Feasibility of Telephone-based Acceptance and Commitment Therapy in Hong Kong Chinese Young Adults With Alcohol Use Disorder: A Pilot Study

NCT07501130 — Not applicable, Active not recruiting, 60 participants, The Hong Kong Polytechnic University

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Registry	NCT07501130
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Estimated)
Sponsor	The Hong Kong Polytechnic University (Other)
Conditions	Alcohol Use Disorder, Alcohol Abstinence
Interventions	ACT, Social support (Behavioral)
Dates	start 2023-04-01, primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-03-30, last updated 2026-03-30
Locations	1 site in Hong Kong

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
ACT	Experimental	Behavioral: ACT	Telephone-based Acceptance and Commitment Therapy (ACT) for young adults with Alcohol Use Disorder (AUD)
Control	Placebo comparator	Behavioral: Social support	Telephone-based social support

ACT (Behavioral): Participants in the experimental group will receive a total of 6 weekly telephone-based Acceptance and Commitment Therapy (ACT) sessions.
Social support (Behavioral): Participants in the control group will receive telephone-based social support weekly for 6 weeks.

+Outcome measures

Primary outcomes

Screening rate [Baseline]: 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.
Eligibility rate [Baseline]: It will be calculated as the number of eligible young adults divided by the number of screened young adults.
Consent rate [Baseline]: It will be calculated as the number of eligible young adults who join the study divided by the number of eligible young adults.
Randomization rate [Baseline]: 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.
Attendance rate to the intervention [at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups]: 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.
Adherence to intervention [at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups]: 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.
Retention rate [at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups]: 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.
Completion rate [at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups]: It is calculated as the number of subjects who answer the questionnaires divided by the number of questionnaires distributed.
Missing data [at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups]: It is defined as the percentage of missing in the dataset. Unknown or blank values will be regarded as missing.
Adverse event [at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups]: unfavorable and unintended events.

Secondary outcomes

Weekly alcohol consumption [at 6-month (T2) follow-ups]: Drinks per week over the past 30 days. The Timeline Follow-Back questionnaire (TLFB) will be used to determine the number of alcohol-free days from drinking days, and the number of drinks consumed per day.
Psychological flexibility [at 6-month (T2) follow-ups]: The Acceptance and Action Questionnaire II (AAQII) will be used to measure psychological flexibility. This questionnaire contains 7 items, with each rated on a 7-point scale, from 1 (never true) to 7 (always true). Lower scores indicate greater levels of psychological flexibility.

+Eligibility

Sex: All, ages: 18 Years to 25 Years

Inclusion Criteria:

* (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)

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
The Hong Kong Polytechnic University	Kowloon	Hong Kong

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