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

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: Active, not recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Self-help acceptance and commitment therapy with behavioral activation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Screening rate	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	Calculated as the number of eligible ethnic minority young adults divided by the number of screened ethnic minority young adults.	3 months
Consent rate	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	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	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	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	calculated the number of subjects who remain in the study, divided by the number of subjects who are randomized	6 weeks
Completion rate	calculated as the number of subjects who answer the questionnaires divided by the number of questionnaires distributed	6 weeks
Missing data	percentage of missing in the dataset. Unknown or blank values will be regarded	6 weeks
Adverse events	unfavorable and unintended events that are absent from baseline, or appear to worsen from baseline during the study period	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence rate	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	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	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	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

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2024
• Primary Completion (Estimated): March 28, 2025
• Study Completion (Estimated): April 28, 2025

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Alcohol abuse; Alcohol use disorder; Acceptance and commitment therapy; Behavioral activation; Ethnic minority young adults
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Alcoholism; Alcohol Drinking
• Other Study ID 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