<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/NCT04497415</url>
  </required_header>
  <id_info>
    <org_study_id>8032</org_study_id>
    <nct_id>NCT04497415</nct_id>
  </id_info>
  <brief_title>The COVID-19 and Healthcare Workers: An Active Intervention</brief_title>
  <official_title>The COVID-19 and Healthcare Workers: An Active Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research Foundation for Mental Hygiene, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Research Foundation for Mental Hygiene, Inc.</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 overarching goal of this study is to examine the efficacy of a brief video intervention&#xD;
      in reducing stigma and fear, and improving help-seeking behavior, among health care providers&#xD;
      (N=1,200), with pre- post- and follow-up assessments (at day 14 and day 30). Participants&#xD;
      will be recruited via Amazon Turk and randomly assigned to either a) a video-based&#xD;
      intervention (day 1 and a &quot;booster intervention&quot; of the same content on day 14 of the study)&#xD;
      featuring the personal story of a health care provider during COVID-19 pandemic, his/her&#xD;
      struggles and barriers to care, (b) video-based intervention (day 1 only), and a written&#xD;
      description of the same story on day 14 (c) no-intervention control arm (questionnaires&#xD;
      only).&#xD;
&#xD;
      The invetsigators aim to (1) determine whether video-based intervention reduce stigma and&#xD;
      fear, and increase help-seeking behavior in relation to COVID-19 among health care providers,&#xD;
      and (2) compare high-risk areas (e.g., NY) to low-risk areas (e.g., Montana) on intervention&#xD;
      outcomes, and (3) test whether symptoms of depression, anxiety, PTSD and Moral Injury&#xD;
      (measured by the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7),&#xD;
      the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and the Moral Injury Events Scale (MIES))&#xD;
      would change over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world. To&#xD;
      effectively respond to the COVID-19 outbreak, various governments have implemented rapid and&#xD;
      comprehensive public health emergency interventions that include social restrictions and&#xD;
      quarantines, which is the separation and restriction of movement of people who might have&#xD;
      been exposed to the virus. While the physical risk (e.g. pneumonia, respiratory breakdown) is&#xD;
      getting the most scientific and clinical attention, this outbreak also has significant mental&#xD;
      health risks and extreme psychological fear-related responses. Psychological responses to&#xD;
      previous large-scale outbreaks, particularly to the Ebola Virus Disease (EVD) epidemic during&#xD;
      2014-2016, provide insight into the potential impact of rapidly spreading diseases on mental&#xD;
      health problems. During the Ebola outbreak, fear-related behaviors such as stigmatizing&#xD;
      infected survivors and ignoring medical procedures impeded public health efforts and&#xD;
      negatively affected the recovery of survivors. Anxiety, posttraumatic stress disorder (PTSD),&#xD;
      and depression were found in nearly half of the EVD survivors and their contacts.&#xD;
&#xD;
      The COVID-19 outbreak exceeds the scope and magnitude of most previous disasters over the&#xD;
      last 100 years. It entails a blend of risk factors for both acute and long-term mental health&#xD;
      problems. Data that is started to emerge from the COVID-19 outbreak, suggest that front lines&#xD;
      health workers (doctors; nurses) are particularly at risk. A recent study in 1257 health care&#xD;
      workers from 34 hospitals, conducted between January 29 to February 3, 2020, revealed that&#xD;
      more than half (50.4%) of the health workers were screened positive for depression, 44.6% for&#xD;
      anxiety, and 34.0% for insomnia. Consistent with previous disaster studies a dose-response&#xD;
      relationship was found between the level of exposure and outcomes. Others may develop a moral&#xD;
      injury, profound psychological distress which results in actions, or the lack of them, which&#xD;
      violet one's moral or ethical code. Given the magnitude of the COVID-19 outbreak, its risk to&#xD;
      physical and mental health, an effective and timely response is essential to address the&#xD;
      psychosocial needs associated with the ongoing exposure to disease, death, and distress among&#xD;
      health care providers, across low and high risks areas.&#xD;
&#xD;
      Many health care providers reluctant to seek support from friends and family, as well as&#xD;
      mental health care due to stigma and fear (e.g., &quot;it would be too embarrassing&quot;, &quot;I would be&#xD;
      seen as week&quot;). Despite enduring symptoms, they may wait months to years before they seek&#xD;
      help. Among reasons to avoid seeking mental health care, individuals report mistrust in&#xD;
      mental health providers, being seen as weak or stereotyped as &quot;crazy&quot;, and a belief that they&#xD;
      may be responsible for having mental health problems. Applying strategies to reduce stigma&#xD;
      and fear towards mental health care and improve help-seeking behavior may ameliorate impaired&#xD;
      functioning and reduce risks for long-term psychiatric illness.&#xD;
&#xD;
      Previous studies have shown that social contact is the most effective type of intervention to&#xD;
      reduce stigma- related attitudes and to improve help-seeking behavior. Social contact&#xD;
      involves interpersonal contact with members of the stigmatized group: members of the general&#xD;
      public who meet and interact with individuals who suffer from stress, fear, depression, or&#xD;
      anxiety and seek mental health care, are likely to lessen their stigma. Corrigan has&#xD;
      identified the most important ingredients of contact-based programs: an empowered presenter&#xD;
      with lived experience who attains his/her goals (e.g., &quot;I was able to fight the&#xD;
      depression/distress that I had following the COVID-19&quot;). While both direct, in-person social&#xD;
      contact and indirect, video-based social contact have effectively improved attitudes toward&#xD;
      mental issues and care, the latter can be implemented on a larger scale, use a minimal&#xD;
      resource and easily disseminated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 21, 2020</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Help-seeking Behavior</measure>
    <time_frame>Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)</time_frame>
    <description>Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>Assessed at baseline, 14-day follow-up, and 30-day follow-up</time_frame>
    <description>Measured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Assessed at baseline, 14-day follow-up, and 30-day follow-up</time_frame>
    <description>Measured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen</measure>
    <time_frame>Assessed at baseline, 14-day follow-up, and 30-day follow-up</time_frame>
    <description>Measured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Moral Injury Events Scale (MIES)</measure>
    <time_frame>Assessed at baseline, 14-day follow-up, and 30-day follow-up</time_frame>
    <description>Measured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Brief Video-based Intervention</condition>
  <condition>Non Intervention Control</condition>
  <arm_group>
    <arm_group_label>Video-based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A brief video about coping with COVID-19 stress presented to the participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video-Based intervention</intervention_name>
    <description>Three minutes video of a nurse that shares her personal story</description>
    <arm_group_label>Video-based intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        English speakers Healthcare workers aged 18-80 and residents of the USA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Non-English speakers, non-healthcare workers, age less than 18 or more than 80, non-US&#xD;
        residents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuval Neria, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University and NYSPI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <results_first_submitted>December 24, 2021</results_first_submitted>
  <results_first_submitted_qc>December 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2022</results_first_posted>
  <last_update_submitted>January 12, 2022</last_update_submitted>
  <last_update_submitted_qc>January 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Research Foundation for Mental Hygiene, Inc.</investigator_affiliation>
    <investigator_full_name>Yuval Y Neria</investigator_full_name>
    <investigator_title>Professor of medical psychology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT04497415/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Video-based Intervention</title>
          <description>A brief video about coping with COVID-19 stress presented to the participants&#xD;
Video-Based intervention: Three minutes video of a nurse that shares her personal story</description>
        </group>
        <group group_id="P2">
          <title>Assessment Only</title>
          <description>Control</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="229"/>
                <participants group_id="P2" count="121"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Post-intervention Assessment (Day 1)</title>
              <participants_list>
                <participants group_id="P1" count="229"/>
                <participants group_id="P2" count="121"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>First Follow-up Assessment (Day 14)</title>
              <participants_list>
                <participants group_id="P1" count="195"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="186"/>
                <participants group_id="P2" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Video-based Intervention</title>
          <description>A brief video about coping with COVID-19 stress presented to the participants&#xD;
Video-Based intervention: Three minutes video of a nurse that shares her personal story</description>
        </group>
        <group group_id="B2">
          <title>Assessment Only</title>
          <description>Control</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="229"/>
            <count group_id="B2" value="121"/>
            <count group_id="B3" value="350"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.3" spread="11.5"/>
                    <measurement group_id="B2" value="33.8" spread="11.5"/>
                    <measurement group_id="B3" value="34.8" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="260"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="201"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="316"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="256"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="229"/>
                    <measurement group_id="B2" value="121"/>
                    <measurement group_id="B3" value="350"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Occupation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Nurse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="156"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="237"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Physician</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>EMT</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Exposure to COVID-19</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Help-seeking Behavior</title>
        <description>Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions</description>
        <time_frame>Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)</time_frame>
        <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based Intervention</title>
            <description>A brief video about coping with COVID-19 stress presented to the participants&#xD;
Video-Based intervention: Three minutes video of a nurse that shares her personal story</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only</title>
            <description>Control</description>
          </group>
        </group_list>
        <measure>
          <title>Help-seeking Behavior</title>
          <description>Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions</description>
          <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" lower_limit="7.9" upper_limit="8.5"/>
                    <measurement group_id="O2" value="8.5" lower_limit="8.1" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" lower_limit="9.0" upper_limit="9.6"/>
                    <measurement group_id="O2" value="8.7" lower_limit="8.2" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>First follow-up (day 14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" lower_limit="9.4" upper_limit="10.0"/>
                    <measurement group_id="O2" value="9.3" lower_limit="8.9" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second follow-up (day 30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" lower_limit="9.1" upper_limit="9.7"/>
                    <measurement group_id="O2" value="9.1" lower_limit="8.8" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Generalized Anxiety Disorder-7 (GAD-7)</title>
        <description>Measured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety</description>
        <time_frame>Assessed at baseline, 14-day follow-up, and 30-day follow-up</time_frame>
        <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based Intervention</title>
