AI-powered Chatbot vs. Human Counselors in Smoking Cessation

Not Applicable

Not yet recruiting

• Conditions: Smoking Cessation; Mobile Health
• Interventions: Behavioral: 5A's/5R's advice; Other: Brief leaflet on health warning and smoking cessation; Other: Self-help smoking cessation booklet; Behavioral: AI-powered chatbot support; Behavioral: Counselor individual support

• Registration Number: NCT06570070
• Lead Sponsor: Beijing Normal University

Brief Summary

This study aims to explore the feasibility and preliminary effectiveness of AI-powered chatbot support in community smokers.

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Study Start: 2024-09-01
• Primary Completion: 2025-06-20
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. aged 18 and above, reside in Zhuhai for the next 6 months;
2. smoke at least 1 cigarette or use e-cigarettes daily;
3. Having a smartphone and a WeChat account, being able to use WeChat skillfully.

Exclusion Criteria

1. Smokers who have communication barrier (either physically or cognitively);
2. Smokers who are currently participating in other SC programmes or services

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI support group	5A's/5R's advice	AI-powered chatbot support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
Control group	5A's/5R's advice	5A's/5R's advice + health warning leaflet+ Self-help booklet
Counselor support group	Brief leaflet on health warning and smoking cessation	Counselor individual support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
AI support group	AI-powered chatbot support	AI-powered chatbot support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
Counselor support group	Self-help smoking cessation booklet	Counselor individual support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
Counselor support group	Counselor individual support	Counselor individual support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
Counselor support group	5A's/5R's advice	Counselor individual support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
AI support group	Brief leaflet on health warning and smoking cessation	AI-powered chatbot support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
AI support group	Self-help smoking cessation booklet	AI-powered chatbot support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet
Control group	Brief leaflet on health warning and smoking cessation	5A's/5R's advice + health warning leaflet+ Self-help booklet
Control group	Self-help smoking cessation booklet	5A's/5R's advice + health warning leaflet+ Self-help booklet

Primary Outcome Measures

Name	Time	Method
Biochemical validated quit rate at 6 months follow-up	6 months follow-up	The primary outcomes are biochemically validated quit rate (exhaled carbon monoxide \< 4 ppm or salivary cotinine \< 30 ng/ml)

Secondary Outcome Measures

Name	Time	Method
Self-reported 7-day point prevalence quit rate	3 and 6 months follow-up	Self-reported 7-day point prevalence quit rate in the two groups
Biochemical validated quit rate at 3 months follow-up	3 months follow-up	biochemically validated quit rate (exhaled carbon monoxide \< 4 ppm or salivary cotinine \< 30 ng/ml)
Consent rate	baseline	the percentage of eligible smokers who agree to participate out of the total number of eligible smokers
Smoking reduction rate	3 and 6 months follow-up	Rate of smoking reduction by at least half of baseline amount in the two groups
Eligibility rate	baseline	the percentage of eligible smokers out of the total number of smokers screened
Percentage of Participant Engagement with E-Messages and Counselor Chats	3 months follow-up	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.

Trial Locations

Locations (1)

Beijing Normal University; 🇨🇳 Zhuhai, Guangdong, China