Cigarette Smoking, Nicotine Dependence, Smoking Cessation, Tobacco Use
Conditions
Keywords
Mindful smoking, Smoking cessation, Mindfulness, Smartphone-based sensor-band, WHOOP sensor-band, Tobacco cessation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindful Smoking and Sensor-Band Intervention
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.
BEHAVIORALSmoking Cessation Information
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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes will be assessed by research team members blinded to the intervention assignment.
Intervention model description
Participants will be randomized to either the mindful smoking and smartphone-based sensor-band intervention group or the smoking cessation information control group. Participants in the intervention group will receive mindful smoking guidance, sensor-band instructions, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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. |
| Time to recruit target sample | 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. |
| Intervention uptake rate | 8 weeks | Intervention uptake rate will be measured as the percentage of participants who complete the intervention. |
| Attrition rate | 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. |
| Client satisfaction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 8-week smoking abstinence rate | 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-week smoking reduction | 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. |
| 4-month smoking abstinence rate | 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-month smoking reduction | 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. |
| Stress level | 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. |
| Self-control and management level | 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. |
| Mindfulness level | 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. |
| Respiratory Rate Measured by Smartphone-Based Sensor-Band | 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. |
| Heart Rate Variability Measured by Smartphone-Based Sensor-Band | 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. |
| Skin Temperature Measured by Smartphone-Based Sensor-Band | During the 8-week intervention period | Skin temperature will be measured in degrees Fahrenheit using the smartphone-based sensor-band among intervention group participants. |
| Resting Heart Rate Measured by Smartphone-Based Sensor-Band | 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. |
| Heart rate during craving and mindful smoking practice | 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. |
Countries
United States
Contacts
CONTACTFang Lei, PhD, MSN, MPH, RN
PRINCIPAL_INVESTIGATORFang Lei, PhD, MSN, MPH, RN
University of Minnesota
Outcome results
None listed