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Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Adult Drinkers

Primary Purpose

Alcohol Drinking

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-based dialectical behaviour therapy-informed skills training
Monthly health education
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol Drinking focused on measuring Dialectical behaviour therapy, Skills training, Internet-based intervention, Psychological distress, Alcohol drinking, Adult drinkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Hong Kong Chinese aged ≥18 Score ≥8 on the Alcohol Use Disorders Identification Test Indicate psychological distress as measured by the Depression, Anxiety, and Stress Scale-21 Have an intention to stop drinking Have an electronic device and are willing to receive interventions via the internet Exclusion Criteria: Experiencing psychotic disorders/cognitive impairment/communication problems Participating in other alcohol abstinence/related psychosocial interventions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    DBT-ST group

    TAU group

    Arm 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.

    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).

    Outcomes

    Primary Outcome Measures

    Alcohol consumption
    The Chinese version of the Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
    Level of psychological distress
    Symptoms of depression, anxiety and stress

    Secondary Outcome Measures

    Self-reported alcohol abstinence
    Self-reporting of quitting
    Emotion dysregulation
    Levels of emotion dysregulation
    Distress tolerance
    Perceived ability to tolerate emotional distress
    Coping response
    Self-report measure of coping strategies

    Full Information

    First Posted
    August 2, 2023
    Last Updated
    August 8, 2023
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05995470
    Brief Title
    Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Adult Drinkers
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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 To explore the participants' experiences and perceptions of the proposed intervention

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking
    Keywords
    Dialectical behaviour therapy, Skills training, Internet-based intervention, Psychological distress, Alcohol drinking, Adult drinkers

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DBT-ST group
    Arm Type
    Experimental
    Arm 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 Title
    TAU group
    Arm Type
    Other
    Arm 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(s)
    Internet-based dialectical behaviour therapy-informed skills training
    Intervention Description
    Adaptive applications of DBT-ST for drinkers with psychological distress
    Intervention Type
    Behavioral
    Intervention Name(s)
    Monthly health education
    Intervention Description
    General health information and sharing sessions
    Primary Outcome Measure Information:
    Title
    Alcohol consumption
    Description
    The Chinese version of the Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
    Time Frame
    Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
    Title
    Level of psychological distress
    Description
    Symptoms of depression, anxiety and stress
    Time Frame
    Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
    Secondary Outcome Measure Information:
    Title
    Self-reported alcohol abstinence
    Description
    Self-reporting of quitting
    Time Frame
    Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
    Title
    Emotion dysregulation
    Description
    Levels of emotion dysregulation
    Time Frame
    Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
    Title
    Distress tolerance
    Description
    Perceived ability to tolerate emotional distress
    Time Frame
    Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
    Title
    Coping response
    Description
    Self-report measure of coping strategies
    Time Frame
    Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
    Other Pre-specified Outcome Measures:
    Title
    Acceptability
    Description
    Client Satisfaction
    Time Frame
    Post-intervention (upon completion of the 13-week DBT-ST)
    Title
    Feasibility of the intervention
    Description
    1) Recruitment rate; (2) Intervention engagement in terms of time spent on each session and participation rates; and (3) Attrition rates
    Time Frame
    Post-intervention (upon completion of the 13-week DBT-ST)
    Title
    Semi-structured interview
    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.
    Time Frame
    Post-intervention (upon completion of the 13-week DBT-ST)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Hong Kong Chinese aged ≥18 Score ≥8 on the Alcohol Use Disorders Identification Test Indicate psychological distress as measured by the Depression, Anxiety, and Stress Scale-21 Have an intention to stop drinking Have an electronic device and are willing to receive interventions via the internet Exclusion Criteria: Experiencing psychotic disorders/cognitive impairment/communication problems Participating in other alcohol abstinence/related psychosocial interventions
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Long Kwan Ho, PhD
    Phone
    39430664
    Email
    longkwanho@cuhk.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Long Kwan Ho, PhD
    Organizational Affiliation
    Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Adult Drinkers

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