<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/NCT04410835</url>
  </required_header>
  <id_info>
    <org_study_id>32-363 ex 19/20</org_study_id>
    <nct_id>NCT04410835</nct_id>
  </id_info>
  <brief_title>Psychological Impact of the Corona Virus (SARS-CoV-2) and COVID-19 Pandemic in Individuals With Psychiatric Disorders</brief_title>
  <official_title>Psychological Impact and Effect of the Corona Virus (SARS-CoV-2) and COVID-19 Pandemic in Individuals With Psychiatric Disorders - an Online Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <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 this study is to measure current affective symptoms and psychological distress in&#xD;
      individuals with severe mental illness during the COVID-19 pandemic using an online&#xD;
      questionnaire survey. In addition, this study aims at identifying individual beliefs, sleep&#xD;
      quality, attitudes concerning the virus, the adherence to the measures, believing processes,&#xD;
      and coping strategies/resilience patterns referring to COVID-19 in different study centers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A novel corona virus (SARS-CoV-2) has been identified as the cause of an outbreak of&#xD;
      respiratory illness (corona virus disease COVID-19) all over the world. The COVID-19 pandemic&#xD;
      is a public health emergency of international concern and poses a challenge to psychological&#xD;
      resilience.&#xD;
&#xD;
      Studies reviewed the psychological impact of quarantine and reported negative psychological&#xD;
      effects including post-traumatic stress symptoms, confusion, and anger, infection fears,&#xD;
      frustration, boredom, inadequate supplies, inadequate information, financial loss, and&#xD;
      stigma. A loss of daily structure and reduced social contacts were associated with&#xD;
      frustration, boredom, reduced psychological-well being and psychological distress.&#xD;
&#xD;
      A recently conducted online questionnaire survey, investigating emotional responses and&#xD;
      coping strategies of nurses, found sex differences in anxiety and fear referred to COVID-19&#xD;
      (women showed more severe anxiety and fear than men) and differences between participants&#xD;
      from cities showing more anxiety and fear compared with participants from rural showing more&#xD;
      sadness. The closer COVID-19 was to the participants, the stronger the anxiety and anger.&#xD;
&#xD;
      All these investigated psychological variables (i.e. anxiety, depression, boredom, loss of&#xD;
      daily structure) have been found to impact the course and outcome of psychiatric disorders.&#xD;
      Nowadays, COVID-19 is a pressure source with great influence, both for individuals and for&#xD;
      the social public groups. Different individuals and groups may experience different levels of&#xD;
      psychological crisis and patients with psychiatric disorders may experience more or less&#xD;
      psychological symptoms than healthy control persons. According to a recent study, lithium,&#xD;
      widely used to treat bipolar disorder, has been shown to exhibit antiviral activity and&#xD;
      appears as a possible candidate for therapy of COVID-19. However, more research data are&#xD;
      needed to develop evidence-driven strategies to reduce adverse psychological impacts and&#xD;
      psychiatric symptoms during the pandemic.&#xD;
&#xD;
      Scientific questions&#xD;
&#xD;
        1. How do psychiatric patients experience the COVID-19 outbreak including quarantine and&#xD;
           are there associations with affective symptoms and psychological distress? Is there a&#xD;
           change in symptomatology during time? Are there differences to healthy controls, and&#xD;
           between individuals with different diagnosis?&#xD;
&#xD;
        2. Is there a difference between psychiatric patients and healthy controls in regard to&#xD;
           emotional response, cognition and behaviour during the COVID-19 pandemic and quarantine?&#xD;
           Is there a difference between different psychiatric diagnosis groups?&#xD;
&#xD;
        3. Is there an association between consequences of social distance on lifestyle factors&#xD;
           (nutrition, sleep quality, physical activity, substance abuse) and are there&#xD;
           associations with psychological well-being/psychological symptoms in individuals with&#xD;
           psychiatric disorder and controls? Is there a difference between different psychiatric&#xD;
           diagnosis groups and healthy controls?&#xD;
&#xD;
        4. What do individuals with psychiatric disorders think about the COVID-19 related measures&#xD;
           und quarantine regulations and how is the adherence to the measures? Are there&#xD;
           associations between adherence and attitude towards COVID-19 measures? Is there a&#xD;
           difference between patients and healthy controls? Is there a difference between&#xD;
           different psychiatric diagnosis groups?&#xD;
&#xD;
        5. Are there sex and age differences in the investigated variables? (emotional response to&#xD;
           COVID-19 outbreak, attitude towards measures, adherence)?&#xD;
&#xD;
        6. Is there a relationship between an infection with SARS-CoV-2 and disease course in&#xD;
           psychiatric disorder? Is there a difference between different psychiatric diagnosis&#xD;
           groups and healthy controls? Which role plays lithium treatment (prescribed beyond the&#xD;
           study) in this context? The investigators hypothesize, loss of daily structure, reduced&#xD;
           social contacts, loneliness, reduced psychiatric care, and other possible lifestyle&#xD;
