Efficacy of AI based Conversational chatbot as an adjuvant to conventional Psycotherapy in Tobacco cessation among Tobacco users-A Randomised Control Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Changes in the salivary cotinine levels and nicotine dependence level among tobacco users at baseline and 2 month intervals
研究概览
简要总结
Aim To determine the efficacy of an AI-based conversational chatbot as an adjuvant to
conventional psychotherapy in tobacco cessation among tobacco users
OBJECTIVES
1 To estimate the salivary cotinine levels among tobacco users before and after
psychotherapy
2 To estimate the salivary cotinine level among tobacco users after adjuvant AI-based
conversational chatbot
3 To correlate/compare the salivary cotinine levels in tobacco users who have received
only psychotherapy Vs those who received adjuvant AI-based conversational
chatbot
RESEARCH QUESTION Is there any alteration in the salivary cotinine levels of
participants in the psychotherapy group vs AI-based conversational chatbot at baseline and
at a 2-month interval
POPULATIONS Tobacco users
INTERVENTION AI-based conversational chatbot
COMPARISON Salivary cotinine levels of the participants in the psychotherapy group
and intervention group
OUTCOME Change in the salivary cotinine levels and nicotine dependence level
among tobacco users at baseline and 2-month intervals
The study includes two groups of tobacco users Group A will receive conventional psychotherapy while Group B will receive psychotherapy along with the AI chatbot intervention Salivary cotinine levels will be measured at baseline and at a 2 month interval to assess biochemical changes in nicotine exposure. The primary outcome is the change in salivary cotinine levels between the two groups Based on previous studies (mean IS 12.32 SD is 7.5), with alpha is 0.05 and a precision of 3 the sample size was calculated using Cochran s formula yielding 24 participants per group After adjusting for a 10% dropout rate the final sample size is 27 per group totaling 54 participants the patients will be followed for 2 months and post cotinine levels will be taken
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Day(s) 至 60.00 Day(s)(—)
- 性别
- Male
入选标准
- •Smokers under the category of Karl-Olov Fgerstorm-low and medium dependent smokers .Male subjects from 19 to 60 yrs.
排除标准
- •smokers under the category of Karl-Olov Fgerstorm-high dependent smokers subjects who don t have smartphones subject who consume smokeless tobacco.
结局指标
主要结局
Changes in the salivary cotinine levels and nicotine dependence level among tobacco users at baseline and 2 month intervals
时间窗: 2 months
次要结局
未报告次要终点
研究者
Aishwaryaa B
Indira Gandhi I nstitute of Dental Sciences ,SBV
