- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07501130
Feasibility of Telephone-based Acceptance and Commitment Therapy in Hong Kong Chinese Young Adults With Alcohol Use Disorder: A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kowloon, Hong Kong
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACT
Telephone-based Acceptance and Commitment Therapy (ACT) for young adults with Alcohol Use Disorder (AUD)
|
Participants in the experimental group will receive a total of 6 weekly telephone-based Acceptance and Commitment Therapy (ACT) sessions.
|
|
Placebo Comparator: Control
Telephone-based social support
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Participants in the control group will receive telephone-based social support weekly for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Screening rate
Time Frame: 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.
|
Baseline
|
|
Eligibility rate
Time Frame: Baseline
|
It will be calculated as the number of eligible young adults divided by the number of screened young adults.
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Baseline
|
|
Consent rate
Time Frame: Baseline
|
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
Time Frame: 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.
|
Baseline
|
|
Attendance rate to the intervention
Time Frame: at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
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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.
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at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
|
|
Adherence to intervention
Time Frame: 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.
|
at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
|
|
Retention rate
Time Frame: 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.
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at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
|
|
Completion rate
Time Frame: at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
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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
Time Frame: 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.
|
at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
|
|
Adverse event
Time Frame: at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
|
unfavorable and unintended events.
|
at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly alcohol consumption
Time Frame: 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.
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at 6-month (T2) follow-ups
|
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Psychological flexibility
Time Frame: 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.
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at 6-month (T2) follow-ups
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACT for young AUD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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