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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT | Experimental | Telephone-based Acceptance and Commitment Therapy (ACT) for young adults with Alcohol Use Disorder (AUD) |
|
| Control | Placebo Comparator | Telephone-based social support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT | Behavioral | Participants in the experimental group will receive a total of 6 weekly telephone-based Acceptance and Commitment Therapy (ACT) sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Eligibility rate | It will be calculated as the number of eligible young adults divided by the number of screened young adults. | 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. | 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. | 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. | 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. | at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 6-month (T2) follow-ups |
| Psychological flexibility |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Kowloon | Hong Kong |
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| Social support | Behavioral | Participants in the control group will receive telephone-based social support weekly for 6 weeks. |
|
| 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. |
| 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. | 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. | at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) follow-ups |
| Adverse event | unfavorable and unintended events. | at baseline (T0), 3- (T1) and 6- (T2) and 12-month (T3) 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. |
| at 6-month (T2) follow-ups |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D064829 | Alcohol Abstinence |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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