xml: <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/NCT05968300</url>
    </required_header>
    <id_info>
      <org_study_id>P0567396</org_study_id>
      <nct_id>NCT05968300</nct_id>
    </id_info>
    <brief_title>Getting INFORMED and Living Well Among Asian Americans in California</brief_title>
    <official_title>Getting INFORMED and Living Well: A Demonstration Project to Facilitate Pandemic Recovery Among Asian Americans in California</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Chinese Community Health Resource Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of California, Davis</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of California, Merced</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>California Department of Public Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Francisco</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 project is to facilitate pandemic recovery by promoting emotional wellness among Asian&#xD;
        Californians. The intervention includes a 6-week program in which participants may choose to&#xD;
        receive text only or text + Lay Health Worker outreach targeting 600 self-identified Asian&#xD;
        Americans residing in California who speak/read English, Chinese, Korean, Hmong, or&#xD;
        Vietnamese.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Investigators will conduct a non-randomized intervention trial (preference trial). Research&#xD;
        participants involved in the trial will include 20 lay health workers (LHWs) and 600 trial&#xD;
        participants with intervention delivered via SMS text messaging (for all participants), and&#xD;
        the intervention group will receive educational intervention outreach from an LHW via Zoom or&#xD;
        mutually agreed video conferencing online venues, and by telephone or instant messaging.&#xD;
        Participants will choose which group they are in, SMS text messaging only or SMS text&#xD;
        messaging plus educational outreach from an LHW.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Non-randomized trial (Preference trial)</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in decisional conflict scale (SURE) scores</measure>
      <time_frame>Baseline and 8-week follow-up</time_frame>
      <description>Self-assessed perceptions of decision conflict will be assessed using the 4-item Decision Conflict Scale (SURE). Scores on the SURE scale range from 0 to 4, with higher scores indicating less decisional conflict. A score of less than 4 indicates decisional conflict.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in proportion of participants who have Intention to seek help for mental health</measure>
      <time_frame>Baseline and 8-week follow-up</time_frame>
      <description>We will use a survey item to assess participants' intention to seek help for mental health issues when needed. A response will be 0 (No) or 1 (Yes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-reported emotional wellness outcome</measure>
      <time_frame>Baseline and 8-week follow-up</time_frame>
      <description>We will use the four-item Patient Health Questionnaire (PHQ4) for measuring anxiety and depression symptoms. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score 3 or higher for the first 2 questions suggests anxiety, and total score 3 or higher for the last 2 questions suggests depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the percentage of participants' awareness of resources to get help or to learn more about improving emotional wellness</measure>
      <time_frame>Baseline and 8-week follow-up</time_frame>
      <description>We will assess participants' awareness of resources to get help or to learn more about improving emotional wellness. Two items created for the study will be used: 1) Do you know about &quot;988&quot;? (Yes, No, Unsure) 2) Do you know where to get help for mental health issues when you need to? (Yes, No, Unsure). The percentage of participants who answer &quot;yes&quot; to both questions will be assessed.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>COVID-19</condition>
    <condition>Well-Being, Psychological</condition>
    <arm_group>
      <arm_group_label>INFORMED-Living Well</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>INFORMED-Living Well consists of two components: 1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging. The LHW educational outreach component includes 2 small group educational sessions with 2-8 participants. Participants will also receive a weekly SMS Text or instant message on managing emotional wellness within and beyond the context of the COVID-19 pandemic over 6 weeks. In addition, participants will receive as-needed messages on updates of COVID-19 or other situations that may introduce new worries and tragic culturally-based traumatic events.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Text Messaging Only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will have a 6-week SMS text messaging program identical to that received by the INFORMED-Living Well participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>INFORMED-Living Well</intervention_name>
      <description>1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging</description>
      <arm_group_label>INFORMED-Living Well</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Text Messaging Only</intervention_name>
      <description>A 6-week automated SMS text messaging</description>
      <arm_group_label>Text Messaging Only</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          i) age 18 and older&#xD;
  &#xD;
          ii) speak Chinese, English, Hmong, Korean, or Vietnamese&#xD;
  &#xD;
          iii) self-identify as Asian American&#xD;
  &#xD;
          iv) have access to a mobile phone to receive SMS text messages&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unwilling to receive SMS text messages from the project&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Janice Tsoh, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>JiWon Choi, PhD</last_name>
      <phone>415-514-2534</phone>
      <email>jiwon.choi@ucsf.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Fresno Center</name>
        <address>
          <city>Fresno</city>
          <state>California</state>
          <zip>93727</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Chinese Community Health Resource Center</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94133</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joyce Cheng, MS</last_name>
        <phone>415-677-2473</phone>
        <email>joycec@chasf.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of California, San Francisco</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94143</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Immigrant Resettlement &amp; Cultural Center</name>
        <address>
          <city>San Jose</city>
          <state>California</state>
          <zip>95131</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nam Pham</last_name>
        <phone>408-452-5784</phone>
        <email>phamphunam@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Asian Americans</keyword>
    <keyword>Peer Education</keyword>
    <keyword>Immigrants</keyword>
    <keyword>Chinese</keyword>
    <keyword>Hmong</keyword>
    <keyword>Korean</keyword>
    <keyword>Vietnamese</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968300
  org study id: P0567396
  nct id: NCT05968300
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The project is to facilitate pandemic recovery by promoting emotional wellness among Asian
        Californians. The intervention includes a 6-week program in which participants may choose to
        receive text only or text + Lay Health Worker outreach targeting 600 self-identified Asian
        Americans residing in California who speak/read English, Chinese, Korean, Hmong, or
        Vietnamese.
