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

NCT06779006 | Active Not Recruiting

• 1 other identifier: ACT-BA_AUD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Keywords

Acceptance and commitment therapy; Behavioral activation; Ethnic minority young adults; Alcohol abuse; Alcohol use disorder

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• Abstinence rate

  6 weeks

• Average number of drinks consumed per day

  6 weeks

• The number of drinking days

  6 weeks

• The number of heavy drinking days

  6 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

The control group will be assigned to receive Treatment as Usual (TAU).

Interventions

Self-help acceptance and commitment therapy with behavioral activation BEHAVIORAL

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: January 16, 2025
• Study Start: September 15, 2024
• Primary Completion: March 28, 2025
• Study Completion: April 28, 2025
• Last Updated: January 16, 2025

Record last verified: 2024-08

Locations

HK (1)