Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602882
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Chatbot-delivered Screening and Brief Intervention for Alcohol Reduction in Working-age Adults
Sponsor:
None
Organization:
None
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alcohol abuse led to 53 of all deaths and 51 of all disability-adjusted life years globally in 2016 representing a heavier public health burden than diabetes tuberculosis or HIVAIDS 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
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 gramsweek 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
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 gramsweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None