NCT07577167

Brief Summary

The goal of this clinical trial is to learn if a Modified Motivational Interviewing (MMI) program can help university students quit smoking. The main questions it aims to answer are: Does the MMI program reduce physical nicotine dependence and increase motivation to quit smoking. Does the MMI program improve students' confidence and perceived importance regarding quitting smoking. Researchers will compare a group receiving the MMI intervention to a control group (who receive no initial intervention) to see if the video-based program is an effective and cost-saving way to treat smoking behavior. Participants will: Complete self-report surveys about their smoking habits and feelings toward quitting at the start of the study, after 8 weeks, and 3 months later. Record two 15-minute videos per week for the first 2 weeks using a mobile phone or similar device. Record one 15-minute video per week for the next 2 weeks. Record one 15-minute video every 2 weeks for the final 4 weeks. Receive individualized feedback from researchers on the content of their videos to help guide their "change talk".Have the option to share their videos with other students in the program through a private, virtual online thread.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

April 20, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

Modified Motivational InterviewingSmoking CessationMotivational Interviewing

Outcome Measures

Primary Outcomes (3)

  • Physical Dependence on Nicotine

    Fagerstrom Test for Nicotine Dependence (FTND): A 6-item scale resulting in a total score of 0-10, used to categorize dependence from "very low" to "high". with the higher score indicating more nicotine dependency

    Baseline, Post-intervention (8 weeks), and 3-month follow-up.

  • Readiness to Quit Smoking

    Readiness to change Questionnaire Treatment version (RCQ-TV): A 10-point visual analog scale (1 to 10) where higher scores indicate a greater readiness to consider or maintain smoking cessation.

    Baseline, Post-intervention (8 weeks), and 3-month follow-up.

  • Motivation to Quit Smoking

    Smoking Cessation Motivation (QMAT): A 6-item instrument measuring self-efficacy for smoking cessation on a scale of 0 to 24; higher scores indicate higher motivation and self-efficacy.

    Baseline, Post-intervention (8 weeks), and 3-month follow-up.

Secondary Outcomes (3)

  • Reinforcing and Aversive Effects of Smoking

    Baseline, Post-intervention (8 weeks), and 3-month follow-up.

  • Importance of Quitting Smoking

    Baseline, Post-intervention (8 weeks), and 3-month follow-up.

  • Confidence in Quitting Smoking

    Baseline, Post-intervention (8 weeks), and 3-month follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants who receive the Modified Motivational Interviewing

Behavioral: Modified Motivational Interviewing

Control Group

NO INTERVENTION

Participants who receive no intervention during the active study period but are monitored simultaneously with the intervention group.

Interventions

The Modified Motivational Interviewing (MMI) intervention is a self-administered, video-based program that replaces traditional, costly practitioner-led counseling. Distinguishing Features: Participant-Led "Change Talk": Students record 15-minute videos on their mobile devices focusing on four categories: advantages of quitting, optimism for change, intention to change, and status quo disadvantages. Asynchronous Feedback: Researchers provide individualized content feedback, ensuring each video meets behavioral criteria before the next is recorded. Tapered Schedule: To foster independence, frequency decreases over 8 weeks: 2 videos/week (weeks 1-2), 1 video/week (weeks 3-4), and 1 video every 2 weeks (weeks 5-8).Peer Support: Includes an optional private virtual thread for participants to share videos with others in the intervention arm.

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Academic Enrollment: Must be an actively enrolled student at Jordan University of Science and Technology.
  • Active Smoking Status: Must be an active smoker.
  • Smoking History: Defined as a person who has smoked more than 100 cigarettes in their life and still currently smokes.

You may not qualify if:

  • Prior Intervention Experience: Having previous experience with Motivational Interviewing (MI).
  • Prior MMI Exposure: Having previous experience with Modified Motivational Interviewing (MMI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, 21110, Jordan

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The study is Open Label, meaning no parties are masked or blinded. Because the Modified Motivational Interviewing (MMI) intervention requires participants to actively record videos and researchers to provide specific content feedback, both groups must be fully aware of the treatment assignment. While no formal masking is employed, the research team has established protocols to manage data integrity: Independent Data Collection: A research assistant is accessible to handle participant questions and oversee data collection. Identifiable Data Security: Participant identities and their associated data are secured and restricted to the research team to maintain confidentiality. Standardized Instruments: The use of valid and reliable self-report measures (such as the MCEQ, SASEQ, and FTCD) helps ensure that outcomes are measured consistently across both the intervention and control groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The goal of this randomized controlled trial is to evaluate a Modified Motivational Interviewing (MMI) program for smoking cessation among university students. Traditional counseling is often costly and requires highly skilled practitioners. This study tests a self-implemented, video-based version designed to be cost-effective and flexible. Participants will: Complete surveys on nicotine dependence and motivation at three intervals: baseline, 8 weeks, and 3 months post-intervention. Record 15-minute videos focused on "change talk," including the advantages of quitting and intentions to change. Follow a tapering schedule: 2 videos/week for 2 weeks, 1 video/week for 2 weeks, then 1 video every 2 weeks for a month. Receive expert feedback on video content. Researchers will compare 103 intervention participants to 103 control participants to measure improvements in quitting confidence and readiness.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2026

First Posted

May 11, 2026

Study Start

May 1, 2025

Primary Completion

January 11, 2026

Study Completion

January 11, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

While the proposal does not explicitly state a plan to share IPD with external researchers, it outlines strict data security protocols that suggest access is restricted to the immediate study team: Restricted Access: The proposal states that identifiable data of the participants will be secured and only accessed by the research team. Safety Measures: Further measures will be taken to ensure the safety of participants' data, including the use of informed consent forms before the study begins. Institutional Ownership: According to the Intellectual Property Rights Form of Jordan University of Science and Technology, all research results and products are the property of the university. Confidentiality: Investigators and students are required to maintain full confidentiality regarding any inventions or discoveries resulting from the research.

Locations