<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/NCT04484207</url>
  </required_header>
  <id_info>
    <org_study_id>8006</org_study_id>
    <nct_id>NCT04484207</nct_id>
  </id_info>
  <brief_title>Addressing COVID-19 Mental Health Problems Among US Veterans</brief_title>
  <official_title>Addressing COVID-19 Mental Health Problems Among US Veterans</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>
      Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world,&#xD;
      overwhelming intensive care units and health care capacity. While the physical risk (e.g.&#xD;
      pneumonia, respiratory breakdown) is getting the most scientific and clinical attention, this&#xD;
      outbreak also has significant mental health risks and extreme psychological fear-related&#xD;
      responses. Among the general population, there are high-risk groups as elderly people,&#xD;
      disabled individuals and people with previous exposure to trauma (e.g., people with military&#xD;
      experience). Veterans are among the subgroups who are high risk for PTSD and other mental&#xD;
      health problem. The overarching goal of this study is to examine the efficacy of an online,&#xD;
      largescale, brief video-based intervention in reducing fear and stress and improving help&#xD;
      seeking behavior in relate to COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world,&#xD;
      overwhelming intensive care units and health care capacity, leading the World Health&#xD;
      Organization (WHO) to declare a pandemic. According to the official website of the WHO1, more&#xD;
      than 3 million people have been confirmed to have a COVID-19 infection, and over than 200,000&#xD;
      deaths have resulted from COVID-19 in almost every area or territories around the world. To&#xD;
      effectively cope with 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. Non-essential workers were required to stay at home and the&#xD;
      shutdown of non-essential businesses are among the restrictions that influence the lives of&#xD;
      millions across the globe. 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.&#xD;
&#xD;
      The outbreak of COVID-19 caused public panic and mental health stress. The rapidly changing&#xD;
      information on COVID-19 and the increasing number of confirmed cases and death have elicited&#xD;
      fear and anxiety about becoming infected. Isolated at home, people consume information that&#xD;
      might be unreliable and unverified for many hours every day. The widespread use of social&#xD;
      media and the extensive array (or sources) of information can increase confusion and worries&#xD;
      which in turn increases fear and anxiety. Moreover, indirect exposure to 24-hours of&#xD;
      television news and social media has a wide range of psychopathological consequences, of&#xD;
      which Posttraumatic Stress Disorder (PTSD) symptoms are the most common. A recent study&#xD;
      conducted in China one month into the outbreak examined the prevalence of mental health&#xD;
      problems in COVID-19 era and found a high rate of depression (48.3%), anxiety (22.6%) and a&#xD;
      combination of depression and anxiety (19.4%) among 4,872 people. Furthermore, people with&#xD;
      increased social media exposure were almost twice as likely to have depression and anxiety&#xD;
      than people with less social media exposure. To date, more than 3 billion people are being&#xD;
      asked to stay at home, which may lead to increased exposure to social media, likely resulting&#xD;
      in widespread mental health problems among isolated individuals around the globe. Given the&#xD;
      magnitude of the COVID-19 outbreak, its risk to physical and mental health,and the unique&#xD;
      nature requiring to stay isolated, sheltered, at hospitals, or at home, an effective and&#xD;
      timely response is essential to address the psychosocial needs associated with the ongoing&#xD;
      exposure to social media, disease, death, and distress.&#xD;
&#xD;
      Among the general population, there are high-risk groups as elderly people, disabled&#xD;
      individuals and people with previous exposure to trauma (e.g., people with military&#xD;
      experience). Veterans are among the subgroups who are high risk for PTSD and other mental&#xD;
      health problem. Furthermore, many veterans are reluctant to seek help, despite enduring&#xD;
      symptoms, they avoid mental health care, or may wait years to decades before they seek help.&#xD;
      Among reasons to avoid seeking help, patients report mistrust in mental health providers,&#xD;
      being seen as weak or stereotyped as &quot;dangerous/violent/crazy&quot;, and a belief that they are&#xD;
      responsible for having mental health problems. Applying strategies to reduce self-stigma and&#xD;
      improve help seeking behavior among veterans may ameliorate impaired functioning and reduce&#xD;
      risks for long-term psychiatric illness. Thornicroft showed that social contact is the most&#xD;
      effective type of intervention to improve helpseeking behavior and stigma-related attitudes.&#xD;
      Social contact involves interpersonal contact with a member of the group; While both direct,&#xD;
      in-person social contact and indirect, video-based social contact have effectively improved&#xD;
      attitudes toward mental illness, the latter can be implemented on a larger scale. Corrigan&#xD;
      and colleagues11 identified the most important ingredients of contact-based programs: an&#xD;
      empowered presenter with lived experience who attains his/her goals (e.g., &quot;I was able to&#xD;
      fight the COVID-19&quot;).&#xD;
&#xD;
      The overarching goal of this study is to examine the efficacy of an online, large-scale,&#xD;
      brief video-based intervention in reducing fear and stress and improving help seeking&#xD;
      behavior in relate to COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Actual">October 26, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 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 Intention</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>Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD</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>Attitudes Toward Seeking Professional Help Scale among veterans who reported anxiety, depression, or PTSD Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>Brief Video-based Intervention</condition>
