- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06570070
AI-powered Chatbot vs. Human Counselors in Smoking Cessation
Effectiveness of Artificial Intelligence (AI)-Powered Chatbot vs. Human Counselors in Smoking Cessation
Study Overview
Status
Conditions
Detailed Description
Smoking cessation remains one of the most significant public health challenges worldwide, with tobacco use being a leading cause of preventable death and disease. Despite extensive efforts, the success rates of smoking cessation programs remain low, necessitating innovative approaches to support individuals in their journey to quit smoking. Recently, artificial intelligence (AI) has opened new possibilities in healthcare, including the development of AI-powered chatbots that assist individuals in behavior change, such as quitting smoking.
This randomized controlled trial aims to investigate the effectiveness of AI-powered chatbot that simulates human counselors, compared to traditional human counseling in promoting smoking cessation among community smokers. The AI-powered chatbot, equipped with personalized interactions and real-time support, offers scalable and cost-effective assistance, potentially making it an accessible alternative to human counseling. However, human counselors provide empathy, tailored advice, and a nuanced understanding of human behavior that AI may not fully replicate. This study will explore which approach is more effective in helping individuals achieve long-term smoking cessation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xue Weng
- Phone Number: 3621259
- Email: xueweng@bnu.edu.cn
Study Locations
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Guangdong
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Zhuhai, Guangdong, China, 519087
- Beijing Normal University
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Contact:
- Xue Weng
- Email: xueweng@bnu.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 18 and above, reside in Zhuhai for the next 6 months;
- smoke at least 1 cigarette or use e-cigarettes daily;
- Having a smartphone and a WeChat account, being able to use WeChat skillfully.
Exclusion Criteria:
- Smokers who have communication barrier (either physically or cognitively);
- Smokers who are currently participating in other SC programmes or services
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI support group
AI-powered chatbot support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
|
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
Participants will receive three months of AI-powered chatbot, equipped with personalized interactions and real-time support, via WeChat.
|
|
Experimental: Counselor support group
Counselor individual support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
|
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
Participants will receive three months of counselor-led individual support via WeChat.
The regular messages and instant messaging on psychosocial support aim to provide cessation advice, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.
|
|
Active Comparator: Control group
5A's/5R's advice + health warning leaflet+ Self-help booklet
|
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemical validated quit rate at 6 months follow-up
Time Frame: 6 months follow-up
|
The primary outcomes are biochemically validated quit rate (exhaled carbon monoxide < 4 ppm or salivary cotinine < 30 ng/ml)
|
6 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported 7-day point prevalence quit rate
Time Frame: 3 and 6 months follow-up
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Self-reported 7-day point prevalence quit rate in the two groups
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3 and 6 months follow-up
|
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Smoking reduction rate
Time Frame: 3 and 6 months follow-up
|
Rate of smoking reduction by at least half of baseline amount in the two groups
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3 and 6 months follow-up
|
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Eligibility rate
Time Frame: baseline
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the percentage of eligible smokers out of the total number of smokers screened
|
baseline
|
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Consent rate
Time Frame: baseline
|
the percentage of eligible smokers who agree to participate out of the total number of eligible smokers
|
baseline
|
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Percentage of Participant Engagement with E-Messages and Counselor Chats
Time Frame: 3 months follow-up
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This outcome measures the percentage of participants who engage with the intervention by reading e-messages and responding to counselor chat messages at least once during the 3-month follow-up period.
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3 months follow-up
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Biochemical validated quit rate at 3 months follow-up
Time Frame: 3 months follow-up
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biochemically validated quit rate (exhaled carbon monoxide < 4 ppm or salivary cotinine < 30 ng/ml)
|
3 months follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AI-powered cessation support
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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