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/NCT06024083</url>
    </required_header>
    <id_info>
      <org_study_id>Pro2023001220</org_study_id>
      <nct_id>NCT06024083</nct_id>
    </id_info>
    <brief_title>Skills Video Intervention for Chinese/Chinese Americans</brief_title>
    <official_title>DBT Skills Video Intervention for Chinese and Chinese American College Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rutgers, The State University of New Jersey</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rutgers, The State University of New Jersey</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>
        This is a study that aims to test a coping skills intervention delivered via brief animated&#xD;
        videos for Chinese and Chinese American college students. We are interested in seeing whether&#xD;
        this brief intervention that incorporates Western psychotherapy components and Eastern&#xD;
        philosophies would be perceived as relevant and useful for this culturally unique yet diverse&#xD;
        group. During the study, participants will (1) complete a 20-min online baseline&#xD;
        questionnaire; (2) complete a brief survey each day using a phone App for up to four weeks;&#xD;
        and may (3) receive a video each day during the intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Emotion regulation measured by a combination of questions</measure>
      <time_frame>daily for up to 4 weeks</time_frame>
      <description>A combination of questions on emotional states, context for emotions, how intolerable and distressing emotions are, use of emotion regulation strategies, perceived effectiveness of emotion regulation, and Patient-Reported Outcomes Measurement Information System Self-efficacy of Managing Emotions Short-form 4a (a 4-item measure of the confidence to manage emotional states rated using a 5-point Likert scale)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>General self efficacy measured by Patient-Reported Outcomes Measurement Information System General Self-Efficacy Short-form 4a</measure>
      <time_frame>daily for up to 4 weeks</time_frame>
      <description>A 4-item measure of the ability to successfully perform specific tasks and behaviors rated using a 5-point Likert scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability/usability of intervention measured by a combination of Likert-scale and open-ended questions</measure>
      <time_frame>daily following the delivery of each video for up to 2 weeks</time_frame>
      <description>A combination of questions that involve rating the acceptability and usability of skills videos (e.g., &quot;how useful do you think the skills will be&quot;) and open-ended questions on cultural relevance</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Emotion Regulation</condition>
    <condition>Self Efficacy</condition>
    <condition>Acceptability of Health Care</condition>
    <arm_group>
      <arm_group_label>Assessment only</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Acceptance-oriented skills followed by change-oriented skills</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Change-oriented skills followed by acceptance-oriented skills</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dialectical Behavior Therapy skills video intervention</intervention_name>
      <description>A series of 14 animated videos (9 acceptance-oriented and 5 change-oriented skills videos) available in both English and Mandarin Chinese.</description>
      <arm_group_label>Acceptance-oriented skills followed by change-oriented skills</arm_group_label>
      <arm_group_label>Change-oriented skills followed by acceptance-oriented skills</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 18 or older&#xD;
  &#xD;
            -  identifying as Chinese or Chinese American&#xD;
  &#xD;
            -  interested in learning coping skills to regulate emotions&#xD;
  &#xD;
            -  having a smart-phone compatible with the research mobile phone app&#xD;
  &#xD;
            -  matriculated at the local University for the current semester&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  currently receiving routine mental health services&#xD;
  &#xD;
            -  not able to read or write English&#xD;
  &#xD;
            -  not able to provide informed consent&#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>Qingqing Yin, M.S.</last_name>
      <role>Study Director</role>
      <affiliation>Rutgers, The State University of New Jersey</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shireen Rizvi, Ph.D</last_name>
      <phone>848-445-3914</phone>
      <email>slrizvi@gsapp.rutgers.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Qingqing Yin, M.S.</last_name>
      <phone>732-630-8690</phone>
      <email>qy93@rutgers.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
      <investigator_full_name>Shireen L. Rizvi, PhD, ABPP</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Dialectical Behavior Therapy</keyword>
    <keyword>Ecological Momentary Assessment</keyword>
    <keyword>Psychotherapy, Brief</keyword>
    <keyword>Culturally Competent Care</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/NCT06024083
  org study id: Pro2023001220
  nct id: NCT06024083
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a study that aims to test a coping skills intervention delivered via brief animated
        videos for Chinese and Chinese American college students. We are interested in seeing whether
        this brief intervention that incorporates Western psychotherapy components and Eastern
        philosophies would be perceived as relevant and useful for this culturally unique yet diverse
        group. During the study, participants will (1) complete a 20-min online baseline
        questionnaire; (2) complete a brief survey each day using a phone App for up to four weeks;
        and may (3) receive a video each day during the intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Emotion regulation measured by a combination of questions
  time frame: daily for up to 4 weeks
  description: A combination of questions on emotional states, context for emotions, how intolerable and distressing emotions are, use of emotion regulation strategies, perceived effectiveness of emotion regulation, and Patient-Reported Outcomes Measurement Information System Self-efficacy of Managing Emotions Short-form 4a (a 4-item measure of the confidence to manage emotional states rated using a 5-point Likert scale)
  measure: General self efficacy measured by Patient-Reported Outcomes Measurement Information System General Self-Efficacy Short-form 4a
  time frame: daily for up to 4 weeks
  description: A 4-item measure of the ability to successfully perform specific tasks and behaviors rated using a 5-point Likert scale
  measure: Acceptability/usability of intervention measured by a combination of Likert-scale and open-ended questions
  time frame: daily following the delivery of each video for up to 2 weeks
  description: A combination of questions that involve rating the acceptability and usability of skills videos (e.g., "how useful do you think the skills will be") and open-ended questions on cultural relevance
  arm group label: Assessment only
  arm group type: No Intervention
  arm group label: Acceptance-oriented skills followed by change-oriented skills
  arm group type: Experimental
  arm group label: Change-oriented skills followed by acceptance-oriented skills
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Dialectical Behavior Therapy skills video intervention
  description: A series of 14 animated videos (9 acceptance-oriented and 5 change-oriented skills videos) available in both English and Mandarin Chinese.
  arm group label: Acceptance-oriented skills followed by change-oriented skills
  arm group label: Change-oriented skills followed by acceptance-oriented skills
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Qingqing Yin, M.S.
  role: Study Director
  affiliation: Rutgers, The State University of New Jersey
  last name: Shireen Rizvi, Ph.D
  phone: 848-445-3914
  email: slrizvi@gsapp.rutgers.edu
  last name: Qingqing Yin, M.S.
  phone: 732-630-8690
  email: qy93@rutgers.edu
  responsible party type: Principal Investigator
  investigator affiliation: Rutgers, The State University of New Jersey
  investigator full name: Shireen L. Rizvi, PhD, ABPP
  investigator title: Professor
  sharing ipd: No