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/NCT05995470</url>
    </required_header>
    <id_info>
      <org_study_id>07210047</org_study_id>
      <nct_id>NCT05995470</nct_id>
    </id_info>
    <brief_title>Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Adult Drinkers</brief_title>
    <official_title>Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Reducing Alcohol Consumption and Improving Psychological Distress of Adult Drinkers: A Pilot Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese University of Hong Kong</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1. To determine the feasibility, acceptability, and preliminary effects of an&#xD;
             internet-based DBT-ST for reducing alcohol consumption and improving psychological&#xD;
             distress/emotional regulation in adult drinkers&#xD;
  &#xD;
          2. To explore the participants' experiences and perceptions of the proposed intervention&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Alcohol consumption</measure>
      <time_frame>Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention</time_frame>
      <description>The Chinese version of the Alcohol Use Disorders Identification Test-Concise (AUDIT-C)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of psychological distress</measure>
      <time_frame>Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention</time_frame>
      <description>Symptoms of depression, anxiety and stress</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-reported alcohol abstinence</measure>
      <time_frame>Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention</time_frame>
      <description>Self-reporting of quitting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotion dysregulation</measure>
      <time_frame>Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention</time_frame>
      <description>Levels of emotion dysregulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distress tolerance</measure>
      <time_frame>Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention</time_frame>
      <description>Perceived ability to tolerate emotional distress</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coping response</measure>
      <time_frame>Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention</time_frame>
      <description>Self-report measure of coping strategies</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Acceptability</measure>
      <time_frame>Post-intervention (upon completion of the 13-week DBT-ST)</time_frame>
      <description>Client Satisfaction</description>
    </other_outcome>
    <other_outcome>
      <measure>Feasibility of the intervention</measure>
      <time_frame>Post-intervention (upon completion of the 13-week DBT-ST)</time_frame>
      <description>1) Recruitment rate; (2) Intervention engagement in terms of time spent on each session and participation rates; and (3) Attrition rates</description>
    </other_outcome>
    <other_outcome>
      <measure>Semi-structured interview</measure>
      <time_frame>Post-intervention (upon completion of the 13-week DBT-ST)</time_frame>
      <description>Individual semi-structured interviews will be conducted at post-intervention to explore participants' experiences/perceptions of the internet-based DBT-ST, as well as their comments on the appropriateness/comprehensiveness of the content/frequency of the intervention.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">86</enrollment>
    <condition>Alcohol Drinking</condition>
    <arm_group>
      <arm_group_label>DBT-ST group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the intervention group will receive the DBT-ST by means of a free video-communication app. Over the next 13 weeks from the baseline, the intervention group will receive a weekly 120-minute internet-based DBT-ST focusing on the four modules of DBT-ST.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TAU group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants in the wait list control group will receive a monthly health education for three months that provides general health information and sharing sessions, which is one of the routine care for drinkers during the first 3-4 months after they seek help for drinking problem (waiting period for further intervention).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Internet-based dialectical behaviour therapy-informed skills training</intervention_name>
      <description>Adaptive applications of DBT-ST for drinkers with psychological distress</description>
      <arm_group_label>DBT-ST group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Monthly health education</intervention_name>
      <description>General health information and sharing sessions</description>
      <arm_group_label>TAU group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hong Kong Chinese aged ≥18&#xD;
  &#xD;
            -  Score ≥8 on the Alcohol Use Disorders Identification Test&#xD;
  &#xD;
            -  Indicate psychological distress as measured by the Depression, Anxiety, and Stress&#xD;
               Scale-21&#xD;
  &#xD;
            -  Have an intention to stop drinking&#xD;
  &#xD;
            -  Have an electronic device and are willing to receive interventions via the internet&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Experiencing psychotic disorders/cognitive impairment/communication problems&#xD;
  &#xD;
            -  Participating in other alcohol abstinence/related psychosocial interventions&#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>Long Kwan Ho, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Long Kwan Ho, PhD</last_name>
      <phone>39430664</phone>
      <email>longkwanho@cuhk.edu.hk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Ho Long Kwan</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Dialectical behaviour therapy</keyword>
    <keyword>Skills training</keyword>
    <keyword>Internet-based intervention</keyword>
    <keyword>Psychological distress</keyword>
    <keyword>Alcohol drinking</keyword>
    <keyword>Adult drinkers</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alcohol Drinking</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/NCT05995470
  org study id: 07210047
  nct id: NCT05995470
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  1. To determine the feasibility, acceptability, and preliminary effects of an
             internet-based DBT-ST for reducing alcohol consumption and improving psychological
             distress/emotional regulation in adult drinkers
  
          2. To explore the participants' experiences and perceptions of the proposed intervention
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Alcohol consumption
  time frame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
  description: The Chinese version of the Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
  measure: Level of psychological distress
  time frame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
  description: Symptoms of depression, anxiety and stress
  measure: Self-reported alcohol abstinence
  time frame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
  description: Self-reporting of quitting
  measure: Emotion dysregulation
  time frame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
  description: Levels of emotion dysregulation
  measure: Distress tolerance
  time frame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
  description: Perceived ability to tolerate emotional distress
  measure: Coping response
  time frame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
  description: Self-report measure of coping strategies
  measure: Acceptability
  time frame: Post-intervention (upon completion of the 13-week DBT-ST)
  description: Client Satisfaction
  measure: Feasibility of the intervention
  time frame: Post-intervention (upon completion of the 13-week DBT-ST)
  description: 1) Recruitment rate; (2) Intervention engagement in terms of time spent on each session and participation rates; and (3) Attrition rates
  measure: Semi-structured interview
  time frame: Post-intervention (upon completion of the 13-week DBT-ST)
  description: Individual semi-structured interviews will be conducted at post-intervention to explore participants' experiences/perceptions of the internet-based DBT-ST, as well as their comments on the appropriateness/comprehensiveness of the content/frequency of the intervention.
  arm group label: DBT-ST group
  arm group type: Experimental
  description: Participants in the intervention group will receive the DBT-ST by means of a free video-communication app. Over the next 13 weeks from the baseline, the intervention group will receive a weekly 120-minute internet-based DBT-ST focusing on the four modules of DBT-ST.
  arm group label: TAU group
  arm group type: Other
  description: Participants in the wait list control group will receive a monthly health education for three months that provides general health information and sharing sessions, which is one of the routine care for drinkers during the first 3-4 months after they seek help for drinking problem (waiting period for further intervention).
  intervention type: Behavioral
  intervention name: Internet-based dialectical behaviour therapy-informed skills training
  description: Adaptive applications of DBT-ST for drinkers with psychological distress
  arm group label: DBT-ST group
  intervention type: Behavioral
  intervention name: Monthly health education
  description: General health information and sharing sessions
  arm group label: TAU group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Long Kwan Ho, PhD
  role: Principal Investigator
  affiliation: Chinese University of Hong Kong
  last name: Long Kwan Ho, PhD
  phone: 39430664
  email: longkwanho@cuhk.edu.hk
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Ho Long Kwan
  investigator title: Assistant Professor
  mesh term: Alcohol Drinking