Clinical trial NCT06602882: Chatbot-delivered Screening and Brief Intervention for Alcohol Reduction in Working-age Adults
Official title: Effectiveness and Usability of a Chatbot-delivered Screening and Brief Intervention for Alcohol Reduction in Working-age Adults: A Proof-of-concept Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Excessive Alcohol Consumption
Keywords: adults
Chatbot
excessive alcohol consumption
screening and brief intervention
randomised controlled trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Alcohol abuse led to 5.3% of all deaths and 5.1% of all disability-adjusted life years globally in 2016, representing a heavier public health burden than diabetes, tuberculosis or HIV/AIDS (as documented in the World Health Organization (WHO) Global Status Report on Alcohol and Health). The increasing consumption of alcohol for a few decades has led to a higher risk of cirrhosis, cancers, hypertension, and cardiovascular and cerebrovascular diseases. Strengthening of the prevention and treatment of alcohol abuse has been incorporated in the Sustainable Development Goals (SDG3) by the United Nations.

Strong evidence from a meta-analysis demonstrated the efficacy of screening and brief intervention (SBI) in reducing weekly alcohol consumption. Although SBI is known to be effective in reducing alcohol consumption in at-risk drinkers, barriers to implementing SBI have been an issue. A systematic review identified that common barriers to the routine delivery of SBI by doctors and nurses included a lack of alcohol-related knowledge, time, confidence, ability, and incentive to intervene; worrying about offending patients; and SBI being an uncomfortable and frustrating task.

To scale up behavioural change interventions in primary care for expanding the scalability and reachability, artificial intelligence (AI) and AI-chatbots have been increasingly used in recent years. A systematic review showed that chatbots for mental health counselling were effective and safe. Other reviews also reported that chatbots might improve physical activity, diet, and weight management and oncology care. However, having searched PubMed and the Cochrane Library, there was no a randomised controlled trial on the use of an AI-chatbot for alcohol reduction.

Detailed description: Aim:

To adapt a self-developed SBI chatbot and conduct a proof-of-concept evaluation on its preliminary effectiveness and usability in reducing alcohol consumption after 4 weeks for at-risk working-age adults by using a randomised, open label, two-arm, parallel-group controlled trial.

Objectives of this project are:

1. To evaluate the SBI chatbot for its short-term effectiveness in reducing alcohol consumption in at-risk working-age adults over a 4-week period (primary outcome).
2. To evaluate the SBI chatbot in reducing alcohol-related harm risk measured by AUDIT scores over 4 week in at-risk working-age adults.
3. To assess the usability of the SBI chatbot by at-risk working-age adults.
4. To explore which factors are associated with, moderate, or mediate the effects of the SBI chatbot.

Hypotheses Hypothesis 1 (Primary outcome): Participants receiving chatbot-delivered SBI (intervention group) will have a higher reduction in weekly alcohol consumption (grams/week) than those in the waitlist control group at 4-week follow-up.

Hypothesis 2 (Secondary outcome): The intervention group will have a lower AUDIT score than the control group at 4-week follow-up.

Eligibility criteria: Inclusion Criteria:

1. aged 18-59 years
2. being employed in the past 12 months
3. a modified Alcohol Use Disorders Identification Test (AUDIT-C) score ≥3
4. having a smartphone with internet access
5. able to communicate in Chinese

Exclusion Criteria:

1. mentally and/or
2. physically unable to complete the intervention and/or the two follow-ups
3. undergoing any alcohol-related intervention

Primary outcomes:
measure: Alcohol consumption in grams per week
timeFrame: 4-week follow-up
Secondary outcomes:
measure: AUDIT scores
timeFrame: 4-week follow-up
measure: The 15-item Bot Usability Scale
timeFrame: 4-week follow-up
measure: Economic evaluation
timeFrame: 4-week follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing
state: Hong Kong Island
Study officials:
References: