NCT07381868

Brief Summary

This proposed study aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model that combines brief psychological counselling, Ecological Momentary Assessment (EMA) and social media psychosocial support group to reduce alcohol consumption in women.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jan 2026Nov 2026

First Submitted

Initial submission to the registry

December 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

February 2, 2026

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

December 17, 2025

Last Update Submit

January 27, 2026

Conditions

Keywords

psychosocial supportalcohol consumptionadult womensocial mediareduce alcohol intake

Outcome Measures

Primary Outcomes (1)

  • Alcohol use

    Alcohol use is measured by the Alcohol Use Disorders Identification Test (AUDIT) scale. It is a standardized, 10-item self-report screening instrument developed by the World Health Organization (WHO) to identify hazardous alcohol consumption, harmful drinking behaviors, and alcohol use disorders (AUDs). Respondents rate each item on a 5-point Likert scale (0 = never to 4 = daily or almost daily), with total scores ranging from 0 to 40. The higher the score, the greater the risk of individual alcohol abuse and dependence. Established cutoff values guide interpretation: Scores 0-7: Generally indicates low-risk or abstinence. Scores 8-14: Suggests hazardous or harmful alcohol use. Scores 15-19: Indicates a high level of harmful alcohol use. Simple advice and periodic review are advised. Scores 20-40: Suggests a likely alcohol dependence syndrome and the need for further diagnostic evaluation and specialist treatment consideration.

    4-, 8-, and 12-weeks after enrollment

Secondary Outcomes (4)

  • Anxiety

    4-, 8-, and 12-weeks after enrollment

  • Depressive symptoms

    4-, 8-, and 12-weeks after enrollment

  • Stress

    4-, 8-, and 12-weeks after enrollment

  • Perceived family well-being

    4-, 8-, and 12-weeks after enrollment

Study Arms (2)

Conrtol group

ACTIVE COMPARATOR

Participatns in the control group will receive alcohol brief intervention according to their AUDIT score at baseline and 4 weeks 1-to-1 health education messages.

Behavioral: Brief alcohol use counselling and health education

Intervention group

EXPERIMENTAL

A 4-week psychological support group for interactive counselling will be provided to encourage reducing alcohol consumption. MHealth messages will also be provided according to the stages of change for alcohol use.

Behavioral: mHealth-based motivational counsellingBehavioral: Brief alcohol use counselling and health educationBehavioral: Social media group support with engagement management

Interventions

The mHealth intervention will be delivered via the most popular instant messaging app in Hong Kong (WhatsApp). A total of 12 instant messages of six themes in multi-media formats, including text, pictures, animation, and short videos, will be sent to the participants according to the stages of change for alcohol use. Pre-contemplation: provide information about the risks of drinking; Contemplation: Emphasize the benefits of reduction and quitting, discuss alcohol problems and achievable goals for reduction or quitting; Preparation: discuss goal and give advice and encouragement; Action: review advice and provide encouragement; and Maintenance: give encouragement.Using a more personalized approach, the messages will be tailored to the participants' motivation, intention to quit and other quitting patterns collected at baseline. Real-time conversations could be initiated by participants themselves, triggered by regular messages, or through prompt inquires.

Intervention group

After randomization and baseline data collection, participants will be linked to an experienced behavior counsellor and to receive a brief alcohol use counselling with health education, including health risks in alcohol use, advice to reduce alcohol consumption and available alcohol use services in Hong Kong with self-help psychoeducational materials. Guided by WHO, personal feedback will be provided according to Alcohol Use Disorders Identification Test (AUDIT) score: 8-15 indicates at-risk for alcohol use, 16-19 indicates potentially harmful or hazardous drinking, and ≥20 indicates alcohol dependence. For subjects with potential risky drinking (3-8), AUDIT score will be explained and readiness to change drinking habits will be assessed.

Conrtol groupIntervention group

The behavior counsellor will invite the participants to join a psychological support group for interactive counselling. Counsellor will lead the discussion and provide counselling according to the stages of change for alcohol use. Pre-contemplation: provide information about the risks of drinking; Contemplation: Emphasize the benefits of reduction and quitting, discuss alcohol problems and achievable goals for reduction or quitting; Preparation: discuss goal and give advice and encouragement; Action: review advice and provide encouragement; and Maintenance: give encouragement. Participants will be encouraged to interact with counsellor on any concerns about healthy lifestyle, mood fluctuation, and other ways to deal with cravings.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult women (age 18+),
  • Had a total score ≥3 in AUDIT-C \[suggesting at-risk drinkers (i.e., binge drinking)\]( potential distress symptoms),
  • Able to read and understand Chinese and use an instant messaging app weekly

You may not qualify if:

  • Women who are undergoing psychiatric/psychological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health, The University of Hong Kong, 18/F, Metro South Tower 1, 39 Wong Chuk Hang Road, Wong Chuk Hang, 999077

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

February 2, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

February 2, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations