Alcohol DrinkingNCT07238998
Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers
A study testing Motivational Interviewing-Based Conversational Agent (Mobile Chatbot) in people with Alcohol Drinking and High-Risk Drinking Patterns, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 59 years
- Conditions the study is for
- Alcohol Drinking, High-Risk Drinking Patterns
- What is being tested?
- Motivational Interviewing-Based Conversational Agent (Mobile Chatbot)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seoul, 03722
Young Chul Jung, Professor, MD, PhD, +82-2-2228-1620, eugenejung@yuhs.ac
About this study
Official title: Evaluating the Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers
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.
Read the detailed description
"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.
- Conditions
- Alcohol Drinking, High-Risk Drinking Patterns
- Being tested
- Motivational Interviewing-Based Conversational Agent (Mobile Chatbot), No Intervention (Waitlist Control)
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing-Based Conversational Agent (Mobile Chatbot)Behavioural
Also called MI Chatbot, Digital Behavioral Intervention
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.
No Intervention (Waitlist Control)Other
Also called Waitlist Control, Delayed Intervention Control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No Intervention (Waitlist Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 (Baseline), Week 4, and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start19 Dec 2025
- Primary completionNov 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- BlueSignum Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238998
- Sponsor's protocol ID
- 4-2025-1168
- Status last verified
- May 2026
- First submitted
- 16 Nov 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers
- ClinicalTrials.gov ID
- NCT07238998
- Acronym / sponsor ID
- 4-2025-1168
- Conditions
- Alcohol Drinking, High-Risk Drinking Patterns
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- BlueSignum Corporation
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot Intervention Group | Experimental | Behavioral: Motivational Interviewing-Based Conversational Agent (Mobile Chatbot)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. |
| Waitlist Control Group | Active comparator | Other: No Intervention (Waitlist Control)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. |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing-Based Conversational Agent (Mobile Chatbot)Also: MI Chatbot, Digital Behavioral InterventionParticipants 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. | Behavioural | Chatbot Intervention Group |
| No Intervention (Waitlist Control)Also: Waitlist Control, Delayed Intervention ControlParticipants 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. | Other | Waitlist Control Group |
Primary outcome
Change in Past 7-Day Alcohol Consumption (Standard Drinks and Binge Drinking Frequency) From Baseline to Week 16
Time frame: Week 0 (Baseline), Week 4, and 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing-Based Conversational Agent (Mobile Chatbot) in people with Alcohol Drinking and High-Risk Drinking Patterns, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Past 7-Day Alcohol Consumption (Standard Drinks and Binge Drinking Frequency) From Baseline to Week 16 (time frame: Week 0 (Baseline), Week 4, and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.