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| ID | Type | Description | Link |
|---|---|---|---|
| 20240629 | Other Grant/Funding Number | Jordan University of Science and Technology |
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| Name | Class |
|---|---|
| Jordan University of Science and Technology | OTHER |
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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 OverviewThe goal of this randomized controlled trial is to evaluate the effectiveness of a Modified Motivational Interviewing (MMI) intervention specifically designed for university students who smoke. While traditional Motivational Interviewing (MI) is effective, it often requires highly skilled practitioners and significant time, making it costly and difficult to implement widely in a campus setting. This study tests a simplified, cost-effective version of the approach that uses participant-recorded videos to facilitate "change talk".The Intervention (MMI)Participants assigned to the intervention group will participate in an 8-week program. They will use their own devices, such as cell phones, to record a series of 15-minute videos. These videos focus on four specific categories of change talk:Identifying the advantages of quitting smoking.Expressing optimism about their ability to change.Stating their intentions to change their behavior.Discussing the disadvantages of their current smoking status.Researchers provide individualized feedback on each video to ensure the content aligns with these categories before the participant moves on to the next recording. Participants also have the option to share their videos within a private, virtual thread to connect with others in the intervention group.Comparison and Data Collection The study compares the intervention group to a control group that receives no intervention during the active study period. Data is collected from both groups at three distinct time points: Baseline: Before the intervention begins. Post-Intervention: Immediately following the 8-week program. Follow-up: Three months after the program has ended to assess long-term behavior change. Objectives and Measurement The primary objective is to determine if there is a statistically significant difference between the two groups regarding several key smoking-related variables. The study will measure: Physical nicotine dependence using the Fagerstrom Test. Readiness and motivation to quit smoking. Reinforcing and aversive effects of smoking via the Modified E-Cigarette Evaluation Questionnaire (MCEQ).Confidence and perceived importance of quitting smoking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants who receive the Modified Motivational Interviewing |
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| Control Group | No Intervention | Participants who receive no intervention during the active study period but are monitored simultaneously with the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Motivational Interviewing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reinforcing and Aversive Effects of Smoking | 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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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science and Technology | Irbid | 21110 | Jordan |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2026 | May 5, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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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.
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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.
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| Baseline, Post-intervention (8 weeks), and 3-month follow-up. |
| Importance of Quitting Smoking | 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. | Baseline, Post-intervention (8 weeks), and 3-month follow-up. |
| Confidence in Quitting Smoking | 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 | Baseline, Post-intervention (8 weeks), and 3-month follow-up |