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Active, Not Recruiting

NCT Number: NCT06779006

Effectiveness of Internet-Based Self-Help ACT With Behavioral Activation in Improving Alcohol Use Abstinence Among Ethnic Minority Young Adults With Alcohol Use Disorder

The goal of this clinical trial is to examine the preliminary effectiveness and feasibility of internet-based self-help acceptance and commitment therapy with behavioral activation for ethnic minority young adults with alcohol use disorder. The main questions it aims to answer are:

* Is the internet-based self-help acceptance and commitment therapy with Behavioral activation (self-help iACT-BA) feasible and acceptable for ethnic minority young adults with AUD? * Does the self-help iACT-BA promote greater abstinence from alcohol use compared to treatment as usual (TAU) in ethnic minority young adults diagnosed with AUD? Researchers will compare self-help iACT-BA to treatment as usual (TAU) to see if self-help iACT-BA works to treat alcohol use disorder in ethnic minority young adults.

Participants will:

* Received a self-help iACT-BA module every week for 6 weeks. or a placebo every day for 4 months * Access the module every week, read the material, practice, and complete home assignments.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hong Kong ethnic minority young adults
  • They have to read, write, and speak English
  • Their age will range from 18 to 25
  • They will be voluntary to participate
  • Participants should have smartphones or other electronic devices to access the internet
  • They must have AUD based on DSM-5 criteria.

Exclusion criteria

  • Currently having psychiatric problems, other mental health problems, being actively involved in suicidal attempts, or immediate care
  • Having a plan to go out of Hong Kong during intervention implementation
  • Having no access to the internet, smart telephone, or other electronic devices
  • Have participated in another psychosocial or pharmacological intervention for AUD.

Treatment and study plan

Self-help acceptance and commitment therapy with behavioral activation

Behavioral

Internet-based self-help acceptance and commitment therapy with behavioral activation

Primary outcomes

  1. Screening rate

    Time frame: 3 months

    calculated as the number of Hong Kong ethnic minority young adults screened by the research assistant divided by the number of Hong Kong ethnic minority young adults available for screening during the recruitment period.

  2. Eligibility rate

    Time frame: 3 months

    Calculated as the number of eligible ethnic minority young adults divided by the number of screened ethnic minority young adults.

  3. Consent rate

    Time frame: 3 months

    calculated as the number of eligible ethnic minority young adults who join the study divided by the number of eligible ethnic minority young adults.

  4. Randomization rate

    Time frame: 2 weeks

    calculated as the number of ethnic minority young adults who are randomized into the experimental and control groups, divided by the number of eligible ethnic minority young adults who consent to join the study

  5. Attendance rate

    Time frame: 6 weeks

    calculated as the number of subjects in the experimental group who complete the intervention divided by the number of subjects randomized into the experimental group.

  6. Adherence rate

    Time frame: 6 weeks

    calculated as the number of subjects in the experimental group who practice the ACT skills gained in the intervention divided by the number of subjects randomized into the experimental group

  7. Retention rate

    Time frame: 6 weeks

    calculated the number of subjects who remain in the study, divided by the number of subjects who are randomized

  8. Completion rate

    Time frame: 6 weeks

    calculated as the number of subjects who answer the questionnaires divided by the number of questionnaires distributed

  9. Missing data

    Time frame: 6 weeks

    percentage of missing in the dataset. Unknown or blank values will be regarded

  10. Adverse events

    Time frame: 6 weeks

    unfavorable and unintended events that are absent from baseline, or appear to worsen from baseline during the study period

Secondary outcomes

  1. Abstinence rate

    Time frame: 6 weeks

    It will be calculated by dividing the number of non-drinking days recorded during intervention by the total number of intervention days and multiplying the result by 100.

  2. Average number of drinks consumed per day

    Time frame: 6 weeks

    Calculated as the total number of drinks during the intervention period divided by the total number of intervention days.

  3. The number of drinking days

    Time frame: 6 weeks

    Calculated by counting the number of days on which a participant consumes alcohol during the intervention period.

  4. The number of heavy drinking days

    Time frame: 6 weeks

    The number of heavy drinking days during the intervention period (having 3 or more drinks per day for males and 4 or more drinks per day for females.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Effectiveness of Internet-Based Self-Help ACT With Behavioral Activation in Improving Alcohol Use Abstinence Among Ethnic Minority Young Adults With Alcohol Use Disorder in Hong Kong, 2024: A Pilot Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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