<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/NCT04459403</url>
  </required_header>
  <id_info>
    <org_study_id>15-2020/1</org_study_id>
    <nct_id>NCT04459403</nct_id>
  </id_info>
  <brief_title>Psychiatric Disturbances and COVID-19 Infection</brief_title>
  <official_title>Psychiatric Disturbances in Patients Infected With COVID-19: A Cross Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health and Population, Egypt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Hepatology &amp; Tropical Medicine Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <brief_summary>
    <textblock>
      This observational study aims at Assessment of the prevalence and types Psychiatric&#xD;
      disturbances that affects patients with COVID-19 infection with and without previous&#xD;
      psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in&#xD;
      patients with COVID-19 infection in correlation to age, disease severity, co-morbid&#xD;
      conditions and treatments applied&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      International outbreak of the novel coronavirus (2019- nCoV) raised intense attention of&#xD;
      specialists worldwide, including psychiatrists. The five stages of shock-denial, anger,&#xD;
      bargaining, depression, and acceptance are experienced by many patients. Coronaphobia is a&#xD;
      novel term referring to excessive fear of being infected by coronavirus. The current pandemic&#xD;
      necessitates research in different areas of psychiatry, including psychosocial and&#xD;
      pharmacological interventions to find evidence-based ways of treatment.&#xD;
&#xD;
      This is a multi-center observational cross-sectional study with consecutive sample that will&#xD;
      include patients quarantined due to COVID-19 infection. Adult Patients will be recruited&#xD;
      consecutively (convenient sample). Data will be collected from patients in the form of:&#xD;
&#xD;
      Demographic data e.g. Age, Gender, Smoking history, exposure to source transmission&#xD;
      Co-morbidities e.g. underlying chronic liver, lung, cardiac or kidney diseases, diabetes&#xD;
      mellitus, hypertension Severity of COVID-19 infection: mild, moderate or severe&#xD;
&#xD;
      Psychiatric assessment of patients:&#xD;
&#xD;
      Patients will be subjected to the following questionnaires:&#xD;
&#xD;
        1. The General Health Questionnaire (GHQ-12), Arabic version:&#xD;
&#xD;
           It is the most extensively used screening instrument for common mental disorders, in&#xD;
           addition to being a more general measure of psychiatric well-being. It asks whether the&#xD;
           respondent has experienced a particular symptom or behavior recently. Each item is rated&#xD;
           on a four-point scale (less than usual, no more than usual, rather more than usual, or&#xD;
           much more than usual); it gives a total score of 36 based on the Likert scoring styles&#xD;
           (0-1-2-3). It is a brief, simple, easy to complete, and its application in research&#xD;
           settings as a screening tool is well documented. GHQ-12 is a consistent and reliable&#xD;
           instrument when used in general population samples.&#xD;
&#xD;
        2. Taylor Manifest Anxiety Scale , Arabic version:&#xD;
&#xD;
           A person answers by reflecting on themselves, in order to determine their anxiety level.&#xD;
           It is used to separate normal participants from those who would be considered to have&#xD;
           pathological anxiety levels. It consists of 50 true or false questions. It has been&#xD;
           proven reliable using test-retest reliability. O'Connor, Lorr, and Stafford found there&#xD;
           were five general factors in the scale: chronic anxiety or worry, increased&#xD;
           physiological reactivity, sleep disturbances associated with inner strain, sense of&#xD;
           personal inadequacy, and motor tension .&#xD;
&#xD;
        3. Beck Depression Inventory (BDI) , Arabic version:&#xD;
&#xD;
           It is a self-report scale designed to assess symptoms of depression such as sadness,&#xD;
           guilt, loss of interest, social withdrawal, increase and decrease in appetite or sleep,&#xD;
           suicidal ideation, and other behavioral manifestations of depression over the previous 2&#xD;
           weeks. It can also be used over time to monitor symptoms and to assess response to&#xD;
           therapeutic interventions. The inventory is composed of 21 groups of statements on a&#xD;
           four-point scale with the patient selecting the one that best matches his or her current&#xD;
           state.&#xD;
&#xD;
        4. The Brief-COPE scale , Arabic version :&#xD;
&#xD;
      It is an abbreviated version of the COPE (Coping Orientation to Problems Experienced)&#xD;
      Inventory. It is a self-report questionnaire developed to assess a broad range of coping&#xD;
      responses. It is one of the best validated and most frequently used measures of coping&#xD;
      strategies. The instrument consists of 28 items that measure 14 factors of 2 items each,&#xD;
      which correspond to a Likert scale ranged from 0 - 3.&#xD;
&#xD;
      from each center included in this study there is a person responsible for checking&#xD;
      completeness of the collected questionnaires&#xD;
&#xD;
      Statistical Analysis Results will be evaluated statistically by the Statistical Package for&#xD;
      the Social Sciences (SPSS) version 20 (IBM, 2011). Normality of data will be tested by&#xD;
      Kolmogorov-Smirnov test. To describe the data, frequency (percent) and mean± SD will be used.&#xD;
      T-test and Pearson correlation test will be used for comparisons and correlations&#xD;
      respectively for normally distributed data. Mann-Whitney U test and Spearman correlation test&#xD;
      will be used for comparisons and correlations respectively for non-normally distributed data.&#xD;
      P-values less than 0.05 will be considered statistically significant and 95 % Confidence&#xD;
      interval (CI) will be calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Psychiatric well-being, level of anxiety, symptoms of depression and coping strategies questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>The General Health Questionnaire: To measure psychiatric well-being. Taylor Manifest Anxiety Scale: To determine the level of anxiety. Beck Depression Inventory: To assess symptoms of depression. The Brief-COPE scale: To assess coping responses. These questionnaires are combined in one questionnaire filled by the patients. it needs from 15-20 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence and types of Psychiatric disturbances in patients with COVID-19 infection</measure>
    <time_frame>3 months</time_frame>
    <description>prevalence of each type and correlation with age, disease severity, co-morbid conditions and treatments applied</description>
  </primary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Corona Virus Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with confirmed COVID-19 infection by real time PCR quarantined at isolation&#xD;
        hospitals of the Egyptian Ministry of health and population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed cases with COVID-19 defined as a positive result to real-time&#xD;
             reverse-transcriptase polymerase-chain-reaction (RT-PCR) assay for nasal and&#xD;
             pharyngeal swab specimens&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to be included in the research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hend I Shousha, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>15 Mayo Smart Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National hepatology and tropical medicine research institute</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Students hospital</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Asmundson GJG, Taylor S. Coronaphobia: Fear and the 2019-nCoV outbreak. J Anxiety Disord. 2020 Mar;70:102196. doi: 10.1016/j.janxdis.2020.102196. Epub 2020 Feb 10. No abstract available.</citation>
    <PMID>32078967</PMID>
  </reference>
  <reference>
    <citation>Huang Y, Zhao N. Generalized anxiety disorder, depressive symptoms and sleep quality during COVID-19 outbreak in China: a web-based cross-sectional survey. Psychiatry Res. 2020 Jun;288:112954. doi: 10.1016/j.psychres.2020.112954. Epub 2020 Apr 12. Erratum In: Psychiatry Res. 2021 May;299:113803.</citation>
    <PMID>32325383</PMID>
  </reference>
  <reference>
    <citation>Daradkeh TK, Ghubash R, el-Rufaie OE. Reliability, validity, and factor structure of the Arabic version of the 12-item General Health Questionnaire. Psychol Rep. 2001 Aug;89(1):85-94. doi: 10.2466/pr0.2001.89.1.85.</citation>
    <PMID>11729557</PMID>
  </reference>
  <reference>
    <citation>Pevalin DJ. Multiple applications of the GHQ-12 in a general population sample: an investigation of long-term retest effects. Soc Psychiatry Psychiatr Epidemiol. 2000 Nov;35(11):508-12. doi: 10.1007/s001270050272.</citation>
    <PMID>11197926</PMID>
  </reference>
  <reference>
    <citation>TAYLOR JA. A personality scale of manifest anxiety. J Abnorm Psychol. 1953 Apr;48(2):285-90. doi: 10.1037/h0056264. No abstract available.</citation>
    <PMID>13052352</PMID>
  </reference>
  <reference>
    <citation>Fahmi M, Ghali M. Arabic version of Taylor Manifest Anxiety Scale. Egypt Psychiatr 1997; 11:119-126</citation>
  </reference>
  <reference>
    <citation>Nawel H, Elisabeth S. Adaptation and validation of the Tunisian version of the Brief COPE Scale. Eur Health Psychol. 2015; 17: 783</citation>
  </reference>
  <reference>
    <citation>Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available. Erratum In: Lancet. 2020 Jan 29;:</citation>
    <PMID>31986257</PMID>
  </reference>
  <reference>
    <citation>Yoo JH. The Fight against the 2019-nCoV Outbreak: an Arduous March Has Just Begun. J Korean Med Sci. 2020 Feb 3;35(4):e56. doi: 10.3346/jkms.2020.35.e56. No abstract available.</citation>
    <PMID>31997618</PMID>
  </reference>
  <reference>
    <citation>Huang 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. Erratum In: Lancet. 2020 Jan 30;:</citation>
    <PMID>31986264</PMID>
  </reference>
  <reference>
    <citation>Xu J, Zheng Y, Wang M, Zhao J, Zhan Q, Fu M, Wang Q, Xiao J, Cheng Y. Predictors of symptoms of posttraumatic stress in Chinese university students during the 2009 H1N1 influenza pandemic. Med Sci Monit. 2011 Jul;17(7):PH60-4. doi: 10.12659/msm.881836.</citation>
    <PMID>21709644</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hend Ibrahim Shousha</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Psychiatric disturbances</keyword>
  <keyword>Egypt</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <!-- 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/NCT04459403
org study id: 15-2020/1
nct id: NCT04459403
lead sponsor: 
collaborator: 
collaborator: 
This observational study aims at Assessment of the prevalence and types Psychiatric
      disturbances that affects patients with COVID-19 infection with and without previous
      psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in
      patients with COVID-19 infection in correlation to age, disease severity, co-morbid
      conditions and treatments applied
International outbreak of the novel coronavirus (2019- nCoV) raised intense attention of
      specialists worldwide, including psychiatrists. The five stages of shock-denial, anger,
      bargaining, depression, and acceptance are experienced by many patients. Coronaphobia is a
      novel term referring to excessive fear of being infected by coronavirus. The current pandemic
      necessitates research in different areas of psychiatry, including psychosocial and
      pharmacological interventions to find evidence-based ways of treatment.

