Depression, AnxietyNCT04961372
Socio-psychological Status of Healthcare Workers During SARS-CoV2 Pandemic
An observational study of Depression, Anxiety, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Survey
- How many people
- 333 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 30 Sep 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All healthcare workers aged between 18-65 who works at Siran Government Hospital (111 volunteers) and 222 healthy volunteers who are non-healthcare workers.
Who may be able to join
- All healthcare workers aged between 18-65 who works at Siran Government Hospital
Who cannot join
- Participants who did not agree to participate in the study
- Uncooperative participants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Siran Government Hospital
Gümüşhane, Siran, 29700
About this study
The aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.
Read the detailed description
Severe Acute Respiratory Syndrome - Corona Virus 2 (SARS-CoV2) was detected by the Chinese Center for Disease Control and Prevention on 7 January 2020 in a patient with atypical pneumonia in Wuhan, China, via a nasopharyngeal swab. On March 11, 2020, the World Health Organization declared it a "Pandemic". SARS-CoV2 quickly turned into a global epidemic, with a total of 134,957,021 confirmed cases and 2,918,752 deaths reported in April 2021.Since SARS-CoV2 is a highly contagious disease, the risk of infection in healthcare workers is quite high. In one of the earliest studies in Wuhan, 29 percent of patients (40 out of 138) were reported to be healthcare workers. A report from the American Centers for Disease Control and Prevention (CDC) stated that a total of 9,282 healthcare workers were diagnosed with COVID-19, including 27 deaths, between February 12 and April 9, 2020. Eleven to nineteen percent of COVID-19 cases have been identified as healthcare professionals.As the investigators have seen in studies of SARS or Ebola outbreaks, the sudden onset of an immediately life-threatening epidemic can place an extraordinary amount of pressure on healthcare workers. Increased workload, physical fatigue, inadequate personal equipment, nosocomial transmission, and having to make ethically difficult decisions can have dramatic effects on their physical and mental health. The weight of working conditions together with the risk of illness of their social environment and families can cause mental health problems such as fear and anxiety in healthcare workers.When an effective vaccination program is in place, population uptake should be as high as possible to achieve herd immunity. Vaccination hesitancy, defined as a delay in acceptance or rejection of vaccination despite the availability of vaccination services, is one of the barriers to this. It is a complex special case that varies with time, place, and vaccines. It is influenced by factors such as peace of mind, convenience, and trust. Vaccine hesitations have been identified as one of the ten global health threats of 2019.The aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.
- Conditions
- Depression, Anxiety
- Being tested
- Survey
- Keywords
- Depression, Anxiety, Healthcare Workers
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
PHQ9 Depression Scale for evaluating depression, GAD7 Anxiety Score for evaluating anxiety, WSAS Score for evaluating Work and Social Adjustment
| Study group | Role | What they receive |
|---|---|---|
| Healthcare Workers | All healthcare professionals working at Gümüşhane Şiran Government Hospital Receives: Other: Survey | |
| Non-Healthcare Workers | Twice the number of health workers included in the study, non-health worker volunteers Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 Score
Depression Score.1-4 Minimal depression,5-9 Mild depression,10-14 Moderate depression,15-19 Moderately severe depression,20-27 Severe depression
Measured: 6 Months
Generalised Anxiety Disorder Assessment Score
Anxiety Score. 0-4: minimal anxiety,5-9: mild anxiety,10-14: moderate anxiety,15-21: severe anxiety
Measured: 6 Months
Work and Social Adjustment Score
Work and Social Adjustment Score. WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology. Scores below 10 appear to be associated with subclinical populations
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 posted14 Jul 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Gokalp TAS, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961372
- Sponsor's protocol ID
- ErzincanUniversity
- Status last verified
- Mar 2022
- First submitted
- 1 Jul 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264WHO. WHO Coronavirus (COVID-19) Dashboard [Web Page]. 2021 [updated 11.04.2021. WHO Coronavirus (COVID-19) Dashboard]. Available from: https://covid19.who.int/.
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570CDC COVID-19 Response Team. Characteristics of Health Care Personnel with COVID-19 - United States, February 12-April 9, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):477-481. doi: 10.15585/mmwr.mm6915e6.
PubMed 32298247Liu X, Kakade M, Fuller CJ, Fan B, Fang Y, Kong J, Guan Z, Wu P. Depression after exposure to stressful events: lessons learned from the severe acute respiratory syndrome epidemic. Compr Psychiatry. 2012 Jan;53(1):15-23. doi: 10.1016/j.comppsych.2011.02.003. Epub 2011 Apr 12.
PubMed 21489421Lung FW, Lu YC, Chang YY, Shu BC. Mental Symptoms in Different Health Professionals During the SARS Attack: A Follow-up Study. Psychiatr Q. 2009 Jun;80(2):107-16. doi: 10.1007/s11126-009-9095-5. Epub 2009 Feb 27.
PubMed 19247834Wu 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 19497162Fontanet A, Cauchemez S. COVID-19 herd immunity: where are we? Nat Rev Immunol. 2020 Oct;20(10):583-584. doi: 10.1038/s41577-020-00451-5.
PubMed 32908300Ashby B, Best A. Herd immunity. Curr Biol. 2021 Feb 22;31(4):R174-R177. doi: 10.1016/j.cub.2021.01.006. Epub 2021 Jan 12.
PubMed 33621500Swaminathan S. The WHO's chief scientist on a year of loss and learning. Nature. 2020 Dec;588(7839):583-585. doi: 10.1038/d41586-020-03556-y. No abstract available.
PubMed 33335314MacDonald NE; SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161-4. doi: 10.1016/j.vaccine.2015.04.036. Epub 2015 Apr 17.
PubMed 25896383Thangaraju P, Venkatesan SJCMJ. WHO Ten threats to global health in 2019: Antimicrobial resistance. 2019;44(3):1150-1.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socio-psychological Status of Healthcare Workers During SARS-CoV2 Pandemic
- ClinicalTrials.gov ID
- NCT04961372
- Acronym / sponsor ID
- ErzincanUniversity
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety, Healthcare Workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 14 Jul 2021 (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 aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.
Detailed description
Severe Acute Respiratory Syndrome - Corona Virus 2 (SARS-CoV2) was detected by the Chinese Center for Disease Control and Prevention on 7 January 2020 in a patient with atypical pneumonia in Wuhan, China, via a nasopharyngeal swab. On March 11, 2020, the World Health Organization declared it a "Pandemic". SARS-CoV2 quickly turned into a global epidemic, with a total of 134,957,021 confirmed cases and 2,918,752 deaths reported in April 2021.Since SARS-CoV2 is a highly contagious disease, the risk of infection in healthcare workers is quite high. In one of the earliest studies in Wuhan, 29 percent of patients (40 out of 138) were reported to be healthcare workers. A report from the American Centers for Disease Control and Prevention (CDC) stated that a total of 9,282 healthcare workers were diagnosed with COVID-19, including 27 deaths, between February 12 and April 9, 2020. Eleven to nineteen percent of COVID-19 cases have been identified as healthcare professionals.As the investigators have seen in studies of SARS or Ebola outbreaks, the sudden onset of an immediately life-threatening epidemic can place an extraordinary amount of pressure on healthcare workers. Increased workload, physical fatigue, inadequate personal equipment, nosocomial transmission, and having to make ethically difficult decisions can have dramatic effects on their physical and mental health. The weight of working conditions together with the risk of illness of their social environment and families can cause mental health problems such as fear and anxiety in healthcare workers.When an effective vaccination program is in place, population uptake should be as high as possible to achieve herd immunity. Vaccination hesitancy, defined as a delay in acceptance or rejection of vaccination despite the availability of vaccination services, is one of the barriers to this. It is a complex special case that varies with time, place, and vaccines. It is influenced by factors such as peace of mind, convenience, and trust. Vaccine hesitations have been identified as one of the ten global health threats of 2019.The aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare Workers | – | Other: SurveyAll healthcare professionals working at Gümüşhane Şiran Government Hospital |
| Non-Healthcare Workers | – | Other: SurveyTwice the number of health workers included in the study, non-health worker volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All healthcare workers aged between 18-65 who works at Siran Government Hospital (111 volunteers) and 222 healthy volunteers who are non-healthcare workers.
