- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07789496
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Quit With Sense: A Pilot Smoking Cessation Intervention Study Using Mindful Smoking and Smartphone-Based Sensor-Band
This pilot randomized controlled trial will test the feasibility of a smoking cessation intervention using mindful smoking practice and a smartphone-based sensor-band among adults who regularly smoke cigarettes.
Participants will be randomized to either an intervention group or a control group. Participants in the intervention group will receive a one-on-one mindful smoking guidance session, instructions for using a smartphone-based sensor-band, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information. The intervention period will last 8 weeks, with assessments at baseline, 8 weeks, and 4 months after completion of the intervention.
The study will evaluate feasibility, preliminary smoking cessation outcomes, and physiologic parameters including heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.
Přehled studie
Postavení
Detailní popis
Cigarette smoking is a leading preventable cause of morbidity and mortality and contributes to cancer, lung disease, health care costs, and reduced quality of life. Although many adults who smoke cigarettes attempt to quit, long-term cessation rates remain low. Mindfulness-based strategies may help people who smoke manage cravings by increasing awareness of present-moment thoughts, emotions, and physical sensations without automatically reacting by smoking.
This pilot randomized controlled trial will evaluate a smoking cessation intervention that combines mindful smoking practice with use of a smartphone-based sensor-band. The study will enroll 30 adults who regularly smoke cigarettes and are motivated to quit smoking or make a quit attempt. Participants will be randomly assigned to an intervention group or a control group, with approximately 15 participants in each group.
Participants in the intervention group will receive a one-hour, one-on-one, in-person mindful smoking guidance session from a certified mindfulness instructor. The session will teach participants to manage cravings mindfully using the RAIN method: Recognize, Accept, Investigate, and Note. Participants will also receive a mindfulness practice video for home practice and in-person instruction from a research assistant on use of the smartphone-based sensor-band. During the 8-week self-management and intervention period, participants in the intervention group will be instructed to practice mindful smoking when they feel a craving to smoke. They will be asked to record their craving level, duration of mindful smoking practice, feelings after mindful smoking, heart rate at the time of craving, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.
Participants in the control group will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials. Control group participants will be asked to record their daily cigarette smoking activities.
Data will be collected at baseline, 8 weeks after the intervention begins, and 4 months after the intervention is completed. Feasibility will be assessed by recruitment rate, time to recruit the target sample, intervention uptake rate, attrition rate, and participant satisfaction. Preliminary effectiveness will be assessed by 8-week and 4-month smoking abstinence rates and smoking reduction. Smoking abstinence will be confirmed using exhaled carbon monoxide measurement. The study will also assess stress level, self-control and management level, mindfulness level, heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Fang Lei, PhD, MSN, MPH, RN
- Telefonní číslo: 612-626-7021
- E-mail: flei@umn.edu
Studijní místa
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55455
- University of Minnesota School of Nursing
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Kontakt:
- Fang Lei, PhD, MSN, MPH, RN
- Telefonní číslo: 612-626-7021
- E-mail: flei@umn.edu
-
Vrchní vyšetřovatel:
- Fang Lei, PhD, MSN, MPH, RN
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Aged 18 years and older
- Smoking at least 5 cigarettes per day on average over the past 3 months
- Motivated to quit smoking, indicated by answering "yes" to being interested in quitting smoking or making a quit attempt in the next 30 days
- Has a functioning Android or iOS smartphone
- Has a telephone number available for contact
Exclusion Criteria:
- Recent change in the dosage or type of new medications, if taking medications, or unstable medical situation in the past 3 months
- Active substance dependence other than nicotine
- Use of other non-cigarette tobacco products, including e-cigarettes, more than 15 days per month
- Another household member enrolled in the study
- Participation in a smoking cessation program in the past 30 days
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Mindful Smoking and Sensor-Band Intervention
Participants in this arm will receive a one-hour, one-on-one mindful smoking guidance session from a certified mindfulness instructor, instruction on use of the smartphone-based sensor-band, a mindfulness practice video for home practice, and smoking cessation information.
During the 8-week intervention period, participants will be instructed to practice mindful smoking when they feel a craving to smoke and to record craving level, duration of mindful smoking practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.
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The intervention includes a one-hour, one-on-one mindful smoking guidance session using the RAIN method, which includes Recognize, Accept, Investigate, and Note.
Participants will also receive a mindfulness practice video and instructions for using a smartphone-based sensor-band.
During the 8-week intervention period, participants will practice mindful smoking when they feel a craving to smoke and will record craving level, duration of practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily smoking activities.
Ostatní jména:
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Aktivní komparátor: Smoking Cessation Information Control
Participants in this arm will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials.
Participants will be asked to record their daily cigarette smoking activities in a paper notebook.
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Participants will receive smoking cessation information published by the American Lung Association, including printed materials such as The Smoking Health Effects brochure and Top Tips for Quitting Smoking.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Recruitment rate
Časové okno: Baseline / recruitment period, up to 6 months
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Recruitment rate will be measured as the proportion of eligible participants who agree to participate in the study.
