CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/03/082500 [Registered on: 17/03/2025] Trial Registered Prospectively

Last Modified On:

10/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Behavioral

Study Design

Single Arm Study

Public Title of Study

Understanding smoking usage through a single session of motivational interviewing in young adults.

Scientific Title of Study

Effectiveness of Single Session Motivational Interviewing on Stages of Change for Smoking Cessation in Young Adults

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Khushi Majithiya
Designation	Clinical Psychology Trainee
Affiliation	Rashtriya Raksha University
Address	Department of Clinical Psychology, School of Behavioural Sciences and Forensic Investigations, Rashtriya Raksha University, At. Lavad, Ta. Dehgam, Gandhinagar Gandhinagar GUJARAT 382305 India
Phone	6353177474
Fax
Email	khushimajithiya7701@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Prachi Sanghvi
Designation	Assistant Professor (Clinical Psychologist)
Affiliation	Rashtriya Raksha University
Address	Department of Clinical Psychology, School of Behavioural Sciences and Forensic Investigations, Rashtriya Raksha University, At. Lavad, Ta. Dehgam, Gandhinagar Gandhinagar GUJARAT 382305 India
Phone	9429024840
Fax
Email	sanghviprachi@hotmail.com

Details of Contact Person
Public Query

Name	Khushi Majithiya
Designation	Trainee Clinical Psychologist
Affiliation	Rashtriya Raksha University
Address	Department of Clinical Psychology, School of Behavioural Sciences and Forensic Investigations, Rashtriya Raksha University, At. Lavad, Ta. Dehgam, Gandhinagar Gandhinagar GUJARAT 382305 India
Phone
Fax
Email	khushimajithiya7701@gmail.com

Source of Monetary or Material Support

Rashtriya Raksha University

Primary Sponsor

Name	Khushi Majithiya
Address	Rashtriya Raksha University, Lavad, Gandhinagar, 382305
Type of Sponsor	Other [Self ]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Khushi Majithiya	Rashtriya Raksha University	Department of Clinical Psychology, School of Behavioral Sciences and Forensic Investigations, Lavad, Gandhinagar Ahmadabad GUJARAT	6353177474 khushimajithiya7701@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Rashtriya Raksha University Ethics Commitee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	cigarette smoking in the last three months

Intervention / Comparator Agent

Type	Name	Details
Intervention	Motivational Interviewing	Motivational Interviewing was first described by William R. Miller and Stephen Rollnick (Miller & Rollnick, 2002). It is an evidence based and a client-centered counseling technique which promotes change addressing the ambivalence of a particular behavior (Motivational Interviewing Network of Traniers, 2019). In the past, MI has been found to be helpful for promoting health-related behavior changes and better adherence to the treatment (Bischof et al., 2021).
Comparator Agent	Not Applicable	Not Applicable

Inclusion Criteria

Age From	18.00 Year(s)
Age To	35.00 Year(s)
Gender	Both
Details	People who smoke tobacco cigarettes in the community setting Working knowledge of English, Hindi or Gujarati All Genders

ExclusionCriteria

Details

Any diagnosed psychiatric condition with active symptoms that may interfere with the study participation.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Stages of Change	Baseline, Post Intervention and at One month follow up.

Secondary Outcome

Outcome	TimePoints
Cigarette Smoking Use	Baseline and at one month follow-up.

Target Sample Size

Total Sample Size="28"
Sample Size from India="28"
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)

28/03/2025

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="0"
Months="7"
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

There is a significant treatment gap (91.8%) for tobacco use in India (National Mental Health Survey, 2016). Brief interventions like motivational interviewing (MI) could be particularly effective for smoking cessation in the Indian context. Thus the aim of this study is to study the effectiveness of single-session motivational interviewing on stages of change for smoking cessation among young adults. Using a pre-post without control group design, 28 participants will be recruited through purposive and snowball sampling. Readiness to change and smoking behavior will be assessed using the ASSIST and URICA tools, with follow-up evaluations conducted one-month post-intervention. By addressing the significant treatment gap for tobacco use in India, the study aims to provide evidence for scalable, culturally relevant interventions to support smoking cessation in young adults.