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

NCT07214831 | Not Yet Recruiting

• 2 other identifiers: 2025P001459R34AA032472
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (7)

• Time to achieve target enrollment

  Recruitment feasibility will be evaluated based on the length of time needed to recruit target enrollment (N = 20)

  Enrollment

• Rate of participant retention

  Retention feasibility will be achieved if \>80% of participants who consented to participating in the study complete one-month follow-up assessment.

  1-month post intervention1-month post intervention

• Acceptability (System Usability Scale)

  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.

  Immediate post-intervention session

• Acceptability - intervention delivery method

  Percentage of participants who agree or strongly agree the intervention delivery method was acceptable

  Immediate post-intervention session

• Acceptability - usable

  Percentage of participants who agree or strongly agree the intervention was easy to interact with

  Immediate post-intervention session

• Acceptability - helpful

  Percentage of participants who agree or strongly agree the intervention was helpful

  Immediate post-intervention session

• Acceptability - recommend to others

  Percentage of participants who agree or strongly agree they would recommend the chatbot to others

  Immediate post-intervention session

Secondary Outcomes (6)

• Motivation to change drinking (Readiness Ruler)

  Enrollment, immediate post-intervention session, and 1 month post-intervention

• Daily drinking questionnaire (DDQ)

  Enrollment and 1 month post-intervention

• Alcohol Use Disorders Identification Test (AUDIT)

  Enrollment and 1 month post-intervention

• Young Adult Alcohol Consequences Questionnaire (YAACQ)

  Enrollment and 1 month post-intervention

• Protective behavioral strategies scale (PBSS)

  Enrollment and 1 month post-intervention

Study Arms (1)

Large language model-based chatbot brief alcohol intervention

EXPERIMENTAL

All participants will interact with a large language model-based chatbot designed to deliver a brief alcohol intervention session.

Behavioral: Large language model-based chatbot brief alcohol intervention session

Interventions

Large language model-based chatbot brief alcohol intervention session BEHAVIORAL

The intervention is a large language model-based chatbot designed to delivered brief alcohol interventions using motivational interviewing-consistent strategies. The chatbot session will last approximately 45 minutes and will include a decisional balance exercise, feedback on drinking patterns, normative beliefs about drinking, alcohol-related consequences, goal setting, and harm-reduction strategies.

Large language model-based chatbot brief alcohol intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Alex M Russell, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex M Russell, PhD

CONTACT

617-724-0924; arussell11@mgh.harvard.edu

Samuel F Acuff, PhD

CONTACT

sacuff@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 9, 2025
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data (IPD) and supporting documents will be deposited in the NIAAA Data Archive (NIAAADA) hosted within the NIMH Data Archive. Data will be submitted within 6 months of collection and will be available after study completion, in perpetuity.
• Access Criteria: Data will be de-identified and available as public use data through the NIAAA Data Archive. Access requires submission of a data use request through the NIAAADA and agreement to the Terms of Use, which limit use to scientific research, prohibit attempts to identify participants, and require reporting of any breaches of confidentiality.

Locations

US (1)