NCT07450248

Brief Summary

Objectives: To investigate the effectiveness of a telephone-based acceptance and commitment therapy (ACT) in assisting young adult drinkers with hazardous or harmful alcohol use (HH drinkers) to quit drinking. Hypothesis to be tested: Primary hypothesis: 1) those who receive telephone-based ACT will report a significantly higher biochemical validated abstinence than the control groups. Secondary hypotheses are that compared with the control groups, those who receive telephone-based ACT will show: 2) significantly higher self-reported 30-day abstinence, 3) significantly greater reduction in drinking, and 4) significantly higher psychological flexibility. Design and subjects: A Hong Kong randomized controlled trial with 2-arm waitlist controlled trial design on 288 individuals (aged 18-35 years, able to read Chinese and speak Cantonese, and with AUDIT scores≥8). Study instruments: Biochemical-validated abstinence (Urine strips), timeline Follow-Back questionnaire, self-reported 30-day abstinence and Personalized Psychological Flexibility Index, Short-Form 6 Dimensions and semi-structured interviews. Interventions: The intervention group(n=144) will receive 6-weekly telephone-based ACT. The waitlist control group (n=144) will receive 6-weekly telephone-based social support intervention. Main outcome measures: Primary outcome is biochemical-validated abstinence at the 6-month follow-up. Secondary outcomes include self-reported 30-day abstinence alcohol reduction, and psychological flexibility at baseline, post-program, 1-, 3-, and 6-month follow-ups. Data analysis: Descriptive statistics, generalized estimating equations, multiple imputation, intention-to-treat, per protocol analyses, and cost-effectiveness analysis. Expected results: The telephone-based ACT is effective in assisting HH drinkers to quit drinking.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

March 4, 2026

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

December 12, 2025

Last Update Submit

February 27, 2026

Conditions

Keywords

young adultsAcceptance and Commitment TherapyTelephone-basedalcohol abstinence

Outcome Measures

Primary Outcomes (1)

  • biochemically-validated abstinence

    The urine strips will be used for testing the content of ethyl glucuronide(a by-product of alcohol). Participants who self-report quitting drinking within the past 30 days at the 6-month follow-up will be invited to do the test.

    at the 6-month follow-up

Secondary Outcomes (3)

  • self-reported 30-day alcohol abstinence

    at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups

  • self-reported 30-day reduction in alcohol consumption

    at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups

  • psychological flexibility

    at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups

Study Arms (2)

Telephone-based ACT

EXPERIMENTAL

Telephone-based ACT for alcohol abstinence

Behavioral: Telephone-based ACT

Waitlist control

PLACEBO COMPARATOR

Telephone-based social support

Behavioral: Telephone-based social support

Interventions

Each participant will join a six-session weekly telephone-based ACT programme conducted by the interventionists. Each session will last approximately 45-60 minutes.

Telephone-based ACT

Participants will receive weekly 45-minute telephone-based social support from an interventionist(not involved in the intervention group) for 6 weeks, which mimics the time and attention received by those in the intervention group.

Waitlist control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (1)aged 18-35 years,37-38
  • (2)able to read Chinese and speak Cantonese
  • (3)have AUDIT scores≥8.

You may not qualify if:

  • (1) those who have a serious mental illness (Kessler Psychological Distress Scale7 with a score of ≥13)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcohol Abstinence

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Central Study Contacts

Ka Wai Katherine LAM, Doctor of Philosophy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 12, 2025

First Posted

March 4, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

March 4, 2026

Record last verified: 2025-12