A Randomized Controlled Trial of Telephone-based Acceptance and Commitment Therapy to Assist Young Adults With Hazardous or Harmful Alcohol Use to Quit Drinking
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 288
- Primary Endpoint
- biochemically-validated abstinence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1)aged 18-35 years,37-38
- •(2)able to read Chinese and speak Cantonese
- •(3)have AUDIT scores≥8.
Exclusion Criteria
- •(1) those who have a serious mental illness (Kessler Psychological Distress Scale7 with a score of ≥13)
Arms & Interventions
Telephone-based ACT
Telephone-based ACT for alcohol abstinence
Intervention: Telephone-based ACT (Behavioral)
Waitlist control
Telephone-based social support
Intervention: Telephone-based social support (Behavioral)
Outcomes
Primary Outcomes
biochemically-validated abstinence
Time Frame: at the 6-month follow-up
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(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)
Investigators
Dr Katherine Lam
Assistant Professor
The Hong Kong Polytechnic University