Key inclusion criteria (1 listed)
- All healthcare workers aged between 18-65 who works at Siran Government Hospital
Key exclusion criteria (2 listed)
- Participants who did not agree to participate in the study
- Uncooperative participants
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 |
|---|---|---|
| SurveyPHQ9 Depression Scale for evaluating depression, GAD7 Anxiety Score for evaluating anxiety, WSAS Score for evaluating Work and Social Adjustment | Other | Healthcare Workers, Non-Healthcare Workers |
Primary outcome
Patient Health Questionnaire-9 Score
Time frame: 6 Months
Depression Score.1-4 Minimal depression,5-9 Mild depression,10-14 Moderate depression,15-19 Moderately severe depression,20-27 Severe depression
Generalised Anxiety Disorder Assessment Score
Time frame: 6 Months
Anxiety Score. 0-4: minimal anxiety,5-9: mild anxiety,10-14: moderate anxiety,15-21: severe anxiety
Work and Social Adjustment Score
Time frame: 6 Months
Work and Social Adjustment Score. WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology. Scores below 10 appear to be associated with subclinical populations
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 23 Mar 2022.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- BackgroundWHO. WHO Coronavirus (COVID-19) Dashboard [Web Page]. 2021 [updated 11.04.2021. WHO Coronavirus (COVID-19) Dashboard]. Available from: https://covid19.who.int/.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 32298247CDC COVID-19 Response Team. Characteristics of Health Care Personnel with COVID-19 - United States, February 12-April 9, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):477-481. doi: 10.15585/mmwr.mm6915e6.
- Background: PubMed 21489421Liu X, Kakade M, Fuller CJ, Fan B, Fang Y, Kong J, Guan Z, Wu P. Depression after exposure to stressful events: lessons learned from the severe acute respiratory syndrome epidemic. Compr Psychiatry. 2012 Jan;53(1):15-23. doi: 10.1016/j.comppsych.2011.02.003. Epub 2011 Apr 12.
- Background: PubMed 19247834Lung FW, Lu YC, Chang YY, Shu BC. Mental Symptoms in Different Health Professionals During the SARS Attack: A Follow-up Study. Psychiatr Q. 2009 Jun;80(2):107-16. doi: 10.1007/s11126-009-9095-5. Epub 2009 Feb 27.
- 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 32908300Fontanet A, Cauchemez S. COVID-19 herd immunity: where are we? Nat Rev Immunol. 2020 Oct;20(10):583-584. doi: 10.1038/s41577-020-00451-5.
- Background: PubMed 33621500Ashby B, Best A. Herd immunity. Curr Biol. 2021 Feb 22;31(4):R174-R177. doi: 10.1016/j.cub.2021.01.006. Epub 2021 Jan 12.
- Background: PubMed 33335314Swaminathan S. The WHO's chief scientist on a year of loss and learning. Nature. 2020 Dec;588(7839):583-585. doi: 10.1038/d41586-020-03556-y. No abstract available.
- Background: PubMed 25896383MacDonald NE; SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161-4. doi: 10.1016/j.vaccine.2015.04.036. Epub 2015 Apr 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety, run by Erzincan University at 1 site in Turkey (Türkiye).
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 2 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 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Patient Health Questionnaire-9 Score (time frame: 6 Months). The study lists 3 primary outcomes in all. 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 NCT04961372, which also lists 13 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 23 Mar 2022.