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Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation

2026年9月9日 更新者:University of Minnesota

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Fang Lei, PhD, MSN, MPH, RN
  • 電話番号:612-626-7021
  • メール:flei@umn.edu

研究場所

    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55455
        • University of Minnesota School of Nursing
        • コンタクト:
          • Fang Lei, PhD, MSN, MPH, RN
          • 電話番号:612-626-7021
          • メール:flei@umn.edu
        • 主任研究者:
          • Fang Lei, PhD, MSN, MPH, RN

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.
他の名前:
  • Quit With Sense
アクティブコンパレータ: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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Recruitment rate
時間枠:Baseline / recruitment period, up to 6 months
Recruitment rate will be measured as the proportion of eligible participants who agree to participate in the study.
Baseline / recruitment period, up to 6 months
Time to recruit target sample
時間枠:Up to 6 months
Time to recruit the target sample will be measured as the duration of time required to recruit the target sample size.
Up to 6 months
Intervention uptake rate
時間枠:8 weeks
Intervention uptake rate will be measured as the percentage of participants who complete the intervention.
8 weeks
Attrition rate
時間枠:Up to 4 months after completion of the 8-week intervention
Attrition rate will be measured as the percentage of participants who drop out before completing the study.
Up to 4 months after completion of the 8-week intervention
Client satisfaction
時間枠:8 weeks

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

二次結果の測定

結果測定
メジャーの説明
時間枠
8-week smoking abstinence rate
時間枠:8 weeks
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.
8 weeks
8-week smoking reduction
時間枠:Baseline to 8 weeks
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.
Baseline to 8 weeks
4-month smoking abstinence rate
時間枠:4 months after completion of the intervention
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.
4 months after completion of the intervention
4-month smoking reduction
時間枠:Baseline to 4 months after completion of the intervention
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.
Baseline to 4 months after completion of the intervention
Stress level
時間枠:Baseline to 8 weeks
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.
Baseline to 8 weeks
Self-control and management level
時間枠:Baseline to 8 weeks

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
Mindfulness level
時間枠:Baseline to 8 weeks
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.
Baseline to 8 weeks
Respiratory Rate Measured by Smartphone-Based Sensor-Band
時間枠:During the 8-week intervention period
Respiratory rate will be measured in breaths per minute using the smartphone-based sensor-band among intervention group participants.
During the 8-week intervention period
Heart Rate Variability Measured by Smartphone-Based Sensor-Band
時間枠:During the 8-week intervention period

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
Skin Temperature Measured by Smartphone-Based Sensor-Band
時間枠:During the 8-week intervention period
Skin temperature will be measured in degrees Fahrenheit using the smartphone-based sensor-band among intervention group participants.
During the 8-week intervention period
Resting Heart Rate Measured by Smartphone-Based Sensor-Band
時間枠:During the 8-week intervention period
Resting heart rate will be measured in beats per minute using the smartphone-based sensor-band among intervention group participants.
During the 8-week intervention period
Heart rate during craving and mindful smoking practice
時間枠:During the 8-week intervention period
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.
During the 8-week intervention period

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Fang Lei, PhD, MSN, MPH, RN、University of Minnesota

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月10日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2026年8月3日

QC基準を満たした最初の提出物

2026年8月24日

最初の投稿 (実際)

2026年8月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月10日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

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医薬品およびデバイス情報、研究文書

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米国FDA規制機器製品の研究

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