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Baseline / recruitment period, up to 6 months
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Time to recruit target sample
Časové okno: Up to 6 months
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Time to recruit the target sample will be measured as the duration of time required to recruit the target sample size.
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Up to 6 months
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Intervention uptake rate
Časové okno: 8 weeks
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Intervention uptake rate will be measured as the percentage of participants who complete the intervention.
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8 weeks
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Attrition rate
Časové okno: Up to 4 months after completion of the 8-week intervention
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Attrition rate will be measured as the percentage of participants who drop out before completing the study.
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Up to 4 months after completion of the 8-week intervention
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Client satisfaction
Časové okno: 8 weeks
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Client satisfaction will be assessed using the Satisfaction Feedback Questionnaire, adapted from the Client Satisfaction Questionnaire. It has 4 questions with ordinal level options. The value of the scare measurement ranges from 0 to 12. Higher score means a higher satisfaction level. |
8 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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8-week smoking abstinence rate
Časové okno: 8 weeks
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Smoking abstinence at 8 weeks will be measured as the percentage of participants who quit smoking at the 8-week time point.
Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.
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8 weeks
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8-week smoking reduction
Časové okno: Baseline to 8 weeks
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Smoking reduction at 8 weeks will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 8-week time point.
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Baseline to 8 weeks
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4-month smoking abstinence rate
Časové okno: 4 months after completion of the intervention
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Smoking abstinence at 4 months after intervention completion will be measured as the percentage of participants who quit smoking at the 4-month follow-up time point.
Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.
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4 months after completion of the intervention
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4-month smoking reduction
Časové okno: Baseline to 4 months after completion of the intervention
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Smoking reduction at 4 months after intervention completion will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 4-month follow-up time point.
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Baseline to 4 months after completion of the intervention
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Stress level
Časové okno: Baseline to 8 weeks
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Stress level will be assessed using the Perceived Stress Scale.
It has 10 questions with ordinal level options.
The value of the scare measurement ranges from 0 to 40.
Higher score means a higher stress level.
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Baseline to 8 weeks
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Self-control and management level
Časové okno: Baseline to 8 weeks
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Self-control and management level will be assessed using the Self-control and Management Scale. It has 16 questions with ordinal level options. The value of the scare measurement ranges from 0 to 80. Higher score means a higher self-control and management level. |
Baseline to 8 weeks
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Mindfulness level
Časové okno: Baseline to 8 weeks
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Mindfulness level will be assessed using the Mindful Attention Awareness Scale.
It has 15 questions with ordinal level options.
The value of the scare measurement ranges from 0 to 75.
Higher score means a higher mindful attention awareness level.
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Baseline to 8 weeks
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Respiratory Rate Measured by Smartphone-Based Sensor-Band
Časové okno: During the 8-week intervention period
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Respiratory rate will be measured in breaths per minute using the smartphone-based sensor-band among intervention group participants.
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During the 8-week intervention period
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Heart Rate Variability Measured by Smartphone-Based Sensor-Band
Časové okno: During the 8-week intervention period
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Physiologic parameters including respiratory rate, heart rate variation, skin temperature, and resting heart rate will be collected using the smartphone-based sensor-band among intervention group participants. Physiologic parameters including respiratory rate measured by breaths per minute, heart rate variation measured by milliseconds, skin temperature measured by Farehent degree, and resting heart rate measured by heart beats per minute, will be collected using the smartphone-based sensor-band among intervention group participants. |
During the 8-week intervention period
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Skin Temperature Measured by Smartphone-Based Sensor-Band
Časové okno: During the 8-week intervention period
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Skin temperature will be measured in degrees Fahrenheit using the smartphone-based sensor-band among intervention group participants.
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During the 8-week intervention period
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Resting Heart Rate Measured by Smartphone-Based Sensor-Band
Časové okno: During the 8-week intervention period
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Resting heart rate will be measured in beats per minute using the smartphone-based sensor-band among intervention group participants.
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During the 8-week intervention period
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Heart rate during craving and mindful smoking practice
Časové okno: During the 8-week intervention period
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Real-time heart rate will be measured at the time of cigarette craving and at the end of mindful smoking practice among intervention group participants.
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During the 8-week intervention period
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Fang Lei, PhD, MSN, MPH, RN, University of Minnesota
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Poruchy související s látkami
- Chemicky indukované poruchy
- Chování
- Kouření
- Zdravotní chování
- Kouření tabáku
- Porucha užívání tabáku
- Odvykání kouření
- Kouření cigaret
- Užívání tabáku
- Ukončení užívání tabáku
- Muskuloskeletální a nervové fyziologické jevy
- Fyziologické jevy nervového systému
- Sensation
Další identifikační čísla studie
- SON-2024-32759
- STUDY00022693 (Jiný identifikátor: University Of Minnesota)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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