- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Irbid, Jordan, 21110
- Jordan University of Science and Technology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Ingen indgriben: Control Group
Participants who receive no intervention during the active study period but are monitored simultaneously with the intervention group.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Physical Dependence on Nicotine
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Reinforcing and Aversive Effects of Smoking
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Motivational Interviewing
- 20240629 (Andet bevillings-/finansieringsnummer: Jordan University of Science and Technology)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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