- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Irbid, Иордания, 21110
- Jordan University of Science and Technology
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Без вмешательства: Control Group
Participants who receive no intervention during the active study period but are monitored simultaneously with the intervention group.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Physical Dependence on Nicotine
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Reinforcing and Aversive Effects of Smoking
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Motivational Interviewing
- 20240629 (Другой номер гранта/финансирования: Jordan University of Science and Technology)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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