Excessive Alcohol ConsumptionNCT06602882
Chatbot-delivered Screening and Brief Intervention for Alcohol Reduction in Working-age Adults
A study testing chatbot-delivered screening and brief intervention in people with Excessive Alcohol Consumption, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Excessive Alcohol Consumption
- What is being tested?
- chatbot-delivered screening and brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-59 years
- being employed in the past 12 months
- a modified Alcohol Use Disorders Identification Test (AUDIT-C) score ≥3
- having a smartphone with internet access
- able to communicate in Chinese
Who cannot join
- mentally and/or
- physically unable to complete the intervention and/or the two follow-ups
- undergoing any alcohol-related intervention
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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).
- To evaluate the SBI chatbot in reducing alcohol-related harm risk measured by AUDIT scores over 4 week in at-risk working-age adults.
- To assess the usability of the SBI chatbot by at-risk working-age adults.
- 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.
- Conditions
- Excessive Alcohol Consumption
- Being tested
- chatbot-delivered screening and brief intervention
- Keywords
- adults, Chatbot, excessive alcohol consumption, screening and brief intervention, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chatbot-delivered screening and brief interventionBehavioural
- Screening and personalised advice based on AUDIT-C scores, personal reasons for drinking, and specific barriers: For a score of ≥ 3, the participant will be reminded of the level of risks and dangers of alcohol consumption and the benefits of consumption reduction/cessation and will be assessed for the personal reasons for drinking and specific barriers.
- Warning of alcohol and alcohol-related harms and reminding of benefits of reduced consumption: The Department of Health's health warning booklet, which has been designed by two of our Co-Is, will be used as the educational content.
- Realistic and personal goals setting: A specific and measurable goal will be set for the upcoming week. For example, "I will reduce to 1 bottle of beer in the upcoming week.
- Motivational enhancement and practical coping strategies: Tangible advice will be given for coping with situational barriers according to their personal reasons for drinking.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will engage with a chatbot-delivered screening and brief intervention (SBI) over a 30-minute period on the chatbot webpage.
The SBI chatbot involves screening individuals for alcohol consumption by AUDIT before recruitment and then providing a brief intervention comprising personalised feedback. Its delivery is fully automated via a smartphone app. Receives: Behavioral: chatbot-delivered screening and brief intervention |
| Waitlist control group | Experimental | All participants in the waitlist control will receive the SBI chatbot 4 weeks later. The intervention has the same content for both intervention and waitlist control groups. Receives: Behavioral: chatbot-delivered screening and brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption in grams per week
The primary outcome is the amount of alcohol consumed per week (grams/week) at the 4-week follow-up, which is recommended as the gold standard for determining effectiveness in many alcohol trials. The data collected for computing the alcohol consumption comprise type of alcohol (e.g. wine, beer, liquor, etc.) and units (e.g. 1 glass of 250ml, 1 can of 330 ml, etc.) consumed in the past week, which will be computed according to a formula with standard alcohol (unit per week) x 10 gram.
Measured: 4-week follow-up
Secondary outcomes (3)
AUDIT scores
AUDIT has 10 items and the total scores range from 0 to 40. Scores of 1 to 7 suggest low-risk alcohol consumption, 8 to 15 suggest hazardous or harmful alcohol.
Measured: 4-week follow-up
The 15-item Bot Usability Scale
It was designed to evaluate chatbot usability in 5 domains: perceived accessibility to the chatbot function, perceived quality of chatbot functions, perceived quality of conversation and information provided, perceived privacy and security, and time response. Participants will rate each item on a 5-point Likert scale (1=strongly disagree to 5=strongly agree).
Measured: 4-week follow-up
Economic evaluation
An EQ-5D-5L utility score will be estimated using the Hong Kong EQ-5D-5L value set. The EQ-5D-5L is a 25-item self-reported health questionnaire plus a visual analogue scale to describe how good or bad your health is today.
Measured: 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wang Man-Ping, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602882
- Sponsor's protocol ID
- Alcohol chatbot for adults
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06602882
- Acronym / sponsor ID
- Alcohol chatbot for adults
- Conditions
- Excessive Alcohol Consumption
- Keywords
- adults, Chatbot, excessive alcohol consumption, screening and brief intervention, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
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:
- 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).
- To evaluate the SBI chatbot in reducing alcohol-related harm risk measured by AUDIT scores over 4 week in at-risk working-age adults.
- To assess the usability of the SBI chatbot by at-risk working-age adults.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: chatbot-delivered screening and brief interventionParticipants in the intervention group will engage with a chatbot-delivered screening and brief intervention (SBI) over a 30-minute period on the chatbot webpage. The SBI chatbot involves screening individuals for alcohol consumption by AUDIT before recruitment and then providing a brief intervention comprising personalised feedback. Its delivery is fully automated via a smartphone app. |
| Waitlist control group | Experimental | Behavioral: chatbot-delivered screening and brief interventionAll participants in the waitlist control will receive the SBI chatbot 4 weeks later. The intervention has the same content for both intervention and waitlist control groups. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18-59 years
- being employed in the past 12 months
- a modified Alcohol Use Disorders Identification Test (AUDIT-C) score ≥3
- having a smartphone with internet access
- able to communicate in Chinese
Key exclusion criteria (3 listed)
- mentally and/or
- physically unable to complete the intervention and/or the two follow-ups
- undergoing any alcohol-related intervention
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 |
|---|---|---|
| chatbot-delivered screening and brief intervention1. Screening and personalised advice based on AUDIT-C scores, personal reasons for drinking, and specific barriers: For a score of ≥ 3, the participant will be reminded of the level of risks and dangers of alcohol consumption and the benefits of consumption reduction/cessation and will be assessed for the personal reasons for drinking and specific barriers. 2. Warning of alcohol and alcohol-related harms and reminding of benefits of reduced consumption: The Department of Health's health warning booklet, which has been designed by two of our Co-Is, will be used as the educational content. 3. Realistic and personal goals setting: A specific and measurable goal will be set for the upcoming week. For example, "I will reduce to 1 bottle of beer in the upcoming week. 4. Motivational enhancement and practical coping strategies: Tangible advice will be given for coping with situational barriers according to their personal reasons for drinking. | Behavioural | Intervention group, Waitlist control group |
Primary outcome
Alcohol consumption in grams per week
Time frame: 4-week follow-up
The primary outcome is the amount of alcohol consumed per week (grams/week) at the 4-week follow-up, which is recommended as the gold standard for determining effectiveness in many alcohol trials. The data collected for computing the alcohol consumption comprise type of alcohol (e.g. wine, beer, liquor, etc.) and units (e.g. 1 glass of 250ml, 1 can of 330 ml, etc.) consumed in the past week, which will be computed according to a formula with standard alcohol (unit per week) x 10 gram.
3 secondary outcomes
AUDIT scores
Time frame: 4-week follow-up
The 15-item Bot Usability Scale
Time frame: 4-week follow-up
Economic evaluation
Time frame: 4-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chatbot-delivered screening and brief intervention in people with Excessive Alcohol Consumption, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption in grams per week (time frame: 4-week follow-up). 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 19 Sep 2024.