Questionnaire DesignsNCT04426266
Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population
An observational study of Questionnaire Designs and COVID-19 Pandemic, run by Szeged University at 1 site in Hungary.
Trial summary
The aim of the study is to explore the psychological effects of the COVID-19 pandemic among Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Questionnaire Designs, COVID-19 Pandemic, Psychological Stress
- How many people
- 441 participants
- Where
- 1 siteHungary
- Study dates
- 1 May 2020to 28 Sep 2020
- 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: adult Hungarian
Who may be able to join
- The participant must have access to the internet and to the social media website Facebook.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Szeged Department of Dermatology and Allergology
Szeged, 6720
About this study
The aim of the study is to explore the psychological effects of the COVID-19 pandemic among Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items. With these results it will possible to identify coping strategies that can help Hungarian adults to deal with the difficulties arising from the pandemic.
Read the detailed description
Planned course of the project:
- We make the questionnaire using Google Forms.
- The link of the online questionnaire is sent to three public groups via the social media website Facebook.
- By clicking on the sent link, all participants are able to read information about the project and about the consent to participate in it. Then the participant will be able to give consent to participate in the project. After giving consent, the participant will be able to start filling out the questionnaire. If the participant indicates that he/she does not want to give consent to the study, the website will indicate that the participation of him/her has ended in the project.
- Anonymous answers will be automatically saved.
- The participants will be given code numbers based on the order in which they filled out the questionnaire.
- The data will be analysed by the researchers. For a participant, completing the online questionnaire takes approximately 10-15 minutes.
- Conditions
- Questionnaire Designs, COVID-19 Pandemic, Psychological Stress, Coping Skills, Two-Item Generalised Anxiety Disorder Scale, Patient Health Questionnaire Anxiety and Depression Scale
- Medical subject headings
- COVID-19, Stress, Psychological, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
sociodemopraphic factors
6 items - age, sex, city of residence, marital status, level of education, employment status
Measured: 5 months
perceived stress
Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress
Measured: 5 months
level of anxiety
The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety
Measured: 5 months
self-reported health state
EQ5D-VAS, 1 item to examine health status
Measured: 5 months
number of complaints
Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.
Measured: 5 months
strategies in coping with stressful situations
Shortened (Hungarian) version of the Ways of Coping Questionnaire (WOC), 22 items to measure cognitive or behavioral strategies in coping with stressful situations
Measured: 5 months
psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic
psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic, 2 open-ended questions (not obligatory to answer) in connection with psychological effects of the coronavirus pandemic (its effects on the participants' mood and ways of coping with difficulties arising from the pandemic).
Measured: 5 months
level of depression
The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 May 2020
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Questionnaire DesignsStudies 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
- Cross-sectional
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lajos Kemény, Prof. Dr., Principal investigator, University of Szeged, Department of Dermatology and Allergology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426266
- Sponsor's protocol ID
- PSZ-002
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiao C. A Novel Approach of Consultation on 2019 Novel Coronavirus (COVID-19)-Related Psychological and Mental Problems: Structured Letter Therapy. Psychiatry Investig. 2020 Feb;17(2):175-176. doi: 10.30773/pi.2020.0047. Epub 2020 Feb 25. No abstract available.
PubMed 32093461Ho CS, Chee CY, Ho RC. Mental Health Strategies to Combat the Psychological Impact of Coronavirus Disease 2019 (COVID-19) Beyond Paranoia and Panic. Ann Acad Med Singap. 2020 Mar 16;49(3):155-160. No abstract available.
PubMed 32200399Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.
PubMed 32155789
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population
- ClinicalTrials.gov ID
- NCT04426266
- Acronym / sponsor ID
- PSZ-002
- Conditions
- Questionnaire Designs, COVID-19 Pandemic, Psychological Stress, Coping Skills, Two-Item Generalised Anxiety Disorder Scale, Patient Health Questionnaire Anxiety and Depression Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 11 Jun 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 aim of the study is to explore the psychological effects of the COVID-19 pandemic among Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items. With these results it will possible to identify coping strategies that can help Hungarian adults to deal with the difficulties arising from the pandemic.
Detailed description
Planned course of the project:
- We make the questionnaire using Google Forms.
- The link of the online questionnaire is sent to three public groups via the social media website Facebook.
- By clicking on the sent link, all participants are able to read information about the project and about the consent to participate in it. Then the participant will be able to give consent to participate in the project. After giving consent, the participant will be able to start filling out the questionnaire. If the participant indicates that he/she does not want to give consent to the study, the website will indicate that the participation of him/her has ended in the project.
- Anonymous answers will be automatically saved.
- The participants will be given code numbers based on the order in which they filled out the questionnaire.
- The data will be analysed by the researchers. For a participant, completing the online questionnaire takes approximately 10-15 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult Hungarian
Key inclusion criteria (1 listed)
- The participant must have access to the internet and to the social media website Facebook.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sociodemopraphic factors
Time frame: 5 months
6 items - age, sex, city of residence, marital status, level of education, employment status
perceived stress
Time frame: 5 months
Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress
level of anxiety
Time frame: 5 months
The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety
self-reported health state
Time frame: 5 months
EQ5D-VAS, 1 item to examine health status
number of complaints
Time frame: 5 months
Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.
strategies in coping with stressful situations
Time frame: 5 months
Shortened (Hungarian) version of the Ways of Coping Questionnaire (WOC), 22 items to measure cognitive or behavioral strategies in coping with stressful situations
psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic
Time frame: 5 months
psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic, 2 open-ended questions (not obligatory to answer) in connection with psychological effects of the coronavirus pandemic (its effects on the participants' mood and ways of coping with difficulties arising from the pandemic).
level of depression
Time frame: 5 months
The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression
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 29 Sep 2020.
- Background: PubMed 32093461Xiao C. A Novel Approach of Consultation on 2019 Novel Coronavirus (COVID-19)-Related Psychological and Mental Problems: Structured Letter Therapy. Psychiatry Investig. 2020 Feb;17(2):175-176. doi: 10.30773/pi.2020.0047. Epub 2020 Feb 25. No abstract available.
- Background: PubMed 32200399Ho CS, Chee CY, Ho RC. Mental Health Strategies to Combat the Psychological Impact of Coronavirus Disease 2019 (COVID-19) Beyond Paranoia and Panic. Ann Acad Med Singap. 2020 Mar 16;49(3):155-160. No abstract available.
- Background: PubMed 32155789Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.
- Individual participant dataSharing planned: No
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.
Lajos Kemény, Prof. Dr. principal investigator
University of Szeged, Department of Dermatology and Allergology
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 Questionnaire Designs and COVID-19 Pandemic, run by Szeged University at 1 site in Hungary.
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 29 Sep 2020. 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 Hungary. 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?
sociodemopraphic factors (time frame: 5 months). The study lists 8 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 NCT04426266, which also lists 3 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 29 Sep 2020.