- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07450248
The Use of Telephone-based ACT for Quitting Alcohol in the Young Population With Hazardous or Harmful Alcohol Use.
A Randomized Controlled Trial of Telephone-based Acceptance and Commitment Therapy to Assist Young Adults With Hazardous or Harmful Alcohol Use to Quit Drinking
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 Overview
Status
Conditions
Intervention / Treatment
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,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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telephone-based ACT
Telephone-based ACT for alcohol abstinence
|
Each participant will join a six-session weekly telephone-based ACT programme conducted by the interventionists.
Each session will last approximately 45-60 minutes.
|
|
Placebo Comparator: Waitlist control
Telephone-based social support
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at the 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
Time Frame: at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups
|
reduction in alcohol consumption refer to: 50% or more reduction in average alcohol consumption per day when compared with baseline at T0
|
at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups
|
|
psychological flexibility
Time Frame: at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups
|
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.
|
at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- telephone-based ACT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Abstinence
-
UConn HealthNational Institute on Drug Abuse (NIDA)CompletedAlcohol UseUnited States
-
The Hong Kong Polytechnic UniversityActive, not recruitingAlcohol Use Disorder | Alcohol AbstinenceHong Kong
-
Grigore T. Popa University of Medicine and PharmacyAssociation of Alcoholics in Recovery Clubs Don OrioneEnrolling by invitationAlcohol AbstinenceRomania
-
University of HawaiiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedTissue and Organ Procurement | Alcohol AbstinenceUnited States
-
Endourage, LLCWithdrawnAlcohol Drinking | Alcohol-Related Disorders | Alcohol Use, Unspecified | Alcohol AbstinenceUnited States
-
University of Illinois at ChicagoNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Recruiting
-
Mclean HospitalCompletedAlcohol Drinking | Alcohol Use Disorder | Alcohol AbstinenceUnited States
-
Johns Hopkins UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Not yet recruitingCraving | Alcohol Use Disorder (AUD) | Withdrawal From Addictive Substance; DetoxificationUnited States
-
Centre Hospitalier Henri LaboritCompleted
-
Behavior Therapy Associates, LLPCompletedHeavy Drinking | Driving Under the Influence | Alcohol Abstinence | Driving While IntoxicatedUnited States
Clinical Trials on Telephone-based ACT
-
The Hong Kong Polytechnic UniversityNot yet recruitingHazardous Drinking | Harmful Alcohol Use
-
University of NottinghamUnknownCarer Stress SyndromeUnited Kingdom
-
Region SkaneWithdrawnCancer | Psychological DistressSweden
-
Vanderbilt University Medical CenterU.S. Department of EducationCompletedTraumatic Brain InjuryUnited States
-
The Hong Kong Polytechnic UniversityRecruitingParental Stress | Depression, Anxiety | Acceptance and Commitment Therapy | Psychological Flexibility | Randomised Controlled Trial | Child With Medical ComplexityChina, Hong Kong
-
Istituto Auxologico ItalianoRecruitingCerebrovascular Disorders | Amyotrophic Lateral Sclerosis | Frontotemporal Degeneration | Alzheimer's Disease | Lewy Body DementiaItaly
-
University of CyprusUniversity of CreteUnknown
-
Ataturk UniversityNot yet recruiting
-
University of Social Sciences and Humanities, WarsawNational Science Centre, PolandRecruitingHematopoietic Cell Transplantation Recipient | Acceptance and Commitment TherapyPoland