      This is a multi-center observational cross-sectional study with consecutive sample that will
      include patients quarantined due to COVID-19 infection. Adult Patients will be recruited
      consecutively (convenient sample). Data will be collected from patients in the form of:

      Demographic data e.g. Age, Gender, Smoking history, exposure to source transmission
      Co-morbidities e.g. underlying chronic liver, lung, cardiac or kidney diseases, diabetes
      mellitus, hypertension Severity of COVID-19 infection: mild, moderate or severe

      Psychiatric assessment of patients:

      Patients will be subjected to the following questionnaires:

        1. The General Health Questionnaire (GHQ-12), Arabic version:

           It is the most extensively used screening instrument for common mental disorders, in
           addition to being a more general measure of psychiatric well-being. It asks whether the
           respondent has experienced a particular symptom or behavior recently. Each item is rated
           on a four-point scale (less than usual, no more than usual, rather more than usual, or
           much more than usual); it gives a total score of 36 based on the Likert scoring styles
           (0-1-2-3). It is a brief, simple, easy to complete, and its application in research
           settings as a screening tool is well documented. GHQ-12 is a consistent and reliable
           instrument when used in general population samples.

        2. Taylor Manifest Anxiety Scale , Arabic version:

           A person answers by reflecting on themselves, in order to determine their anxiety level.
           It is used to separate normal participants from those who would be considered to have
           pathological anxiety levels. It consists of 50 true or false questions. It has been
           proven reliable using test-retest reliability. O'Connor, Lorr, and Stafford found there
           were five general factors in the scale: chronic anxiety or worry, increased
           physiological reactivity, sleep disturbances associated with inner strain, sense of
           personal inadequacy, and motor tension .

        3. Beck Depression Inventory (BDI) , Arabic version:

           It is a self-report scale designed to assess symptoms of depression such as sadness,
           guilt, loss of interest, social withdrawal, increase and decrease in appetite or sleep,
           suicidal ideation, and other behavioral manifestations of depression over the previous 2
           weeks. It can also be used over time to monitor symptoms and to assess response to
           therapeutic interventions. The inventory is composed of 21 groups of statements on a
           four-point scale with the patient selecting the one that best matches his or her current
           state.

