NCT07501130

Brief Summary

Objective: The proposed study aims to develop a protocol of telephone-based Acceptance and Commitment Therapy (ACT) for Alcohol Use Disorder (AUD) and examine the feasibility of implementing such intervention among the Hong Kong Chinese young adults with AUD. Study design: A randomized controlled trial will be carried out. A convenience sample of 60 young adults with AUD will be recruited from the community. Subjects who are randomized into the experimental group which will receive a total of 6 weekly telephone-based ACT provided by an experienced health counsellor, or into the control group which will receive social support provided by a research assistant, that mimics the time and attention of the intervention. Feasibility measures will be collected at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups. Also, all subjects will be asked to complete a structured questionnaire to assess their alcohol use behaviours and psychological flexibility at the same time points. Main outcome measures: The primary outcomes are feasibility measures by descriptive statistics. The secondary outcome is the preliminary effectiveness of telephone-based ACT in alcohol abstinence at 6 months Data analysis: Multiple logistic regression will be used for analysis. Intention-to-treat analysis will be applied. Multiple imputations will be used to handle the missing data.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress80%
Apr 2023Apr 2027

Study Start

First participant enrolled

April 1, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

March 17, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

young adultsaccepectance and commitment therapytelephone-basedalcohol use disorderalcohol abstinence

Outcome Measures

Primary Outcomes (10)

  • Screening rate

    It will calculate the number of young adults screened by the research assistant divided by the number of young adults available for screening during the recruitment period.

    Baseline

  • Eligibility rate

    It will be calculated as the number of eligible young adults divided by the number of screened young adults.

    Baseline

  • Consent rate

    It will be calculated as the number of eligible young adults who join the study divided by the number of eligible young adults.

    Baseline

  • Randomization rate

    It will be calculated as the number of young adults who are randomized into the experimental and control groups, divided by the number of eligible young adults who consent to join the study.

    Baseline

  • Attendance rate to the intervention

    It will be 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.

    at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups

  • Adherence to intervention

    It will be 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. It will be calculated at each follow-up.

    at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups

  • Retention rate

    It will be calculated the number of subjects who remain in the study, divided by the number of subjects who are randomized. It will be calculated by groups at each follow-up.

    at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups

  • Completion rate

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

    at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups

  • Missing data

    It is defined as the percentage of missing in the dataset. Unknown or blank values will be regarded as missing.

    at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups

  • Adverse event

    unfavorable and unintended events.

    at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups

Secondary Outcomes (2)

  • Weekly alcohol consumption

    at 6-month (T2) follow-ups

  • Psychological flexibility

    at 6-month (T2) follow-ups

Study Arms (2)

ACT

EXPERIMENTAL

Telephone-based Acceptance and Commitment Therapy (ACT) for young adults with Alcohol Use Disorder (AUD)

Behavioral: ACT

Control

PLACEBO COMPARATOR

Telephone-based social support

Behavioral: Social support

Interventions

ACTBEHAVIORAL

Participants in the experimental group will receive a total of 6 weekly telephone-based Acceptance and Commitment Therapy (ACT) sessions.

ACT
Social supportBEHAVIORAL

Participants in the control group will receive telephone-based social support weekly for 6 weeks.

Control

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (1) aged 18 to 25 years,
  • (2) able to read Chinese and speak Cantonese
  • (3) drinking at hazardous levels as measured by the Alcohol Use Disorders Identification Test (AUDIT; score of ≥8)

You may not qualify if:

  • (1) those receiving other behavioural therapy for Alcohol Use Disorder (AUD)
  • (2) having a diagnosis of a psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

AlcoholismAlcohol Abstinence

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Study Design

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

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 30, 2026

Study Start

April 1, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations