| CTRI Number |
CTRI/2025/10/096576 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational] |
| Study Design |
Other |
|
Public Title of Study
|
Development, Validation, and Piloting of Brief
Educational Module on Harmful Consequences of
Nicotine Addiction |
|
Scientific Title of Study
|
Development, Validation, and Piloting of Brief
Educational Module on Harmful Consequences of
Nicotine Dependence |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKulkarni Kshitij |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Psychiatry Department KMC Hospital,Manipal, Karntaka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9653454901 |
| Fax |
|
| Email |
kulkarni.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSamir K Prahraj |
| Designation |
Professor, Department of Psychiatry |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Psychiatry Department KMC Hospital,Manipal, Karntaka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8971026304 |
| Fax |
|
| Email |
samir.kp@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrSamir K Prahraj |
| Designation |
Professor, Department of Psychiatry |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Psychiatry Department KMC Hospital,Manipal, Karntaka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8971026304 |
| Fax |
|
| Email |
samir.kp@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
DrKulkarni Kshitij |
| Address |
Department of psychiatry,KMC hospital Manipal,Karnataka,576104 |
| 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 |
| DrKulkarni Kshitij |
Kasturba Medical college Manipal udupi |
Room No.103, 3rd floor,Department of Psychiatry,Kasturba Medical College,Tiger Circle road, Madhav Nagar
Udupi
KARNATAKA |
9653454901
kulkarni.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief Psychoeducation session |
Participants will have a single 30-minute individual psychoeducation session, conducted using the
brief educational module that includes pictures and possibly videos
Frquency of Session -Only once for a pateint
Total duration of intervention- 30mins |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Inpatients with a diagnosis of nicotine dependence syndrome at KMC hospital.
2. Patients who can give written informed consent to participate in the study.
3. Patients of either gender and an age range of 18-60 years. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe medical conditions
2. Patients with acute symptomatic psychosis.
3. Non-cooperative patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Knowledge, Attitude, and Practice (KAP) Questionnaire – to assess change in participants’ knowledge, attitudes, and practices regarding the harmful effects of nicotine dependence before and after the educational intervention.
Content Validity Index (CVI) – to evaluate content validity of the educational module |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fagerström Test for Nicotine Dependence (FTND) – to assess the level of nicotine dependence.
Readiness to Change Questionnaire (RCQ) – to assess the participant’s motivational stage toward behavior change.
Readiness Ruler – to measure the participant’s perceived readiness to quit nicotine use.
Thoughts About Abstinence (TAA) Scale – to evaluate the participant’s desire, confidence, and commitment toward abstinence.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/11/2025 |
| 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="6"
Days="1" |
|
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
|
The study will be conducted in 3 phases In 1st phase the scoping review will be conducted using databases like PubMed with key terms such as Nicotine Tobacco and Psychoeducation to identify existing educational material Necessary institutional permissions will be taken to access both public and proprietary sources Existing educational materials on the consequences of nicotine addiction will be evaluated for accuracy relevance cultural suitability and effectiveness If suitable the material will be implemented otherwise a new module will be developed In 2nd phase Consensus based feedback will be collected from 5 to 10 subject experts via email to validate the module Experts will assess for accuracy and appropriateness and content validity will be evaluated using the Content Validity Index CVI Based on their feedback necessary refinements will be made A pilot study with five patients diagnosed with nicotine dependence syndrome selected on the basis of inclusion and exclusion criteria will be conducted to evaluate the draft module and gather feedback for improvement Patients with nicotine dependence syndrome will be recruited as per the ICD 11 criteria In 3rd phase the refined version will then be tested in a sample of 30 participants with NDS selected on the basis of inclusion and exclusion criteria to assess the efficacy and feasibility of the module Participants will have a single 30 minute individual psychoeducation session conducted using the brief educational module that includes pictures and possibly videos Fidelity measures will be used to ensure that nothing is missed during the implementation Assessment tools will be administered at three time points before the intervention baseline Semi structured proforma FTND KAP Questionnaire Readiness to Change Scale Readiness Ruler after the intervention immediately after the intervention KAP Questionnaire Readiness to Change Scale Readiness Ruler and one month post intervention in OPD If the patient doesnt follow up in OPD follow up will be via telephone KAP Questionnaire Readiness to Change Scale Readiness Ruler All patients participating in the study will continue to receive standard care from the treating team which includes assessments medications psychoeducation and other non pharmacological treatments The current intervention will be provided to one group of patients in addition to the standard care |