Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-59
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Motivational Interviewing-Based Conversational Agent (Mobile Chatbot)
BehavioralParticipants 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.
No Intervention (Waitlist Control)
Other interventionParticipants 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Chatbot Intervention GroupExperimental treatment 1 intervention
Group B: Waitlist Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Week 0 (Baseline), Week 4, and Week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yonsei University
Lead sponsor
BlueSignum Corporation
Collaborator
Source ClinicalTrials.gov