  <condition>Vignette Based Intervention</condition>
  <condition>Non Intervention Control Arm</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>vignette intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A brief vignette about coping with COVID-19 stress presented to the participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only assessment, no intervention arrm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A short video intervention</intervention_name>
    <description>Three minutes video of a veteran that shares his personal story</description>
    <arm_group_label>Video-based intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A vignette intervention</intervention_name>
    <description>A written description of the content of the video</description>
    <arm_group_label>vignette intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speakers, veterans (military experience) aged 18-80, US residents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-English speakers, age less than 18 or more than 80&#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 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>October 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <results_first_submitted>October 12, 2021</results_first_submitted>
  <results_first_submitted_qc>October 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2021</results_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</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>Yes</sharing_ipd>
    <ipd_description>Data will be shared as needed with investigators, IRB etc. A plan will be determined in the short future</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>two months</ipd_time_frame>
    <ipd_access_criteria>Co-Is</ipd_access_criteria>
  </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 6, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT04484207/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>First, we excluded duplicate submissions, assessments completed in less than minimum expected time, locations (coordinates) outside of the United States, and suspicious IP addresses. Second, we used an open-ended question format requiring the participant's age as a validity question and allowed only a two-digit number as a valid answer and compared responses with age data MTurk provided. Third, we added a question about military trauma with an option of &quot;I did not serve in the military.&quot;</pre_assignment_details>
      <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;
A short video intervention: Three minute video of a veteran who shares his personal story</description>
        </group>
        <group group_id="P2">
          <title>Vignette Intervention</title>
          <description>A brief vignette about coping with COVID-19 stress presented to the participants&#xD;
A vignette intervention: A written description of the content of the video</description>
        </group>
        <group group_id="P3">
          <title>Control</title>
          <description>Only assessment, no intervention arrm</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>14-Day Follow-Up</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>30-Day Follow-Up</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
          </milestone_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;
A short video intervention: Three minute video of a veteran who shares his personal story</description>
        </group>
        <group group_id="B2">
          <title>Vignette Intervention</title>
          <description>A brief vignette about coping with COVID-19 stress presented to the participants&#xD;
A vignette intervention: A written description of the content of the video</description>
        </group>
        <group group_id="B3">
          <title>Control</title>
          <description>Only assessment, no intervention arrm</description>
        </group>
        <group group_id="B4">
          <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="86"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="42"/>
            <count group_id="B4" value="172"/>
          </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="48.2" spread="14.3"/>
                    <measurement group_id="B2" value="45.4" spread="13.3"/>
                    <measurement group_id="B3" value="47.3" spread="15.6"/>
                    <measurement group_id="B4" value="47.2" spread="14.3"/>
                  </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="26"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="118"/>
                  </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="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="157"/>
                  </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 group_id="B4" 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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="131"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="12"/>
                  </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="86"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Exposure to Military Trauma</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="49"/>
                  </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="26"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Help Seeking Intention</title>
        <description>Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help 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>Using the GEE method, all participants from this arm were analyzed at all time points.</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;
A short video intervention: Three minute video of a veteran who shares his personal story</description>
          </group>
          <group group_id="O2">
            <title>Vignette Intervention</title>
            <description>A brief vignette about coping with COVID-19 stress presented to the participants&#xD;
A vignette intervention: A written description of the content of the video</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Only assessment, no intervention arrm</description>
          </group>
        </group_list>
        <measure>
          <title>Help Seeking Intention</title>
