<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/NCT04407195</url>
  </required_header>
  <id_info>
    <org_study_id>20-05-22</org_study_id>
    <nct_id>NCT04407195</nct_id>
  </id_info>
  <brief_title>COVID-19 and Mental Health</brief_title>
  <official_title>Mental Health Outcomes Among US Healthcare Workers Exposed to COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northeastern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northeastern 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 overall objective of this study is to assess the enormity of mental health outcomes among&#xD;
      healthcare providers (nurses and physicians) exposed to COVID-19 during the time of the&#xD;
      pandemic in the United States, specifically targeting those areas most effected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthcare providers (nurses and physicians) on the frontlines of the COVID-19 response are&#xD;
      facing a critical situation and are subject to increased psychological distress. Those&#xD;
      directly involved in the diagnosis, treatment and care of patients with COVID-19 are at&#xD;
      significant risk of developing physical, psychological, and psychosocial distress.&#xD;
&#xD;
      The data examined in this study will further clarify the mental distress experienced by&#xD;
      healthcare workers and lead to the development of peer-support and educational initiatives to&#xD;
      improve these findings. The central hypothesis of this research is that high levels of mental&#xD;
      distress will be associated with caring for patients with COVID-19.&#xD;
&#xD;
      This study will use an observational, cross-sectional on-line survey design. Participants&#xD;
      will complete a 15 minute self-administered questionnaire. All data will be de-identified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</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>Emotional Impact</measure>
    <time_frame>7 days</time_frame>
    <description>The Impact of Event Scale - Revised (IES-R). IES-R is a 22-item scale with possible scores ranging from 0 - 88. Scores higher than 24 are of concern indicating possible health and well-being consequences.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>2 weeks</time_frame>
    <description>Patient Health Questionaire (PHQ-9). The PHQ-9 has a range from 0 - 27. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>2 weeks</time_frame>
    <description>Generalized Anxiety Disorder 7-item (GAD-7). Scores range from 0 - 21. When screening for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>1 week</time_frame>
    <description>The ISI7 is a 7-item instrument designed to assess the nature, severity, and impact of insomnia in adults. Scores range from 0 - 28. Higher scores indicate increased likelihood of sleep disturbances.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>2 Weeks</time_frame>
    <description>Brief Resilience Scale (BRS) is a 6-item scale with scores ranging from 6-30 with higher scores indicating greater resilience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crisis Support Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>The Crisis Support Scale (CSS) is a 7-item instrument developed to measure received social support. Scores range from 7 - 98, with higher scores correlating with increased social support.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>COVID-19</condition>
  <condition>Mental Health Disorder</condition>
  <arm_group>
    <arm_group_label>Healthcare Providers</arm_group_label>
    <description>Healthcare workers (physicians and nurses) who have interacted with patients with known or suspected COVID-19.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exposure to the SARS-CoV-2</intervention_name>
    <description>This is an observational design. Participants are exposed to the Covid-19 pandemic.</description>
    <arm_group_label>Healthcare Providers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include physicians and nurse who interact with patients with known or&#xD;
        suspected COVID-19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthcare providers (physicians and nurse) working in institutions with known or&#xD;
             suspected COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nurses and physicians who are retired, or not currently employed or not working in an&#xD;
             environment with known or suspected COVID-19.&#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>
  <location>
    <facility>
      <name>Northeastern University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 2, 2021</last_update_submitted>
  <last_update_submitted_qc>September 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northeastern University</investigator_affiliation>
    <investigator_full_name>Kara Pavone</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Mental Disorders</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/NCT04407195
org study id: 20-05-22
nct id: NCT04407195
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of this study is to assess the enormity of mental health outcomes among
      healthcare providers (nurses and physicians) exposed to COVID-19 during the time of the
      pandemic in the United States, specifically targeting those areas most effected.
Healthcare providers (nurses and physicians) on the frontlines of the COVID-19 response are
      facing a critical situation and are subject to increased psychological distress. Those
      directly involved in the diagnosis, treatment and care of patients with COVID-19 are at
      significant risk of developing physical, psychological, and psychosocial distress.

      The data examined in this study will further clarify the mental distress experienced by
      healthcare workers and lead to the development of peer-support and educational initiatives to
      improve these findings. The central hypothesis of this research is that high levels of mental
      distress will be associated with caring for patients with COVID-19.

      This study will use an observational, cross-sectional on-line survey design. Participants
      will complete a 15 minute self-administered questionnaire. All data will be de-identified.
observational model: Cohort
time perspective: Prospective
measure: Emotional Impact
time frame: 7 days
description: The Impact of Event Scale - Revised (IES-R). IES-R is a 22-item scale with possible scores ranging from 0 - 88. Scores higher than 24 are of concern indicating possible health and well-being consequences.
measure: Depression
time frame: 2 weeks
description: Patient Health Questionaire (PHQ-9). The PHQ-9 has a range from 0 - 27. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.
measure: Anxiety
time frame: 2 weeks
description: Generalized Anxiety Disorder 7-item (GAD-7). Scores range from 0 - 21. When screening for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.
measure: Insomnia
time frame: 1 week
description: The ISI7 is a 7-item instrument designed to assess the nature, severity, and impact of insomnia in adults. Scores range from 0 - 28. Higher scores indicate increased likelihood of sleep disturbances.
measure: Resilience
time frame: 2 Weeks
description: Brief Resilience Scale (BRS) is a 6-item scale with scores ranging from 6-30 with higher scores indicating greater resilience.
measure: Crisis Support Scale
time frame: 2 weeks
description: The Crisis Support Scale (CSS) is a 7-item instrument developed to measure received social support. Scores range from 7 - 98, with higher scores correlating with increased social support.
arm group label: Healthcare Providers
description: Healthcare workers (physicians and nurses) who have interacted with patients with known or suspected COVID-19.
intervention type: Other
intervention name: Exposure to the SARS-CoV-2
description: This is an observational design. Participants are exposed to the Covid-19 pandemic.
arm group label: Healthcare Providers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northeastern University
investigator full name: Kara Pavone
investigator title: Assistant Professor
mesh term: COVID-19
mesh term: Mental Disorders
sharing ipd: No