  Investigators will conduct a non-randomized intervention trial (preference trial). Research
        participants involved in the trial will include 20 lay health workers (LHWs) and 600 trial
        participants with intervention delivered via SMS text messaging (for all participants), and
        the intervention group will receive educational intervention outreach from an LHW via Zoom or
        mutually agreed video conferencing online venues, and by telephone or instant messaging.
        Participants will choose which group they are in, SMS text messaging only or SMS text
        messaging plus educational outreach from an LHW.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Non-randomized trial (Preference trial)
  primary purpose: Other
  masking: None (Open Label)
  measure: Change in decisional conflict scale (SURE) scores
  time frame: Baseline and 8-week follow-up
  description: Self-assessed perceptions of decision conflict will be assessed using the 4-item Decision Conflict Scale (SURE). Scores on the SURE scale range from 0 to 4, with higher scores indicating less decisional conflict. A score of less than 4 indicates decisional conflict.
  measure: Change in proportion of participants who have Intention to seek help for mental health
  time frame: Baseline and 8-week follow-up
  description: We will use a survey item to assess participants' intention to seek help for mental health issues when needed. A response will be 0 (No) or 1 (Yes).
  measure: Change in self-reported emotional wellness outcome
  time frame: Baseline and 8-week follow-up
  description: We will use the four-item Patient Health Questionnaire (PHQ4) for measuring anxiety and depression symptoms. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score 3 or higher for the first 2 questions suggests anxiety, and total score 3 or higher for the last 2 questions suggests depression.
  measure: Change in the percentage of participants' awareness of resources to get help or to learn more about improving emotional wellness
  time frame: Baseline and 8-week follow-up
  description: We will assess participants' awareness of resources to get help or to learn more about improving emotional wellness. Two items created for the study will be used: 1) Do you know about "988"? (Yes, No, Unsure) 2) Do you know where to get help for mental health issues when you need to? (Yes, No, Unsure). The percentage of participants who answer "yes" to both questions will be assessed.
  arm group label: INFORMED-Living Well
  arm group type: Experimental
  description: INFORMED-Living Well consists of two components: 1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging. The LHW educational outreach component includes 2 small group educational sessions with 2-8 participants. Participants will also receive a weekly SMS Text or instant message on managing emotional wellness within and beyond the context of the COVID-19 pandemic over 6 weeks. In addition, participants will receive as-needed messages on updates of COVID-19 or other situations that may introduce new worries and tragic culturally-based traumatic events.
  arm group label: Text Messaging Only
  arm group type: Active Comparator
  description: Participants will have a 6-week SMS text messaging program identical to that received by the INFORMED-Living Well participants.
  intervention type: Behavioral
  intervention name: INFORMED-Living Well
  description: 1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging
  arm group label: INFORMED-Living Well
  intervention type: Behavioral
  intervention name: Text Messaging Only
  description: A 6-week automated SMS text messaging
  arm group label: Text Messaging Only
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Janice Tsoh, PhD
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: JiWon Choi, PhD
  phone: 415-514-2534
  email: jiwon.choi@ucsf.edu
  facility: 
  facility: 
  contact: 
  facility: 
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No