            <description>A brief video about coping with COVID-19 stress presented to the participants&#xD;
Video-Based intervention: Three minutes video of a nurse that shares her personal story</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only</title>
            <description>Control</description>
          </group>
        </group_list>
        <measure>
          <title>Generalized Anxiety Disorder-7 (GAD-7)</title>
          <description>Measured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety</description>
          <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="5.9"/>
                    <measurement group_id="O2" value="6.7" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>First follow-up (day 14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="6.0"/>
                    <measurement group_id="O2" value="5.9" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second follow-up (day 30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="5.7"/>
                    <measurement group_id="O2" value="5.4" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Health Questionnaire-9 (PHQ-9)</title>
        <description>Measured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression</description>
        <time_frame>Assessed at baseline, 14-day follow-up, and 30-day follow-up</time_frame>
        <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based Intervention</title>
            <description>A brief video about coping with COVID-19 stress presented to the participants&#xD;
Video-Based intervention: Three minutes video of a nurse that shares her personal story</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only</title>
            <description>Control</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire-9 (PHQ-9)</title>
          <description>Measured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression</description>
          <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="6.6"/>
                    <measurement group_id="O2" value="6.6" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>First follow-up (day 14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="6.7"/>
                    <measurement group_id="O2" value="6.0" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second follow-up (day 30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="6.2"/>
                    <measurement group_id="O2" value="5.4" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen</title>
        <description>Measured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms</description>
        <time_frame>Assessed at baseline, 14-day follow-up, and 30-day follow-up</time_frame>
        <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based Intervention</title>
            <description>A brief video about coping with COVID-19 stress presented to the participants&#xD;
Video-Based intervention: Three minutes video of a nurse that shares her personal story</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only</title>
            <description>Control</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen</title>
          <description>Measured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms</description>
          <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.6"/>
                    <measurement group_id="O2" value="1.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>First follow-up (day 14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.6"/>
                    <measurement group_id="O2" value="1.2" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second follow-up (day 30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.7"/>
                    <measurement group_id="O2" value="1.4" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Moral Injury Events Scale (MIES)</title>
        <description>Measured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury</description>
        <time_frame>Assessed at baseline, 14-day follow-up, and 30-day follow-up</time_frame>
        <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based Intervention</title>
            <description>A brief video about coping with COVID-19 stress presented to the participants&#xD;
Video-Based intervention: Three minutes video of a nurse that shares her personal story</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only</title>
            <description>Control</description>
          </group>
        </group_list>
        <measure>
          <title>Moral Injury Events Scale (MIES)</title>
          <description>Measured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury</description>
          <population>Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="6.4"/>
                    <measurement group_id="O2" value="17.1" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>First follow-up (day 14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="6.8"/>
                    <measurement group_id="O2" value="16.5" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second follow-up (day 30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" spread="6.7"/>
                    <measurement group_id="O2" value="16.5" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <desc>Our definition of adverse event and serious adverse event does not differ from the clinicaltrials.gov definition.</desc>
      <group_list>
        <group group_id="E1">
          <title>Video-based Intervention</title>
          <description>A brief video about coping with COVID-19 stress presented to the participants&#xD;
Video-Based intervention: Three minutes video of a nurse that shares her personal story</description>
        </group>
        <group group_id="E2">
          <title>Assessment Only</title>
          <description>Control</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Yuval Y. Neria</name_or_title>
      <organization>New York State Psychiatric Institute</organization>
      <phone>646-774-8092</phone>
      <email>ny126@cumc.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04497415
org study id: 8032
nct id: NCT04497415
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overarching goal of this study is to examine the efficacy of a brief video intervention
      in reducing stigma and fear, and improving help-seeking behavior, among health care providers
      (N=1,200), with pre- post- and follow-up assessments (at day 14 and day 30). Participants
      will be recruited via Amazon Turk and randomly assigned to either a) a video-based
      intervention (day 1 and a "booster intervention" of the same content on day 14 of the study)
      featuring the personal story of a health care provider during COVID-19 pandemic, his/her
      struggles and barriers to care, (b) video-based intervention (day 1 only), and a written
      description of the same story on day 14 (c) no-intervention control arm (questionnaires
      only).

