Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mindful Smoking and Sensor-Band Intervention
BehavioralThe 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.
Smoking Cessation Information
BehavioralParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Mindful Smoking and Sensor-Band InterventionExperimental treatment 1 intervention
Group B: Smoking Cessation Information ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Recruitment rate will be measured as the proportion of eligible participants who agree to participate in the study.
Time frame
Baseline / recruitment period, up to 6 months2
Time to recruit target sample
Time to recruit the target sample will be measured as the duration of time required to recruit the target sample size.
Time frame
Up to 6 months3
Intervention uptake rate
Intervention uptake rate will be measured as the percentage of participants who complete the intervention.
Time frame
8 weeks4
Attrition rate
Attrition rate will be measured as the percentage of participants who drop out before completing the study.
Time frame
Up to 4 months after completion of the 8-week interventionSecondary outcomes
1
8-week smoking abstinence rate
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.
Time frame
8 weeks2
8-week smoking reduction
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.
Time frame
Baseline to 8 weeks3
4-month smoking abstinence rate
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.
Time frame
4 months after completion of the intervention4
4-month smoking reduction
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.
Time frame
Baseline to 4 months after completion of the interventionSponsors and contacts
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Source ClinicalTrials.gov
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