An interventional study of Motivational Interviewing-Based Conversational Agent (Mobile Chatbot) and No Intervention (Waitlist Control) in Alcohol Drinking and High-Risk Drinking Patterns, sponsored by Yonsei University. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Yonsei University · Not applicable, Interventional, and Prevention
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.
"This study is a randomized controlled trial (RCT) employing a waitlist control design to examine the effectiveness of a motivational interviewing-based conversational mobile application for high-risk drinkers.
After obtaining voluntary written consent, participants will complete a screening process that includes a clinical interview (MINI, DSM) and demographic data collection. Those who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to either the intervention group (n = 110) or the control group (n = 110).
For the intervention group, the total study period is 16 weeks and consists of three visits (week 0, 4, and 16). The control group will participate for 20 weeks and complete four visits (week 0, 4, 16, and 20). The final follow-up assessment for both groups will be conducted via telephone and online.
The intervention group will use the mobile app (chatbot) for 4 weeks beginning on the baseline assessment day (Visit 1). Re-assessments will be conducted at week 4 (Visit 2), marking the end of the intervention period, and again at week 16 (Visit 3), which occurs three months after the intervention.
The control group will not receive any intervention from baseline to week 16 and will complete the same reassessments at week 4 (Visit 2) and week 16 (Visit 3). After the week 16 assessment, the control group will also use the mobile app for 4 weeks and undergo a final evaluation at week 20 (Visit 4), following completion of their intervention period.
This waitlist control design allows for a rigorous comparison of outcomes between the two groups while ensuring that all participants eventually receive access to the intervention, supporting both ethical considerations and improved retention.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's planned enrollment of 220 is above the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
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Exclusion Criteria:
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)
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)
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
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
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 16
Plan to share: Undecided
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