           changes due to the quarantine and social distancing measures, have a negative effect on&#xD;
           psychological symptoms (depression, anxiety, somatisation, sleep quality) in individuals&#xD;
           with psychiatric disorder compared to healthy controls. In contrast, resilience and&#xD;
           positive cognition processes might be positively correlated to psychological well-being.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 28, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Global symptom load (Anxiety, Somatisation, Depression, Global Symptom Index)</measure>
    <time_frame>1 year</time_frame>
    <description>Brief Symptom Inventory-18 with higher scores meaning a worse outcome (more depression, anxiety and somatization); Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 72)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>1 year</time_frame>
    <description>Beck Depression Inventory-II with higher scores mean a worse Outcome (more depressive Symptoms; each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep disorders and Sleep Quality</measure>
    <time_frame>1 year</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI) with higher scores mean a worse Outcome (more sleeping disturbances; Each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Life style changes</measure>
    <time_frame>1 year</time_frame>
    <description>Lifestyle Questions including physical activity, eating behavior, substance use, smoking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Craving</measure>
    <time_frame>1 year</time_frame>
    <description>Food Craving Inventory (FCI) with higher scores mean a worse Outcome (more Food craving; Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 112)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 associated fears and emotional responses to the pandemic</measure>
    <time_frame>1 year</time_frame>
    <description>COVID-19 questionnaire with higher scores meaning a worse Outcome (more fears and negative emotions; each item is weighted on a 0-10 interval scale)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Corona Virus Infection</condition>
  <condition>Psychiatric Disorder</condition>
  <condition>Psychological Distress</condition>
  <arm_group>
    <arm_group_label>Psychiatric patients</arm_group_label>
    <description>Psychiatric patients with ICD-10 (International Statistical Classification of Diseases and Related Health Problems) F2/F3/F4 diagnosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Participants who do not have a psychiatric disorder or a first degree relative with psychiatric disorder.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Online Survey</intervention_name>
    <description>Psychological questionnaires</description>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>Psychiatric patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Based on previous experience of the researchers working within the sector, we anticipated&#xD;
        that it would be possible to recruit a conservative average of 100 psychiatric patients per&#xD;
        outpatient clinic Thus, we aim to recruit at least 500 patients and 500 healthy controls in&#xD;
        total which would be a large enough sample to conduct most subgroup analyses. Nevertheless,&#xD;
        in case we can recruit a larger number of participants allowing further subgroup analysis&#xD;
        it would be useful. The assumed response rate is 70 %.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age 18 years&#xD;
&#xD;
          -  voluntary participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject refuses to participate&#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>Eva Reininghaus, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eva Reininghaus, Prof.</last_name>
    <phone>004331638580968</phone>
    <email>eva.reininghaus@medunigraz.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nina Dalkner, PD Dr.</last_name>
    <phone>004331638530081</phone>
    <email>nina.dalkner@medunigraz.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University Graz, Department of Psychiatry and Psychotherapeutic Medicine</name>
      <address>
        <city>Graz</city>
        <state>Styria</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eva Reininghaus, Asszo.Prof.</last_name>
      <phone>+43316-385-80968</phone>
      <email>eva.reininghaus@medunigraz.at</email>
    </contact>
    <contact_backup>
      <last_name>Nina Dalkner, PD Dr.</last_name>
      <phone>+43316-385-30081</phone>
      <phone_ext>06603497536</phone_ext>
      <email>nina.dalkner@medunigraz.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>July 23, 2021</last_update_submitted>
  <last_update_submitted_qc>July 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2021</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>Coronavirus Infections</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04410835
org study id: 32-363 ex 19/20
nct id: NCT04410835
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to measure current affective symptoms and psychological distress in
      individuals with severe mental illness during the COVID-19 pandemic using an online
      questionnaire survey. In addition, this study aims at identifying individual beliefs, sleep
      quality, attitudes concerning the virus, the adherence to the measures, believing processes,
      and coping strategies/resilience patterns referring to COVID-19 in different study centers.
A novel corona virus (SARS-CoV-2) has been identified as the cause of an outbreak of
      respiratory illness (corona virus disease COVID-19) all over the world. The COVID-19 pandemic
      is a public health emergency of international concern and poses a challenge to psychological
      resilience.

      Studies reviewed the psychological impact of quarantine and reported negative psychological
      effects including post-traumatic stress symptoms, confusion, and anger, infection fears,
      frustration, boredom, inadequate supplies, inadequate information, financial loss, and
      stigma. A loss of daily structure and reduced social contacts were associated with
      frustration, boredom, reduced psychological-well being and psychological distress.

      A recently conducted online questionnaire survey, investigating emotional responses and
      coping strategies of nurses, found sex differences in anxiety and fear referred to COVID-19
      (women showed more severe anxiety and fear than men) and differences between participants
      from cities showing more anxiety and fear compared with participants from rural showing more
      sadness. The closer COVID-19 was to the participants, the stronger the anxiety and anger.

      All these investigated psychological variables (i.e. anxiety, depression, boredom, loss of
      daily structure) have been found to impact the course and outcome of psychiatric disorders.
      Nowadays, COVID-19 is a pressure source with great influence, both for individuals and for
      the social public groups. Different individuals and groups may experience different levels of
      psychological crisis and patients with psychiatric disorders may experience more or less
      psychological symptoms than healthy control persons. According to a recent study, lithium,
      widely used to treat bipolar disorder, has been shown to exhibit antiviral activity and
      appears as a possible candidate for therapy of COVID-19. However, more research data are
      needed to develop evidence-driven strategies to reduce adverse psychological impacts and
      psychiatric symptoms during the pandemic.

      Scientific questions

        1. How do psychiatric patients experience the COVID-19 outbreak including quarantine and
           are there associations with affective symptoms and psychological distress? Is there a
           change in symptomatology during time? Are there differences to healthy controls, and
           between individuals with different diagnosis?

        2. Is there a difference between psychiatric patients and healthy controls in regard to
           emotional response, cognition and behaviour during the COVID-19 pandemic and quarantine?
           Is there a difference between different psychiatric diagnosis groups?

        3. Is there an association between consequences of social distance on lifestyle factors
           (nutrition, sleep quality, physical activity, substance abuse) and are there
           associations with psychological well-being/psychological symptoms in individuals with
           psychiatric disorder and controls? Is there a difference between different psychiatric
           diagnosis groups and healthy controls?

        4. What do individuals with psychiatric disorders think about the COVID-19 related measures
           und quarantine regulations and how is the adherence to the measures? Are there
           associations between adherence and attitude towards COVID-19 measures? Is there a
           difference between patients and healthy controls? Is there a difference between
           different psychiatric diagnosis groups?

        5. Are there sex and age differences in the investigated variables? (emotional response to
           COVID-19 outbreak, attitude towards measures, adherence)?

        6. Is there a relationship between an infection with SARS-CoV-2 and disease course in
           psychiatric disorder? Is there a difference between different psychiatric diagnosis
           groups and healthy controls? Which role plays lithium treatment (prescribed beyond the
           study) in this context? The investigators hypothesize, loss of daily structure, reduced
           social contacts, loneliness, reduced psychiatric care, and other possible lifestyle
           changes due to the quarantine and social distancing measures, have a negative effect on
           psychological symptoms (depression, anxiety, somatisation, sleep quality) in individuals
           with psychiatric disorder compared to healthy controls. In contrast, resilience and
           positive cognition processes might be positively correlated to psychological well-being.
observational model: Cohort
time perspective: Prospective
measure: Global symptom load (Anxiety, Somatisation, Depression, Global Symptom Index)
time frame: 1 year
description: Brief Symptom Inventory-18 with higher scores meaning a worse outcome (more depression, anxiety and somatization); Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 72)
measure: Depressive symptoms
time frame: 1 year
description: Beck Depression Inventory-II with higher scores mean a worse Outcome (more depressive Symptoms; each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)
measure: Sleep disorders and Sleep Quality
time frame: 1 year
description: Pittsburgh Sleep Quality Index (PSQI) with higher scores mean a worse Outcome (more sleeping disturbances; Each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)
measure: Life style changes
time frame: 1 year
description: Lifestyle Questions including physical activity, eating behavior, substance use, smoking
measure: Food Craving
time frame: 1 year
description: Food Craving Inventory (FCI) with higher scores mean a worse Outcome (more Food craving; Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 112)
measure: COVID-19 associated fears and emotional responses to the pandemic
time frame: 1 year
description: COVID-19 questionnaire with higher scores meaning a worse Outcome (more fears and negative emotions; each item is weighted on a 0-10 interval scale)
arm group label: Psychiatric patients
description: Psychiatric patients with ICD-10 (International Statistical Classification of Diseases and Related Health Problems) F2/F3/F4 diagnosis
arm group label: Healthy Controls
description: Participants who do not have a psychiatric disorder or a first degree relative with psychiatric disorder.
intervention type: Diagnostic Test
intervention name: Online Survey
description: Psychological questionnaires
arm group label: Healthy Controls
arm group label: Psychiatric patients
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: Eva Reininghaus, Prof.
role: Principal Investigator
affiliation: Medical University of Graz
last name: Eva Reininghaus, Prof.
phone: 004331638580968
email: eva.reininghaus@medunigraz.at
last name: Nina Dalkner, PD Dr.
phone: 004331638530081
email: nina.dalkner@medunigraz.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Mental Disorders
mesh term: Problem Behavior
sharing ipd: Undecided