        4. The Brief-COPE scale , Arabic version :

      It is an abbreviated version of the COPE (Coping Orientation to Problems Experienced)
      Inventory. It is a self-report questionnaire developed to assess a broad range of coping
      responses. It is one of the best validated and most frequently used measures of coping
      strategies. The instrument consists of 28 items that measure 14 factors of 2 items each,
      which correspond to a Likert scale ranged from 0 - 3.

      from each center included in this study there is a person responsible for checking
      completeness of the collected questionnaires

      Statistical Analysis Results will be evaluated statistically by the Statistical Package for
      the Social Sciences (SPSS) version 20 (IBM, 2011). Normality of data will be tested by
      Kolmogorov-Smirnov test. To describe the data, frequency (percent) and mean± SD will be used.
      T-test and Pearson correlation test will be used for comparisons and correlations
      respectively for normally distributed data. Mann-Whitney U test and Spearman correlation test
      will be used for comparisons and correlations respectively for non-normally distributed data.
      P-values less than 0.05 will be considered statistically significant and 95 % Confidence
      interval (CI) will be calculated.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Psychiatric well-being, level of anxiety, symptoms of depression and coping strategies questionnaire
time frame: 3 months
description: The General Health Questionnaire: To measure psychiatric well-being. Taylor Manifest Anxiety Scale: To determine the level of anxiety. Beck Depression Inventory: To assess symptoms of depression. The Brief-COPE scale: To assess coping responses. These questionnaires are combined in one questionnaire filled by the patients. it needs from 15-20 minutes.
measure: Prevalence and types of Psychiatric disturbances in patients with COVID-19 infection
time frame: 3 months
description: prevalence of each type and correlation with age, disease severity, co-morbid conditions and treatments applied
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hend I Shousha, M.D
role: Principal Investigator
affiliation: Cairo University
facility: 
facility: 
facility: 
country: Egypt
citation: Asmundson GJG, Taylor S. Coronaphobia: Fear and the 2019-nCoV outbreak. J Anxiety Disord. 2020 Mar;70:102196. doi: 10.1016/j.janxdis.2020.102196. Epub 2020 Feb 10. No abstract available.
PMID: 32078967
citation: Huang Y, Zhao N. Generalized anxiety disorder, depressive symptoms and sleep quality during COVID-19 outbreak in China: a web-based cross-sectional survey. Psychiatry Res. 2020 Jun;288:112954. doi: 10.1016/j.psychres.2020.112954. Epub 2020 Apr 12. Erratum In: Psychiatry Res. 2021 May;299:113803.
PMID: 32325383
citation: Daradkeh TK, Ghubash R, el-Rufaie OE. Reliability, validity, and factor structure of the Arabic version of the 12-item General Health Questionnaire. Psychol Rep. 2001 Aug;89(1):85-94. doi: 10.2466/pr0.2001.89.1.85.
PMID: 11729557
citation: Pevalin DJ. Multiple applications of the GHQ-12 in a general population sample: an investigation of long-term retest effects. Soc Psychiatry Psychiatr Epidemiol. 2000 Nov;35(11):508-12. doi: 10.1007/s001270050272.
PMID: 11197926
citation: TAYLOR JA. A personality scale of manifest anxiety. J Abnorm Psychol. 1953 Apr;48(2):285-90. doi: 10.1037/h0056264. No abstract available.
PMID: 13052352
citation: Fahmi M, Ghali M. Arabic version of Taylor Manifest Anxiety Scale. Egypt Psychiatr 1997; 11:119-126
citation: Nawel H, Elisabeth S. Adaptation and validation of the Tunisian version of the Brief COPE Scale. Eur Health Psychol. 2015; 17: 783
citation: Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available. Erratum In: Lancet. 2020 Jan 29;:
PMID: 31986257
citation: Yoo JH. The Fight against the 2019-nCoV Outbreak: an Arduous March Has Just Begun. J Korean Med Sci. 2020 Feb 3;35(4):e56. doi: 10.3346/jkms.2020.35.e56. No abstract available.
PMID: 31997618
citation: Huang 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. Erratum In: Lancet. 2020 Jan 30;:
PMID: 31986264
citation: Xu J, Zheng Y, Wang M, Zhao J, Zhan Q, Fu M, Wang Q, Xiao J, Cheng Y. Predictors of symptoms of posttraumatic stress in Chinese university students during the 2009 H1N1 influenza pandemic. Med Sci Monit. 2011 Jul;17(7):PH60-4. doi: 10.12659/msm.881836.
PMID: 21709644
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hend Ibrahim Shousha
investigator title: Assistant Professor
mesh term: Infections
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Problem Behavior