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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04426266
Other study ID # PSZ-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date September 28, 2020

Study information

Verified date June 2020
Source Szeged University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. With these results it will possible to identify coping strategies that can help Hungarian adults to deal with the difficulties arising from the pandemic.


Description:

Planned course of the project:

1. We make the questionnaire using Google Forms.

2. The link of the online questionnaire is sent to three public groups via the social media website Facebook.

3. 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.

4. Anonymous answers will be automatically saved.

5. The participants will be given code numbers based on the order in which they filled out the questionnaire.

6. The data will be analysed by the researchers. For a participant, completing the online questionnaire takes approximately 10-15 minutes.


Recruitment information / eligibility

Status Completed
Enrollment 441
Est. completion date September 28, 2020
Est. primary completion date September 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

The participant must have access to the internet and to the social media website Facebook.

Exclusion Criteria:

none

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Hungary University of Szeged Department of Dermatology and Allergology Szeged

Sponsors (1)

Lead Sponsor Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

References & Publications (3)

Ho CS, Chee CY, Ho RC. Mental Health Strategies to Combat the Psychological Impact of COVID-19 Beyond Paranoia and Panic. Ann Acad Med Singap. 2020 Mar 16;49(3):155-160. — View Citation

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). pii: E1729. doi: 10.3390/ijerph17051729. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary sociodemopraphic factors 6 items - age, sex, city of residence, marital status, level of education, employment status 5 months
Primary perceived stress Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress 5 months
Primary level of anxiety The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety 5 months
Primary self-reported health state EQ5D-VAS, 1 item to examine health status 5 months
Primary number of complaints Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints. 5 months
Primary 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 5 months
Primary 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). 5 months
Primary level of depression The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression 5 months
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