zhang Q, Cheung T, Ng CH. Timely mental health care for the 2019 novel coronavirus outbreak is urgently needed. Lancet Psychiatry. 2020 Mar;7(3):228-229. doi: 10.1016/S2215-0366(20)30046-8. Epub 2020 Feb 4. No abstract available.
- Be+ Against COVID Second Victims working group websiteLink provided by the sponsor.
- EASE Scale pre-printLink provided by the sponsor.
- 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.
Jose J Mira, PhD principal investigator
Universidad Miguel Hernández de Elche.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stress Disorder, run by Universidad Miguel Hernandez de Elche at 5 sites in 5 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 1 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: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Argentina, Chile, Colombia, Ecuador, Spain. 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?
Prevalence of Acute Stress (time frame: 15 days). 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 NCT04486404, which also lists 14 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 19 Sep 2022.