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临床试验/CTRI/2025/04/085142
CTRI/2025/04/085142尚未招募1/2 期

Efficacy of AI based Conversational chatbot as an adjuvant to conventional Psycotherapy in Tobacco cessation among Tobacco users-A Randomised Control Trial

Aishwaryaa1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年5月11日最近更新:

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

发起方
Aishwaryaa
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Aishwaryaa B

Indira Gandhi I nstitute of Dental Sciences ,SBV

研究点 (1)

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