Smoking Cessation
Conditions
Keywords
cigarettes, quit smoking, nicotine, mindfulness, mHealth, mobile health
Brief summary
The purpose of this study is to better understand what happens when someone attempts to quit smoking.
Detailed description
Investigators will provide participants with nicotine patches, smoking cessation treatment that will include brief counseling sessions (10-15 minutes each), and text messages sent to their provided study phone throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts. Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. Mobile Health (mHealth) is a general term for the use of mobile phones and other wireless technology in medical care. The key outcome and hypothesized mechanisms (i.e., lapse and stress) will be measured objectively and automatically using AutoSense. AutoSense is a type of human sensing technology that allows investigators to detect smoking behavior and stress objectively through a chest strap and wrist bands worn by participants. Ecological momentary assessment (EMA) will assess acute precipitants such as negative affect, craving, self-efficacy, motivation, alcohol consumption, etc. Questionnaires will assess other predictors and mechanisms.
Interventions
DRUGNicotine Patch
Nicotine patches and thorough education of the indications for the patch will be provided to all participants.
BEHAVIORALCounseling
Brief counseling sessions, 10-15 minutes each.
BEHAVIORALSmartphone
Ecological momentary assessment (EMA) assesses participants' moment-to-moment subjective experiences via self-report assessments on a smart phone. Participants will receive mindfulness strategies for 10 days pre- and post-quit via smart phone to aid in their cessation attempt. Text messages will be sent to provided study phones throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts.
OTHERAutoSense
Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. AutoSense unobtrusively and objectively collects physiological and behavioral data (i.e., negative affect (NA), self-regulatory capacity (SRC), and smoking) via wearable chest and wrist sensors.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Smoked a minimum of 3 cigarettes per day over the past year * Expired carbon monoxide reading ≥ 6 * Motivated to quit within the next 30 days * Valid home address * Functioning telephone number * Can speak, read, and write in English * At least marginal health literacy
Exclusion criteria
* Contraindication for the nicotine patch (e.g., heart attack, angina, skin allergies) unless a doctor's note is provided * Endorse current psychosis * Have a pacemaker or implanted device * Physically unable to wear equipment and provide a good reading of physiological measures * Current use of tobacco cessation medications * Current use of of smoking products other than cigarettes and e-cigarettes * Involvement in a smoking program or currently trying to quit * Pregnancy or lactation * Another household member being enrolled in the study * No prior experience with a smart phone * The study staff or principal investigator (PI) have serious concerns about the participant's ability to engage in and/or complete the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Smoking Lapse | Up to 36 months | Lapse will be measured objectively and automatically from the equipment worn by participants (AutoSense). |
| Rate of Stress | Up to 36 months | Stress will be measured objectively and automatically from the equipment worn by participants (AutoSense). |
Countries
United States
Outcome results
None listed