- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04426266
Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population
September 28, 2020 updated by: Szeged University
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
441
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Szeged, Hungary, 6720
- University of Szeged Department of Dermatology and Allergology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adult Hungarian
Description
Inclusion Criteria:
The participant must have access to the internet and to the social media website Facebook.
Exclusion Criteria:
none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sociodemopraphic factors
Time Frame: 5 months
|
6 items - age, sex, city of residence, marital status, level of education, employment status
|
5 months
|
perceived stress
Time Frame: 5 months
|
Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress
|
5 months
|
level of anxiety
Time Frame: 5 months
|
The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety
|
5 months
|
self-reported health state
Time Frame: 5 months
|
EQ5D-VAS, 1 item to examine health status
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5 months
|
number of complaints
Time Frame: 5 months
|
Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.
|
5 months
|
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
|
5 months
|
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).
|
5 months
|
level of depression
Time Frame: 5 months
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The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression
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5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lajos Kemény, Prof. Dr., University of Szeged, Department of Dermatology and Allergology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wang 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.
- 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.
- Ho 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Actual)
September 28, 2020
Study Completion (Actual)
September 28, 2020
Study Registration Dates
First Submitted
June 8, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 28, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Anxiety Disorders
- Stress, Psychological
Other Study ID Numbers
- PSZ-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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