A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerging Adults

Not Applicable

Not yet recruiting

• Conditions: Alcohol Use Disorder

• Registration Number: NCT07214831
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

American emerging adults (EAs; aged 18-29 years) have the highest rates of alcohol use disorder (AUD) and the lowest levels of treatment engagement of any age group. Innovative, scalable, and cost-effective strategies are needed to expand early detection and intervention for EAs engaged in patterns of drinking associated with AUD. Because digital technology use is frequent among EAs, digital interventions may be a particularly suitable way to reach this population. Prior studies of digital alcohol interventions demonstrate modest but consistent reductions in alcohol use, but these tools are often limited by a lack of interactivity and personalization. Large language model (LLM)-based chatbots, such as ChatGPT, may address these limitations by enabling personalized, adaptive, and human-like engagement. These features have the potential to increase uptake and engagement with screening and brief interventions among EAs. This study will develop, validate, and conduct an open trial of an LLM-based chatbot-delivered brief intervention designed to reduce alcohol use and problems among EAs, with the primary goal of establishing preliminary feasibility and acceptability.

Detailed Description

This feasibility and acceptability study will develop, validate, and conduct a Phase I single-arm open trial of a large language model (LLM)-based chatbot-delivered brief intervention designed to reduce alcohol use and problems among EAs. To develop the augmented LLM, we will use instruction fine-tuning to enhance conversational abilities within the context of brief interventions based on high-fidelity recordings of sessions from prior clinical trials and simulated patient-provider interactions. A retrieval augmented generation system will be developed to ensure the model delivers accurate information. The augmented LLM will be incorporated into a chatbot interface delivered through a user-friendly web application. To validate the chatbot's capability for delivering brief alcohol interventions, patient actors (clinical or counseling psychology PhD students) will be assigned clinical vignettes depicting diverse EAs with patterns of drinking associated with alcohol use disorder. Patient actors will engage in two randomly ordered online text-based brief intervention sessions for each vignette (one with the chatbot and one with a human clinician). Blinded transcripts from sessions will be reviewed by experts to assess treatment fidelity. To maximize and test initial feasibility and acceptability of the intervention, we will conduct semi-structured interviews with 20 EAs who report hazardous drinking, followed by an open trial with another 20 EAs.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-06
• Study First Submitted QC: 2025-10-06
• Last Update Submitted: 2025-10-06
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2027-06-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 18-29 years old
• Engaged in past-month hazardous drinking (consuming ≥ 5/4 drinks for men/women on two or more occasions in the past month) or exceeded recommended guidelines for risky drinking (> 14/7 drinks per week for men/women)
• Able to read and comprehend English at a 5th grade level

Exclusion Criteria

• Report a history of or active psychosis
• Previous or current engagement in alcohol or drug treatment
• Risk for alcohol withdrawal as evidenced by very heavy weekly drinking reports on the alcohol screener (> 40 standard drinks in a typical week in the past month)
• Demonstrate inability or unwillingness to attend in-person office visits
• Demonstrate inability or unwillingness to identify an emergency contact who could be contacted in case the participant becomes lost to follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility - recruitment	Enrollment	Recruitment feasibility will be evaluated based on the length of time needed to recruit target enrollment (N = 20)
Feasibility - retention	1-month post intervention1-month post intervention	Retention feasibility will be achieved if \>80% of participants who consented to participating in the study complete one-month follow-up assessment.
Acceptability (System Usability Scale)	Immediate post-intervention session	Acceptability of the conversational agent-delivered intervention will be measured using the 10-item System Usability Scale. Each question is rated on a Likert-type scale ranging from (1) strongly disagree to (5) strongly agree.
Acceptability - intervention delivery method	Immediate post-intervention session	Percentage of participants who agree or strongly agree the intervention delivery method was acceptable
Acceptability - usable	Immediate post-intervention session	Percentage of participants who agree or strongly agree the intervention was easy to interact with
Acceptability - helpful	Immediate post-intervention session	Percentage of participants who agree or strongly agree the intervention was helpful
Acceptability - recommend to others	Immediate post-intervention session	Percentage of participants who agree or strongly agree they would recommend the chatbot to others

Secondary Outcome Measures

Name	Time	Method
Motivation to change drinking (Readiness Ruler)	Enrollment, immediate post-intervention session, and 1 month post-intervention	Motivation to change drinking will measured using the Readiness Ruler.
Daily drinking questionnaire (DDQ)	Enrollment and 1 month post-intervention	Past-month typical drinks per week and frequency of heavy drinking will be assessed using the DDQ. Respondents are asked to record the number of drinks they consume each day of a typical week over the previous month.
Alcohol Use Disorders Identification Test (AUDIT)	Enrollment and 1 month post-intervention	Past-month frequency of heavy drinking will be assessed using the AUDIT, a ten-item screening tool used to identify hazardous and harmful drinking patterns.
Young Adult Alcohol Consequences Questionnaire (YAACQ)	Enrollment and 1 month post-intervention	Alcohol-related problems will be assessed using the YAACQ. Respondents will be asked to indicate (yes/no) which of the 48 potential problems they have experienced as a result of their drinking over the previous month.
Protective behavioral strategies scale (PBSS)	Enrollment and 1 month post-intervention	Protective behavioral strategies will be assessed using the 15-item PBSS. Participants will be asked to indicate how often they used each strategy when drinking alcohol during the previous month. Response options are presented on a 6-point Likert type scale ranging from 1 (never) to 6 (always).
Alcohol treatment utilization	Enrollment and 1 month post-intervention	Alcohol treatment utilization, including a variety of options, will be measured by asking respondents to indicate (yes/no) which of the potential options they have utilized.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States