| CTRI Number |
CTRI/2025/04/085142 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the Effectiveness of an AI Conversational Chatbot as a Supportive Tool for Psychotherapy in Tobacco Cessation |
|
Scientific Title of Study
|
Efficacy of AI based Conversational chatbot as an adjuvant to conventional Psycotherapy in Tobacco cessation among Tobacco users-A Randomised Control Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwaryaa B |
| Designation |
Postgraduate |
| Affiliation |
Indira Gandhi I nstitute of Dental Sciences ,SBV |
| Address |
Pondicherry cuddalore road Pillayarkuppam Pondicherry,607402
Pondicherry cuddalore road Pillayarkuppam Pondicherry,607402
Pondicherry
PONDICHERRY
605001
India |
| Phone |
7339156839 |
| Fax |
|
| Email |
aish1998balamouraly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aishwaryaa B |
| Designation |
Postgraduate |
| Affiliation |
Indira Gandhi I nstitute of Dental Sciences ,SBV |
| Address |
Pondicherry cuddalore road Pillayarkuppam Pondicherry,607402
Pondicherry cuddalore road Pillayarkuppam Pondicherry,607402
Pondicherry
PONDICHERRY
605001
India |
| Phone |
7339156839 |
| Fax |
|
| Email |
aish1998balamouraly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwaryaa B |
| Designation |
Postgraduate |
| Affiliation |
Indira Gandhi I nstitute of Dental Sciences ,SBV |
| Address |
Pondicherry cuddalore road Pillayarkuppam Pondicherry,607402
Pondicherry cuddalore road Pillayarkuppam Pondicherry,607402
Pondicherry
PONDICHERRY
605001
India |
| Phone |
7339156839 |
| Fax |
|
| Email |
aish1998balamouraly@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aishwaryaa |
| Address |
No 49 A Eswaran koil street,Pondicherry ,605001 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aishwaryaa B |
Indira Gandhi institute of dental sciences,SBV |
pillayarkuppam po ndicherry
Pondicherry
PONDICHERRY |
7339156839
aish1998balamouraly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
volunteers who are smokers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
chatbot |
the chatbot is developed with chatgpt as backend |
| Comparator Agent |
pschyotherapy |
It will be given by trained psychologist |
|
|
Inclusion Criteria
|
| Age From |
19.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Male |
| Details |
Smokers under the category of Karl-Olov Fgerstorm-low and medium dependent smokers .Male subjects from 19 to 60 yrs |
|
| ExclusionCriteria |
| Details |
smokers under the category of Karl-Olov Fgerstorm-high dependent smokers subjects who don t have smartphones subject who consume smokeless tobacco
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the salivary cotinine levels and nicotine dependence level among tobacco users at baseline and 2 month intervals |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
11/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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
|