The Use of Telephone-based ACT for Quitting Alcohol in the Young Population With Hazardous or Harmful Alcohol Use.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorThe Hong Kong Polytechnic University

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 volunteers

Qualifiers

(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

Design model

Sequential

Treatments tested in this trial

  • Telephone-based ACT

    Behavioral

    Each 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

    Behavioral

    Participants 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

288 Participants
are divided into 2 treatment groups
Group A: Telephone-based ACTExperimental treatment 1 intervention
Group B: Waitlist controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at the 6-month follow-up

Secondary outcomes

1

self-reported 30-day alcohol abstinence

Time frame
at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups
2

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

Time frame
at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups
3

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.

Time frame
at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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