      The invetsigators aim to (1) determine whether video-based intervention reduce stigma and
      fear, and increase help-seeking behavior in relation to COVID-19 among health care providers,
      and (2) compare high-risk areas (e.g., NY) to low-risk areas (e.g., Montana) on intervention
      outcomes, and (3) test whether symptoms of depression, anxiety, PTSD and Moral Injury
      (measured by the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7),
      the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and the Moral Injury Events Scale (MIES))
      would change over time.
Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world. To
      effectively respond to the COVID-19 outbreak, various governments have implemented rapid and
      comprehensive public health emergency interventions that include social restrictions and
      quarantines, which is the separation and restriction of movement of people who might have
      been exposed to the virus. While the physical risk (e.g. pneumonia, respiratory breakdown) is
      getting the most scientific and clinical attention, this outbreak also has significant mental
      health risks and extreme psychological fear-related responses. Psychological responses to
      previous large-scale outbreaks, particularly to the Ebola Virus Disease (EVD) epidemic during
      2014-2016, provide insight into the potential impact of rapidly spreading diseases on mental
      health problems. During the Ebola outbreak, fear-related behaviors such as stigmatizing
      infected survivors and ignoring medical procedures impeded public health efforts and
      negatively affected the recovery of survivors. Anxiety, posttraumatic stress disorder (PTSD),
      and depression were found in nearly half of the EVD survivors and their contacts.

      The COVID-19 outbreak exceeds the scope and magnitude of most previous disasters over the
      last 100 years. It entails a blend of risk factors for both acute and long-term mental health
      problems. Data that is started to emerge from the COVID-19 outbreak, suggest that front lines
      health workers (doctors; nurses) are particularly at risk. A recent study in 1257 health care
      workers from 34 hospitals, conducted between January 29 to February 3, 2020, revealed that
      more than half (50.4%) of the health workers were screened positive for depression, 44.6% for
      anxiety, and 34.0% for insomnia. Consistent with previous disaster studies a dose-response
      relationship was found between the level of exposure and outcomes. Others may develop a moral
      injury, profound psychological distress which results in actions, or the lack of them, which
      violet one's moral or ethical code. Given the magnitude of the COVID-19 outbreak, its risk to
      physical and mental health, an effective and timely response is essential to address the
      psychosocial needs associated with the ongoing exposure to disease, death, and distress among
      health care providers, across low and high risks areas.

      Many health care providers reluctant to seek support from friends and family, as well as
      mental health care due to stigma and fear (e.g., "it would be too embarrassing", "I would be
      seen as week"). Despite enduring symptoms, they may wait months to years before they seek
      help. Among reasons to avoid seeking mental health care, individuals report mistrust in
      mental health providers, being seen as weak or stereotyped as "crazy", and a belief that they
      may be responsible for having mental health problems. Applying strategies to reduce stigma
      and fear towards mental health care and improve help-seeking behavior may ameliorate impaired
      functioning and reduce risks for long-term psychiatric illness.

      Previous studies have shown that social contact is the most effective type of intervention to
      reduce stigma- related attitudes and to improve help-seeking behavior. Social contact
      involves interpersonal contact with members of the stigmatized group: members of the general
      public who meet and interact with individuals who suffer from stress, fear, depression, or
      anxiety and seek mental health care, are likely to lessen their stigma. Corrigan has
      identified the most important ingredients of contact-based programs: an empowered presenter
      with lived experience who attains his/her goals (e.g., "I was able to fight the
      depression/distress that I had following the COVID-19"). While both direct, in-person social
      contact and indirect, video-based social contact have effectively improved attitudes toward
      mental issues and care, the latter can be implemented on a larger scale, use a minimal
      resource and easily disseminated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Help-seeking Behavior
time frame: Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)
description: Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions
measure: Generalized Anxiety Disorder-7 (GAD-7)
time frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up
description: Measured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up
description: Measured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression
measure: Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen
time frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up
description: Measured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms
measure: Moral Injury Events Scale (MIES)
time frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up
description: Measured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury
arm group label: Video-based intervention
arm group type: Experimental
description: A brief video about coping with COVID-19 stress presented to the participants
arm group label: Assessment only
arm group type: No Intervention
description: Control
intervention type: Other
intervention name: Video-Based intervention
description: Three minutes video of a nurse that shares her personal story
arm group label: Video-based intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yuval Neria, PhD
role: Principal Investigator
affiliation: Columbia University and NYSPI
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Research Foundation for Mental Hygiene, Inc.
investigator full name: Yuval Y Neria
investigator title: Professor of medical psychology
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 