Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers

NCT07238998 | Recruiting

• 1 other identifier: 4-2025-1168
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate and compare the degree of alcohol reduction between high-risk drinkers who use a motivational interviewing-based conversational agent (chatbot) application for four weeks and those in the control group who do not use the application, in order to verify its clinical effectiveness.

Conditions

Alcohol Drinking; High-Risk Drinking Patterns

Outcome Measures

Primary Outcomes (1)

• Change in Past 7-Day Alcohol Consumption (Standard Drinks and Binge Drinking Frequency) From Baseline to Week 16

  Alcohol consumption during the past 7 days-including total standard drink units and binge drinking frequency-will be assessed at Week 0, Week 4, and Week 16 using validated self-report measures. The primary efficacy analysis will evaluate changes from baseline to Week 16 in both past 7-day standard alcohol consumption and past 7-day binge drinking episodes to determine the intervention's effectiveness in reducing high-risk alcohol use.

  Week 0 (Baseline), Week 4, and Week 16

Study Arms (2)

Chatbot Intervention Group

EXPERIMENTAL

Participants assigned to the experimental arm will use a motivational interviewing-based conversational agent (chatbot) mobile application for 4 weeks beginning on the baseline assessment day (Week 0). Reassessments will occur at Week 4, marking the end of the intervention period, and at Week 16, the three-month follow-up. All efficacy analyses comparing the two groups will be conducted over the Week 0-16 evaluation period.

Behavioral: Motivational Interviewing-Based Conversational Agent (Mobile Chatbot)

Waitlist Control Group

ACTIVE COMPARATOR

Participants assigned to the waitlist control arm will not receive any intervention during the primary evaluation period (Week 0-16). They will undergo the same reassessments as the intervention group at Week 4 and Week 16. After completing the Week 16 follow-up, participants in the control arm will be offered the same 4-week chatbot intervention for ethical considerations, followed by a final assessment at Week 20. However, this post-Week-16 intervention is not included in the primary efficacy analysis.

Other: No Intervention (Waitlist Control)

Interventions

Motivational Interviewing-Based Conversational Agent (Mobile Chatbot) BEHAVIORAL

Participants in the experimental arm will use a motivational interviewing-based conversational agent (mobile chatbot) for 4 weeks starting on the baseline assessment day (Week 0). The intervention provides daily interactive dialogues, personalized feedback, goal-setting guidance, and behavior change strategies based on motivational interviewing principles. Participants are encouraged to complete daily sessions designed to enhance motivation, support self-monitoring, and reduce high-risk alcohol consumption.

Also known as: MI Chatbot, Digital Behavioral Intervention

Chatbot Intervention Group

No Intervention (Waitlist Control) OTHER

Participants in the waitlist control arm will not receive any intervention during the primary evaluation period (Week 0-16). They will complete the same reassessments as the intervention group at Week 4 and Week 16. After the Week 16 follow-up, control arm participants will be offered the same 4-week chatbot intervention for ethical considerations, followed by a final assessment at Week 20. This post-Week-16 intervention is not included in the primary efficacy analysis.

Also known as: Waitlist Control, Delayed Intervention Control

Waitlist Control Group

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged 19 to 59 years who are capable of providing valid written informed consent.
• Individuals who meet the definition of high-risk drinking (AUDIT score ≥ 8).3.- Individuals who express a desire to reduce their alcohol consumption.
• Individuals who own and use an Android smartphone (version 8 or higher).
• Individuals who have no difficulty using mobile applications.
• Individuals who are able to communicate adequately with the research team.
• Individuals who fully understand the study procedures and voluntarily agree to participate.

You may not qualify if:

• Individuals who are unable to read or understand the consent form (e.g., illiterate individuals, non-Korean speakers).
• Individuals with impaired decision-making capacity.
• Pregnant individuals or those planning to become pregnant during the study period.
• Individuals who are currently participating in another clinical study.
• Individuals who are receiving treatment or counseling for alcohol-related problems.
• Individuals who use two or more mobile phones.
• Individuals who are expected to change their mobile phone or SIM card, or who plan to travel 8. abroad during the intervention period.
• Any individual deemed inappropriate for study participation at the discretion of the investigator.

Sponsors & Collaborators

• Yonsei University: lead
• BlueSignum Corporation: collaborator

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: December 19, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

KR (1)