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/NCT05965349</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00015538</org_study_id>
      <nct_id>NCT05965349</nct_id>
    </id_info>
    <brief_title>Healthy Mind, Healthy Living</brief_title>
    <acronym>HMHL</acronym>
    <official_title>Evaluation of a Mindfulness-based Intervention on Depression Among Older Korean American Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Asian American Resource and Information Network, Inc (AARIN)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Washington</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>
        Depression among older Korean Americans are rising. Mindfulness-based cognitive therapy&#xD;
        (MBCT) is an evidence-based intervention (EBI), effective for preventing depression relapse&#xD;
        and reducing depressive symptoms. To enhance feasibility, acceptability, and reach, a brief&#xD;
        version of MBCT has been developed and delivered by telephone (brief MBCT-T), but has only&#xD;
        been tested in primarily White samples. This study will test test the effect of brief MBCT-T&#xD;
        among older Korean Americans.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Older Asians with limited English proficiency have experienced the greatest increase in&#xD;
        depression before and during the COVID-19 pandemic compared to Whites, Blacks, and Hispanics.&#xD;
        Social distancing measures to lower the risk of exposure to COVID-19, a diminishing social&#xD;
        network, limited opportunities with social groups, and lack of access to culturally and&#xD;
        linguistically relevant health information have all contributed to increased depression among&#xD;
        older Asians. In addition, increases in hate speech and racist crimes against Asians have&#xD;
        created a hostile living environment for older Asians, further contributing to depression.&#xD;
  &#xD;
        Mindfulness-based cognitive therapy (MBCT) is effective for preventing depression relapse and&#xD;
        active depression. Our team has created a brief telephone-based MBCT which has been shown to&#xD;
        be acceptable primarily white primarily white population. The acceptability of MBCT among&#xD;
        older Korean Americans remain understudied.&#xD;
  &#xD;
        Community-based organizations (CBOs) are places for accessing federal and state programs,&#xD;
        receiving culturally and linguistically appropriate health education, and supporting and&#xD;
        socializing with other older Asians. Our preliminary study shows that 1) CBOs are ideal&#xD;
        settings for offering MBCT-T because they have the infrastructure, capacity, cultural&#xD;
        understanding, and trust of communities, and 2) many CBOs feel the urgency to address older&#xD;
        Asians' escalating rates of depression and asked for assistance with training and&#xD;
        implementation of MBCT-T.&#xD;
  &#xD;
        We will partner with a CBO that serves large older Korean American population to conduct a&#xD;
        pilot study to assess the acceptability, feasibility, and preliminary impact of a CBO&#xD;
        delivered MBCT program on depression among older Korean Americans.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 3, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Depression</measure>
      <time_frame>8 weeks</time_frame>
      <description>Inventory of Depressive Symptomatology QUIDS-SR</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep</measure>
      <time_frame>8 weeks</time_frame>
      <description>Sleep Quality PROMIS measure</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Mindfulness Based Cognitive Therapy</condition>
    <condition>Depression</condition>
    <condition>Sleep</condition>
    <condition>Anxiety Depression</condition>
    <arm_group>
      <arm_group_label>Group-based MBCT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A telephone-based, 8-week MBCT session including: (1) learning mindfulness skills; (2) practicing mindfulness skills in class and at home; and (3) dialogue and inquiry.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Healthy Mind, Healthy Living</intervention_name>
      <description>A telephone, 8-week MBCT workshop series ncluding: (1) learning mindfulness skills; (2) practicing mindfulness skills in class and at home; and (3) dialogue and inquiry.</description>
      <arm_group_label>Group-based MBCT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must: (1) self-identify as a Korean person, (2) be between the ages 55&#xD;
               and 89, (3) has mild to moderate depressive symptoms (scores between 5-14 when&#xD;
               assessed using Patient Health Questionnaire-9 (PHQ-9), (4) has limited English&#xD;
               proficiency (responds &quot;less than very well&quot; when asked &quot;how well do you speak&#xD;
               English&quot;?) and fluency in Korean (e.g. able to speak at a native level), and (5)&#xD;
               willing to give a written consent to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals will not be able to participate if they have any of the following&#xD;
               criteria: (1) major psychiatric diseases that would interfere with participants'&#xD;
               ability to participate in or receive the benefit from the mental health interventions&#xD;
               (e.g., bipolar disorder, schizophrenia, recent history of psychosis or mania, severe&#xD;
               depressive symptoms); (2) used drugs other than those required for medical reasons;&#xD;
               (3) serious medical conditions (e.g., poorly controlled diabetes, severe congestive&#xD;
               heart failure) that has not been stable for at least 3 months; (4) current active&#xD;
               suicidal or self-injurious behavior, potentially necessitating immediate treatment;&#xD;
               (5) general conditions that would impede participation in a group intervention (e.g.,&#xD;
               cognitive impairment, tendencies toward physical aggression); (65) prior history of&#xD;
               engaging in formal mindfulness-based interventions including mindfulness-based stress&#xD;
               reduction, MBCT, Acceptance and Commitment Therapy, and Dialectical Behavioral&#xD;
               Therapy; and (76) significant current meditation practice, specifically more than&#xD;
               three hours of insight/mindfulness/vipassana meditation per week.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Linda Ko, MPH,PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sonia Bishop, BS</last_name>
      <phone>206-685-2947</phone>
      <email>skbishop@uw.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Noah Segal, MS</last_name>
      <email>nsegal@uw.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Washington</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sonia K Bishop, BS</last_name>
        <phone>206-685-2947</phone>
        <email>skbishop@uw.edu</email>
      </contact>
      <contact_backup>
        <last_name>Noah Segal, MS</last_name>
        <email>nsegal@uw.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Linda Ko, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Linda Ko</investigator_full_name>
      <investigator_title>Professor: School of Public Health</investigator_title>
    </responsible_party>
    <keyword>Mindfulness Based Cognitive Therapy (MBCT)</keyword>
    <keyword>Korean Americans</keyword>
    <keyword>Group-based</keyword>
    <keyword>Depression</keyword>
    <keyword>Sleep</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <!-- 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/NCT05965349
  org study id: STUDY00015538
  nct id: NCT05965349
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Depression among older Korean Americans are rising. Mindfulness-based cognitive therapy
        (MBCT) is an evidence-based intervention (EBI), effective for preventing depression relapse
        and reducing depressive symptoms. To enhance feasibility, acceptability, and reach, a brief
        version of MBCT has been developed and delivered by telephone (brief MBCT-T), but has only
        been tested in primarily White samples. This study will test test the effect of brief MBCT-T
        among older Korean Americans.
  Older Asians with limited English proficiency have experienced the greatest increase in
        depression before and during the COVID-19 pandemic compared to Whites, Blacks, and Hispanics.
        Social distancing measures to lower the risk of exposure to COVID-19, a diminishing social
        network, limited opportunities with social groups, and lack of access to culturally and
        linguistically relevant health information have all contributed to increased depression among
        older Asians. In addition, increases in hate speech and racist crimes against Asians have
        created a hostile living environment for older Asians, further contributing to depression.
  
        Mindfulness-based cognitive therapy (MBCT) is effective for preventing depression relapse and
        active depression. Our team has created a brief telephone-based MBCT which has been shown to
        be acceptable primarily white primarily white population. The acceptability of MBCT among
        older Korean Americans remain understudied.
  
        Community-based organizations (CBOs) are places for accessing federal and state programs,
        receiving culturally and linguistically appropriate health education, and supporting and
        socializing with other older Asians. Our preliminary study shows that 1) CBOs are ideal
        settings for offering MBCT-T because they have the infrastructure, capacity, cultural
        understanding, and trust of communities, and 2) many CBOs feel the urgency to address older
        Asians' escalating rates of depression and asked for assistance with training and
        implementation of MBCT-T.
  
        We will partner with a CBO that serves large older Korean American population to conduct a
        pilot study to assess the acceptability, feasibility, and preliminary impact of a CBO
        delivered MBCT program on depression among older Korean Americans.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Depression
  time frame: 8 weeks
  description: Inventory of Depressive Symptomatology QUIDS-SR
  measure: Sleep
  time frame: 8 weeks
  description: Sleep Quality PROMIS measure
  arm group label: Group-based MBCT
  arm group type: Experimental
  description: A telephone-based, 8-week MBCT session including: (1) learning mindfulness skills; (2) practicing mindfulness skills in class and at home; and (3) dialogue and inquiry.
  intervention type: Behavioral
  intervention name: Healthy Mind, Healthy Living
  description: A telephone, 8-week MBCT workshop series ncluding: (1) learning mindfulness skills; (2) practicing mindfulness skills in class and at home; and (3) dialogue and inquiry.
  arm group label: Group-based MBCT
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 89 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Linda Ko, MPH,PhD
  role: Principal Investigator
  affiliation: University of Washington
  last name: Sonia Bishop, BS
  phone: 206-685-2947
  email: skbishop@uw.edu
  last name: Noah Segal, MS
  email: nsegal@uw.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Linda Ko
  investigator title: Professor: School of Public Health
  mesh term: Depression
  mesh term: Depressive Disorder