Efficacy of a Fully Automated Electronic Screening and Brief Intervention to Reduce Harmful Alcohol Consumption: A Randomized Clinical Trial

NCT07675447 | Completed

• 1 other identifier: InCor/HCFMUSP
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

Brief Summary

This epidemiological study (randomized clinical trial) aims to evaluate a digital Screening and Brief Intervention (e-SBI) system for reducing and preventing harmful alcohol consumption in patients treated by the Brazilian Unified Health System (SUS), compared to an in-person SBI protocol.

Conditions

Binge Drinking; Harmful Use of Alcohol

Keywords

Harmful alcohol consumption; Screening and Brief Intervention; electronic Screening and Brief Intervention

Outcome Measures

Primary Outcomes (1)

• Rate of harmful alcohol consumption (HAC)

  Rate of use and adherence to the SBI in preson and in electronic arm - defined as the proportion of participants randomized who complete all SBI or e-SBI components.

  6 months

Secondary Outcomes (2)

• adherence to the electronic SBI

  6 months

• amount of alcohol use

  6 months

Study Arms (2)

traditional in-person SBI - Control

ACTIVE COMPARATOR

in person screening and brief intervention tool (SBI) for reduce the rate of harmful alcohol consumption (HAC)

Behavioral: screening and brief intervention

electronic screening and brief intervention tool (e-SBI)

EXPERIMENTAL

electronic screening and brief intervention tool (e-SBI) to reduce the rate of harmful alcohol consumption (HAC)

Behavioral: electronic screening and brief intervention tool (e-SBI) for reducing rate of harmful alcohol consumption (HAC)

Interventions

screening and brief intervention BEHAVIORAL

tradicional in person screening and brief intervention for reducing the rate of harmful alcohol consumption (HAC)

traditional in-person SBI - Control

electronic screening and brief intervention tool (e-SBI) for reducing rate of harmful alcohol consumption (HAC) BEHAVIORAL

fully automated electronic screening and brief intervention tool (e-SBI) for reducing rate of harmful alcohol consumption (HAC)

electronic screening and brief intervention tool (e-SBI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• agree to participate in the study by signing the informed consent form and be over 18 years of age

You may not qualify if:

• Not agreeing to participate in the study and being under 18 years of age.

Sponsors & Collaborators

• InCor Heart Institute: lead

Study Sites (1)

Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (12)

• Centers for Disease Control and Prevention. Planning and Implementing Screening and Brief Intervention for Risky Alcohol Use: A Step-by-Step Guide for Primary Care Practices. Atlanta, GA: Centers for Disease Control and Prevention, National Center on Birth Defects and Developmental Disabilities; 2014

  BACKGROUND

• 3. World Health Organization (WHO). SAFER Initiative. Available at: https://www.who.int/initiatives/SAFER. Accessed September 5, 2022

  BACKGROUND

• 1. National Institute on Alcohol Abuse and Alcoholism (NIAAA). What Is a Standard Drink? Available at: https://www.niaaa.nih.gov/alcohols-effects-health/overview-alcohol-consumption/what-standard-drink. Accessed September 5, 2022.

  BACKGROUND

• Torres VN, Williams EC, Ceballos RM, Donovan DM, Ornelas IJ. Participant Satisfaction and Acceptability of a Culturally Adapted Brief Intervention to Reduce Unhealthy Alcohol Use Among Latino Immigrant Men. Am J Mens Health. 2020 May-Jun;14(3):1557988320925652. doi: 10.1177/1557988320925652.

  PMID: 32602803 RESULT

• Brown JL, Anastasakis I, Revzina N, Capasso A, Boeva E, Rassokhin V, Crusey A, Sales JM, Hitch A, Renfro T, DiClemente RJ. Development and Cultural Adaptation of a Computer-Delivered and Multi-Component Alcohol Reduction Intervention for Russian Women Living with HIV and HCV. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211044920. doi: 10.1177/23259582211044920.

  PMID: 34668412 RESULT

• Baldin YC, Sanudo A, Sanchez ZM. Effectiveness of a web-based intervention in reducing binge drinking among nightclub patrons. Rev Saude Publica. 2018;52:2. doi: 10.11606/s1518-8787.2018052000281. Epub 2018 Jan 18.

  PMID: 29364357 RESULT

• Bertholet N, Cunningham JA, Adam A, McNeely J, Daeppen JB. Electronic screening and brief intervention for unhealthy alcohol use in primary care waiting rooms - A pilot project. Subst Abus. 2020;41(3):347-355. doi: 10.1080/08897077.2019.1635963. Epub 2019 Jul 31.

  PMID: 31364948 RESULT

• Tansil KA, Esser MB, Sandhu P, Reynolds JA, Elder RW, Williamson RS, Chattopadhyay SK, Bohm MK, Brewer RD, McKnight-Eily LR, Hungerford DW, Toomey TL, Hingson RW, Fielding JE; Community Preventive Services Task Force. Alcohol Electronic Screening and Brief Intervention: A Community Guide Systematic Review. Am J Prev Med. 2016 Nov;51(5):801-811. doi: 10.1016/j.amepre.2016.04.013.

  PMID: 27745678 RESULT

• Barbosa C, McKnight-Eily LR, Grosse SD, Bray J. Alcohol screening and brief intervention in emergency departments: Review of the impact on healthcare costs and utilization. J Subst Abuse Treat. 2020 Oct;117:108096. doi: 10.1016/j.jsat.2020.108096. Epub 2020 Aug 4.

  PMID: 32811624 RESULT

• Enders CE, Staudt A, Freyer-Adam J, Meyer C, Ulbricht S, John U, Baumann S. Brief alcohol intervention at a municipal registry office: reach and retention. Eur J Public Health. 2021 Apr 24;31(2):418-423. doi: 10.1093/eurpub/ckaa195.

  PMID: 33152067 RESULT

• Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.

  PMID: 8329970 RESULT

• 2. Martinelli-Filho M, Spaggiari CV, Baroni RV, Gomes CIG, Hueb TO, Martins SAM, Pedrosa AAA, Nishioka SAD, Siqueira SF. Harmful Alcohol Consumption in Patients with Heart Disease: A Risk Analysis by Lifestyle Behavior - The Brazilian PROSA Project (Projeto Saúde e Álcool). Arq. Bras. Cardiol. 122 (10) Oct 2025 https://doi.org/10.36660/abc.20240744i

  RESULT

Related Links

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Arquivos Brasileiros de Cardiologia
• SAFER Initiative

MeSH Terms

Conditions

Binge Drinking

Interventions

Crisis Intervention; Ethanol; Economics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Alcohols; Organic Chemicals; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center, open-label, parallel-group, randomized controlled trial comparing an electronic SBI (e-SBI) delivered via a WhatsApp-based chatbot with a traditional in-person SBI.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 30, 2026
• Study Start: February 15, 2024
• Primary Completion: February 8, 2025
• Study Completion: December 15, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

BR (1)