- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07621822
Telephone-Based Acceptance and Commitment Therapy for Young Adult Hazardous Drinkers
A Randomized Controlled Trial of Telephone-Based Acceptance and Commitment Therapy to Assist Young Adults With Hazardous or Harmful Alcohol Use to Quit Drinking
The goal of this clinical trial is to learn if telephone-based Acceptance and Commitment Therapy (ACT) works to help young adults with hazardous or harmful alcohol use quit drinking. It will also learn about the psychological effects of ACT on participants.
The main questions it aims to answer are:
- Does telephone-based ACT increase the number of participants who quit drinking, as confirmed by a urine test?
- Does telephone-based ACT help participants reduce their alcohol consumption and improve their psychological flexibility?
Researchers will compare telephone-based ACT to a telephone-based social support programme to see if ACT works to help young adults quit drinking.
Participants will:
- Receive telephone-based ACT or social support once a week for 6 weeks Complete questionnaires about their alcohol use and psychological flexibility.
- Keep a record of their daily alcohol consumption throughout the study using a standardised diary method.
- Provide a urine sample at the 6-month follow-up if they report having quit drinking
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ka Wai Katherine LAM, Doctor of Philosophy
- Phone Number: +852 27666420
- Email: kw-katherine.lam@polyu.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (1) aged 18-35 years
- (2) able to read Chinese and speak Cantonese
- (3) have AUDIT scores ≥ 8
Exclusion Criteria:
- (1) currently receiving other behavioural therapies for drinking
- (2) has serious mental illnesses, defined as a Kessler Psychological Distress Scale score ≥ 13
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telephone-Based ACT Intervention
Telephone-based Acceptance and Commitment Therapy for participants
|
Participants in the intervention group will receive six weekly telephone sessions of ACT (45-60 min each) from interventionist.
|
|
Other: Waitlist control with Telephone-Based Social Support
|
Participants in the control group will receive six weekly telephone sessions of social support (45 min each) from interventionist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemically-Validated Abstinence
Time Frame: T4 (6 months after the end of the intervention)
|
Participants who self-report quitting drinking in the past 30 days are tested for ethyl glucuronide (a by-product of alcohol metabolism) via urine strips to confirm abstinence biochemically.
|
T4 (6 months after the end of the intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Reported 30-Day Abstinence
Time Frame: T0 (baseline), T1 (immediately after completion of the 6-week intervention), T2 (1 month after completing the intervention), T3 (3 months after completing the intervention), T4 (6 months after completing the intervention)
|
Reduction in alcohol consumption and self-reported 30-day abstinence will be recorded using TLFB.
Participants will be asked to report the number of drinks they have consumed within the past 30 days.
|
T0 (baseline), T1 (immediately after completion of the 6-week intervention), T2 (1 month after completing the intervention), T3 (3 months after completing the intervention), T4 (6 months after completing the intervention)
|
|
Reduction in Alcohol Consumption
Time Frame: T1 (immediately after completion of the 6-week intervention), T2 (1 month after the intervention), T3 (3 months after the intervention), T4 (6 months after the intervention)
|
Defined as 50% or more reduction in average alcohol consumption per day compared to baseline, measured using the Timeline Follow-Back (TLFB) questionnaire.
|
T1 (immediately after completion of the 6-week intervention), T2 (1 month after the intervention), T3 (3 months after the intervention), T4 (6 months after the intervention)
|
|
Psychological Flexibility Index
Time Frame: T0 (baseline), T1 (immediately after completion of the 6-week intervention), T2 (1 month after completing the intervention), T3 (3 months after completing the intervention), T4 (6 months after completing the intervention)
|
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
|
T0 (baseline), T1 (immediately after completion of the 6-week intervention), T2 (1 month after completing the intervention), T3 (3 months after completing the intervention), T4 (6 months after completing the intervention)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACT Alcohol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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