| CTRI Number |
CTRI/2025/06/089460 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Two Methods of Helping Drivers in Patna Quit Smoking. |
|
Scientific Title of Study
|
Effectiveness of Cognitive Behavioral Therapy compared with Basic health education for tobacco cessation among 35-44 years smoker drivers at Government Bus stand, Patna: A randomized 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 |
Dr Gagan Raj |
| Designation |
Research scholar |
| Affiliation |
Teerthanker Mahaveer Dental college and Research Centre |
| Address |
Department of Public Health Dentistry,2nd floor, Teerthanker Mahaveer Dental college and Research centre, NH 9 , Delhi road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8084375547 |
| Fax |
|
| Email |
dr.graj2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Jain |
| Designation |
Professor & Vice Principal |
| Affiliation |
Teerthanker Mahaveer Dental college and Research Centre |
| Address |
Department of Public Health Dentistry,2nd floor, Teerthanker Mahaveer Dental college and Research centre, NH 9 , Delhi road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7906476348 |
| Fax |
|
| Email |
ankitajain.0815@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gagan Raj |
| Designation |
Research scholar |
| Affiliation |
Teerthanker Mahaveer Dental college and Research Centre |
| Address |
Department of public health dentistry, Teerthanker Mahaveer Dental college and Research centre, NH 9 , Road , Moradabad, Uttar pradesh 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8084375547 |
| Fax |
|
| Email |
dr.graj2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry,2nd floor, Teerthanker Mahaveer Dental college and Research centre, NH 9 , Delhi road, Moradabad, Uttar pradesh, India, pin- 244001 |
|
|
Primary Sponsor
|
| Name |
Dr Gagan Raj |
| Address |
Department of Public Health Dentistry,2nd floor, Teerthanker Mahaveer Dental college and Research centre, NH 9 , Delhi road, Moradabad, UP ,244001, India |
| Type of Sponsor |
Other [Private dental college] |
|
|
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 |
| Dr Ankita Jain |
Teerthanker Mahaveer dental college and research centre |
Department of public health dentistry,NH 9 , Delhi Road , Moradabad, Uttar pradesh 244001
Moradabad
UTTAR PRADESH |
07906476348
ankitajain.0815@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Teerthanker Mahaveer dental college and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Current Tobacco smokers aged 35-44 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Basic health education |
Educational sessions providing information on health hazards of smoking and benefits of quitting. Conducted weekly over 12 weeks in 6 sessions. tOTAL TIME DURATION WILL BE AROUND 1 YEAR FO (each 60 minutes), using pamphlets, videos, and motivational talks. Sessions aim to increase awareness and promote positive behavioral change regarding smoking.Total duration will be around 1 year |
| Intervention |
Cognitive Behavioral Therapy |
Structured therapy sessions aimed at changing smoking-related behaviors and thoughts, conducted over a period of 12 weeks with weekly 1-hour sessions.Total duration for this intervention will be around 1 year |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Male |
| Details |
Participants who remained current smokers , who respond to the questionnaire and give consent will be enrolled.
|
|
| ExclusionCriteria |
| Details |
Participant who uses smokeless form of tobacco
Previous history of alcohol and/or illegitimate drug abuse in the past 12 months
Participants who received tobacco cessation counseling previously.
Participants under nicotine replacement therapy (NRT)
Participants who will not give consent or are uncooperative |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Tobacco abstinence confirmed through a combination of self-reported cessation through TTM Questionnaire and objective validation using exhaled carbon monoxide (CO) levels measured by the Bedfont R Scientific EC50 Micro-III Smoke analyzer.
|
Baseline, 4 weeks, and 12 weeks post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in nicotine dependence levels as measured by the Fagerström Test for Nicotine Dependence (FTND) score. |
Baseline, 4 weeks, and 12 weeks post-intervention. |
| Stage progression in the Transtheoretical Model (TTM) – e.g., from pre-contemplation to maintenance. |
Baseline, 4 weeks, and 12 weeks post-intervention. |
| Improvement in self-efficacy and reduction in temptation to smoke, assessed using validated TTM scales. |
Baseline, 4 weeks, and 12 weeks post-intervention. |
| Change in decisional balance scores (pros vs. cons of smoking). |
Baseline, 4 weeks, and 12 weeks post-intervention. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a single blind two arm randomized controlled trial designed to evaluate the effectiveness of CBT compared with BHE for tobacco cessation among government bus drivers aged 35-44 years at government bus stand, patna. A total of 200 participants 100 in each group will be randomly allocated using simple randomization. The primary outcome will be tobacco abstinence confirmed by self report and exhaled CO levels. Secondary outcomes will be seen using transtheoretical model based questionnaire. Follow up will be conducted at 4 and 12 weeks. |