          <description>Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions</description>
          <population>Using the GEE method, all participants from this arm were analyzed at all time points.</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="86"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="2.7"/>
                    <measurement group_id="O2" value="7.9" spread="2.3"/>
                    <measurement group_id="O3" value="7.3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="2.5"/>
                    <measurement group_id="O2" value="8.1" spread="2.2"/>
                    <measurement group_id="O3" value="7.6" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Day Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="1.1"/>
                    <measurement group_id="O2" value="8.7" spread="1.3"/>
                    <measurement group_id="O3" value="8.2" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-Day Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="1.2"/>
                    <measurement group_id="O2" value="8.6" spread="1.1"/>
                    <measurement group_id="O3" value="8.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.031</p_value>
            <method>GEE</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD</title>
        <description>Attitudes Toward Seeking Professional Help Scale among veterans who reported anxiety, depression, or PTSD Minimum value: 3 Maximum value: 12 Higher scores indicate higher help 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>In order to measure this outcome, only veterans from the original sample who reported symptoms of anxiety, depression, or PTSD were analyzed. Using the GEE method, all participants from this arm were analyzed at all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based Intervention</title>
            <description>A brief video about coping with COVID-19 stress presented to participants who reported anxiety, depression, or PTSD.&#xD;
A short video intervention: Three minute video of a veteran who shares his personal story</description>
          </group>
          <group group_id="O2">
            <title>Vignette Intervention</title>
            <description>A brief vignette about coping with COVID-19 stress presented to participants who reported anxiety, depression, or PTSD.&#xD;
A vignette intervention: A written description of the content of the video</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Only assessment, no intervention arm provided to participants who reported anxiety, depression, or PTSD.</description>
          </group>
        </group_list>
        <measure>
          <title>Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD</title>
          <description>Attitudes Toward Seeking Professional Help Scale among veterans who reported anxiety, depression, or PTSD Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions</description>
          <population>In order to measure this outcome, only veterans from the original sample who reported symptoms of anxiety, depression, or PTSD were analyzed. Using the GEE method, all participants from this arm were analyzed at all time points.</population>
          <units>score 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="54"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" lower_limit="6.9" upper_limit="8.3"/>
                    <measurement group_id="O2" value="8.1" lower_limit="7.4" upper_limit="8.8"/>
                    <measurement group_id="O3" value="7.7" lower_limit="6.9" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="7.9" upper_limit="9.1"/>
                    <measurement group_id="O2" value="8.1" lower_limit="7.3" upper_limit="8.9"/>
                    <measurement group_id="O3" value="8.0" lower_limit="7.3" upper_limit="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Day Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" lower_limit="8.3" upper_limit="9.6"/>
                    <measurement group_id="O2" value="8.5" lower_limit="8.1" upper_limit="9.0"/>
                    <measurement group_id="O3" value="8.2" lower_limit="7.5" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-Day Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" lower_limit="7.9" upper_limit="9.3"/>
                    <measurement group_id="O2" value="8.3" lower_limit="7.9" upper_limit="8.8"/>
                    <measurement group_id="O3" value="8.2" lower_limit="7.7" upper_limit="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over the 30 days of the study period.</time_frame>
      <desc>Our definitions of adverse event and serious adverse event do not differ from the definitions found on clinicaltrials.gov.</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;
A short video intervention: Three minute video of a veteran who shares his personal story</description>
        </group>
        <group group_id="E2">
          <title>Vignette Intervention</title>
          <description>A brief vignette about coping with COVID-19 stress presented to the participants&#xD;
A vignette intervention: A written description of the content of the video</description>
        </group>
        <group group_id="E3">
          <title>Control</title>
          <description>Only assessment, no intervention arrm</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="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
              </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="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
              </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/NCT04484207
org study id: 8006
nct id: NCT04484207
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world,
      overwhelming intensive care units and health care capacity. 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. Among the general population, there are high-risk groups as elderly people,
      disabled individuals and people with previous exposure to trauma (e.g., people with military
      experience). Veterans are among the subgroups who are high risk for PTSD and other mental
      health problem. The overarching goal of this study is to examine the efficacy of an online,
      largescale, brief video-based intervention in reducing fear and stress and improving help
      seeking behavior in relate to COVID-19.
Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world,
      overwhelming intensive care units and health care capacity, leading the World Health
      Organization (WHO) to declare a pandemic. According to the official website of the WHO1, more
      than 3 million people have been confirmed to have a COVID-19 infection, and over than 200,000
      deaths have resulted from COVID-19 in almost every area or territories around the world. To
      effectively cope with 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. Non-essential workers were required to stay at home and the
      shutdown of non-essential businesses are among the restrictions that influence the lives of
      millions across the globe. 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.

      The outbreak of COVID-19 caused public panic and mental health stress. The rapidly changing
      information on COVID-19 and the increasing number of confirmed cases and death have elicited
      fear and anxiety about becoming infected. Isolated at home, people consume information that
      might be unreliable and unverified for many hours every day. The widespread use of social
      media and the extensive array (or sources) of information can increase confusion and worries
      which in turn increases fear and anxiety. Moreover, indirect exposure to 24-hours of
      television news and social media has a wide range of psychopathological consequences, of
      which Posttraumatic Stress Disorder (PTSD) symptoms are the most common. A recent study
      conducted in China one month into the outbreak examined the prevalence of mental health
      problems in COVID-19 era and found a high rate of depression (48.3%), anxiety (22.6%) and a
      combination of depression and anxiety (19.4%) among 4,872 people. Furthermore, people with
      increased social media exposure were almost twice as likely to have depression and anxiety
      than people with less social media exposure. To date, more than 3 billion people are being
      asked to stay at home, which may lead to increased exposure to social media, likely resulting
      in widespread mental health problems among isolated individuals around the globe. Given the
      magnitude of the COVID-19 outbreak, its risk to physical and mental health,and the unique
      nature requiring to stay isolated, sheltered, at hospitals, or at home, an effective and
      timely response is essential to address the psychosocial needs associated with the ongoing
      exposure to social media, disease, death, and distress.

      Among the general population, there are high-risk groups as elderly people, disabled
      individuals and people with previous exposure to trauma (e.g., people with military
      experience). Veterans are among the subgroups who are high risk for PTSD and other mental
      health problem. Furthermore, many veterans are reluctant to seek help, despite enduring
      symptoms, they avoid mental health care, or may wait years to decades before they seek help.
      Among reasons to avoid seeking help, patients report mistrust in mental health providers,
      being seen as weak or stereotyped as "dangerous/violent/crazy", and a belief that they are
      responsible for having mental health problems. Applying strategies to reduce self-stigma and
      improve help seeking behavior among veterans may ameliorate impaired functioning and reduce
      risks for long-term psychiatric illness. Thornicroft showed that social contact is the most
      effective type of intervention to improve helpseeking behavior and stigma-related attitudes.
      Social contact involves interpersonal contact with a member of the group; While both direct,
      in-person social contact and indirect, video-based social contact have effectively improved
      attitudes toward mental illness, the latter can be implemented on a larger scale. Corrigan
      and colleagues11 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 COVID-19").

      The overarching goal of this study is to examine the efficacy of an online, large-scale,
      brief video-based intervention in reducing fear and stress and improving help seeking
      behavior in relate to COVID-19.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Help Seeking Intention
time frame: Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)
description: Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions
measure: Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD
time frame: Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)
description: Attitudes Toward Seeking Professional Help Scale among veterans who reported anxiety, depression, or PTSD Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions
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: vignette intervention
arm group type: Experimental
description: A brief vignette about coping with COVID-19 stress presented to the participants
arm group label: Control
arm group type: No Intervention
description: Only assessment, no intervention arrm
intervention type: Other
intervention name: A short video intervention
description: Three minutes video of a veteran that shares his personal story
arm group label: Video-based intervention
intervention type: Other
intervention name: A vignette intervention
description: A written description of the content of the video
arm group label: vignette intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yuval Neria 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: Yes
ipd description: Data will be shared as needed with investigators, IRB etc. A plan will be determined in the short future
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: two months
ipd access criteria: Co-Is
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 