- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07577167
Examining a Smoking Cessation Program: The Impact of a Modified Motivational Interviewing Consultation Approach
Examining a Smoking Cessation Program: The Impact of a Modified Motivational Interviewing Consultation Approach.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Irbid, Jordan, 21110
- Jordan University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Prior Intervention Experience: Having previous experience with Motivational Interviewing (MI).
Prior MMI Exposure: Having previous experience with Modified Motivational Interviewing (MMI).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
Participants who receive the Modified Motivational Interviewing
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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.
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No Intervention: Control Group
Participants who receive no intervention during the active study period but are monitored simultaneously with the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical Dependence on Nicotine
Time Frame: Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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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
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Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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Readiness to Quit Smoking
Time Frame: Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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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.
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Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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Motivation to Quit Smoking
Time Frame: Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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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.
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Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reinforcing and Aversive Effects of Smoking
Time Frame: Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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Modified Cigarette Evaluation Questionnaire (MCEQ-11): A self-administered questionnaire assessing five subscales: Satisfaction, Psychological Reward, Enjoyment of Respiratory Tract Sensations, Craving Reduction, and Aversion.
Items are scored on a 7-point Likert-like scale.
The items in this measure can be answered on a Likert-like scale response options ranging from 0 (Not at all) to 6 (Extremely).
The total score is calculated by summing the four subscales, with higher scores indicating greater reinforcing and aversive
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Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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Importance of Quitting Smoking
Time Frame: Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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A ruler-based question asking, "How important is it to quit smoking?" with answers ranging from 1 (no importance) to 10 (maximum importance).
with higher scores indicating higher Importance.
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Baseline, Post-intervention (8 weeks), and 3-month follow-up.
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Confidence in Quitting Smoking
Time Frame: Baseline, Post-intervention (8 weeks), and 3-month follow-up
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A ruler-based question asking, "How confident do you feel succeeding at quitting smoking?" with answers ranging from 1 (no confidence) to 10 (maximum confidence).
with higher scores indicating higher confidence
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Baseline, Post-intervention (8 weeks), and 3-month follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Motivational Interviewing
- 20240629 (Other Grant/Funding Number: Jordan University of Science and Technology)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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