<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426266</url>
  </required_header>
  <id_info>
    <org_study_id>PSZ-002</org_study_id>
    <nct_id>NCT04426266</nct_id>
  </id_info>
  <brief_title>Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population</brief_title>
  <official_title>Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szeged University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to explore the psychological effects of the COVID-19 pandemic among&#xD;
      Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items.&#xD;
      With these results it will possible to identify coping strategies that can help Hungarian&#xD;
      adults to deal with the difficulties arising from the pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Planned course of the project:&#xD;
&#xD;
        1. We make the questionnaire using Google Forms.&#xD;
&#xD;
        2. The link of the online questionnaire is sent to three public groups via the social media&#xD;
           website Facebook.&#xD;
&#xD;
        3. By clicking on the sent link, all participants are able to read information about the&#xD;
           project and about the consent to participate in it. Then the participant will be able to&#xD;
           give consent to participate in the project. After giving consent, the participant will&#xD;
           be able to start filling out the questionnaire. If the participant indicates that he/she&#xD;
           does not want to give consent to the study, the website will indicate that the&#xD;
           participation of him/her has ended in the project.&#xD;
&#xD;
        4. Anonymous answers will be automatically saved.&#xD;
&#xD;
        5. The participants will be given code numbers based on the order in which they filled out&#xD;
           the questionnaire.&#xD;
&#xD;
        6. The data will be analysed by the researchers. For a participant, completing the online&#xD;
           questionnaire takes approximately 10-15 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">September 28, 2020</completion_date>
  <primary_completion_date type="Actual">September 28, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>sociodemopraphic factors</measure>
    <time_frame>5 months</time_frame>
    <description>6 items - age, sex, city of residence, marital status, level of education, employment status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>perceived stress</measure>
    <time_frame>5 months</time_frame>
    <description>Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>level of anxiety</measure>
    <time_frame>5 months</time_frame>
    <description>The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>self-reported health state</measure>
    <time_frame>5 months</time_frame>
    <description>EQ5D-VAS, 1 item to examine health status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of complaints</measure>
    <time_frame>5 months</time_frame>
    <description>Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>strategies in coping with stressful situations</measure>
    <time_frame>5 months</time_frame>
    <description>Shortened (Hungarian) version of the Ways of Coping Questionnaire (WOC), 22 items to measure cognitive or behavioral strategies in coping with stressful situations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic</measure>
    <time_frame>5 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>level of depression</measure>
    <time_frame>5 months</time_frame>
    <description>The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression</description>
  </primary_outcome>
  <enrollment type="Actual">441</enrollment>
  <condition>Questionnaire Designs</condition>
  <condition>COVID-19 Pandemic</condition>
  <condition>Psychological Stress</condition>
  <condition>Coping Skills</condition>
  <condition>Two-Item Generalised Anxiety Disorder Scale</condition>
  <condition>Patient Health Questionnaire Anxiety and Depression Scale</condition>
  <condition>Health Status Index</condition>
  <condition>Subjective Health Complaint</condition>
  <condition>Mood</condition>
  <eligibility>
    <study_pop>
      <textblock>
        adult Hungarian&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The participant must have access to the internet and to the social media website Facebook.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lajos Kemény, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Szeged, Department of Dermatology and Allergology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Szeged Department of Dermatology and Allergology</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <reference>
    <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. No abstract available.</citation>
    <PMID>32093461</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>32200399</PMID>
  </reference>
  <reference>
    <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):1729. doi: 10.3390/ijerph17051729.</citation>
    <PMID>32155789</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426266
org study id: PSZ-002
nct id: NCT04426266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: sociodemopraphic factors
time frame: 5 months
description: 6 items - age, sex, city of residence, marital status, level of education, employment status
measure: perceived stress
time frame: 5 months
description: Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress
measure: level of anxiety
time frame: 5 months
description: The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety
measure: self-reported health state
time frame: 5 months
description: EQ5D-VAS, 1 item to examine health status
measure: number of complaints
time frame: 5 months
description: Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.
measure: strategies in coping with stressful situations
time frame: 5 months
description: Shortened (Hungarian) version of the Ways of Coping Questionnaire (WOC), 22 items to measure cognitive or behavioral strategies in coping with stressful situations
measure: psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic
time frame: 5 months
description: 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).
measure: level of depression
time frame: 5 months
description: The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lajos Kemény, Prof. Dr.
role: Principal Investigator
affiliation: University of Szeged, Department of Dermatology and Allergology
facility: 
country: Hungary
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. No abstract available.
PMID: 32093461
citation: 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.
PMID: 32200399
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):1729. doi: 10.3390/ijerph17051729.
PMID: 32155789
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Anxiety Disorders
mesh term: Stress, Psychological
sharing ipd: No