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

January 12, 2025 updated by: Dr Eva Ho, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Arm
The intervention group will receive online-based integrated ACT with BA therapy. The protocol of this therapy is adapted from the ACT manual, self-help protocols for mental health problems, and behavioral activation treatment for substance use and depression.
Behavioral: Self-help acceptance and commitment therapy with behavioral activation
Internet-based self-help acceptance and commitment therapy with behavioral activation
No Intervention: Control Arm
The control group will be assigned to receive Treatment as Usual (TAU).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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 months
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.
3 months
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
2 weeks
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 weeks
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
6 weeks
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
6 weeks
Completion rate
Time Frame: 6 weeks
calculated as the number of subjects who answer the questionnaires divided by the number of questionnaires distributed
6 weeks
Missing data
Time Frame: 6 weeks
percentage of missing in the dataset. Unknown or blank values will be regarded
6 weeks
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
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACT-BA_AUD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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