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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Participants in the experimental group will receive a total of 6 weekly telephone-based Acceptance and Commitment Therapy (ACT) sessions.
Participants in the control group will receive telephone-based social support weekly for 6 weeks.
The Hong Kong Polytechnic University
Kowloon, Hong Kong
Screening rate
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.
Time frame: Baseline
Eligibility rate
It will be calculated as the number of eligible young adults divided by the number of screened young adults.
Time frame: Baseline
Consent rate
It will be calculated as the number of eligible young adults who join the study divided by the number of eligible young adults.
Time frame: Baseline
Randomization rate
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.
Time frame: Baseline
Attendance rate to the intervention
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.
Time frame: at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
Adherence to intervention
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.
Time frame: at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
Retention rate
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.
Time frame: at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
Completion rate
It is calculated as the number of subjects who answer the questionnaires divided by the number of questionnaires distributed.
Time frame: at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
Missing data
It is defined as the percentage of missing in the dataset. Unknown or blank values will be regarded as missing.
Time frame: at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
Adverse event
unfavorable and unintended events.
Time frame: at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups
Weekly alcohol consumption
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.
Time frame: at 6-month (T2) follow-ups
Psychological flexibility
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.
Time frame: at 6-month (T2) follow-ups
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