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Clinical Trials/NCT06779006
NCT06779006Active, not recruitingNot Applicable

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 Hong Kong Polytechnic University1 site in 1 country40 target enrollmentStarted: September 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
40
Locations
1
Primary Endpoint
Screening rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: Self-help acceptance and commitment therapy with behavioral activation (Behavioral)

Control Arm

No Intervention

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

Outcomes

Primary Outcomes

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.

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.

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.

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

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.

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

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

Completion rate

Time Frame: 6 weeks

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

Missing data

Time Frame: 6 weeks

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

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

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Eva Ho

Associate professor

The Hong Kong Polytechnic University

Study Sites (1)

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