About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(1)aged 18-35 years,37-38
(2)able to read Chinese and speak Cantonese
(3)have AUDIT scores≥8.
Disqualifiers
(1) those who have a serious mental illness (Kessler Psychological Distress Scale7 with a score of ≥13)
Trial design
Sequential
Treatments tested in this trial
Telephone-based ACT
BehavioralEach 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 social support
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
self-reported 30-day alcohol abstinence
self-reported 30-day reduction in alcohol consumption
reduction in alcohol consumption refer to: 50% or more reduction in average alcohol consumption per day when compared with baseline at T0
psychological flexibility
Personalised Psychological Flexibility Index(PPFI) will be used to measure psychological flexibility by 19 items rating on a 7-point scale. Higher scores represent greater psychological flexibility. It has been validated among Chinese college students.
Locations
Sponsors and contacts
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