Applying mHealth to Tobacco-related Health Disparities: Enhancing Aspects of Resiliency to Aid Cessation Efforts (Time2Quit)
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Rate of Stress
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Smoking Cessation Therapy
Participants will receive 6 weeks of the nicotine patch therapy and brief counseling sessions. Participants will also receive mindfulness strategies for 10 days during both the pre- and post-quit periods via smartphone to aid in their cessation attempt. AutoSense will be worn to detect stress and lapse throughout the 10 day period.
Intervention: Nicotine Patch (Drug)
Smoking Cessation Therapy
Participants will receive 6 weeks of the nicotine patch therapy and brief counseling sessions. Participants will also receive mindfulness strategies for 10 days during both the pre- and post-quit periods via smartphone to aid in their cessation attempt. AutoSense will be worn to detect stress and lapse throughout the 10 day period.
Intervention: Counseling (Behavioral)
Smoking Cessation Therapy
Participants will receive 6 weeks of the nicotine patch therapy and brief counseling sessions. Participants will also receive mindfulness strategies for 10 days during both the pre- and post-quit periods via smartphone to aid in their cessation attempt. AutoSense will be worn to detect stress and lapse throughout the 10 day period.
Intervention: Smartphone (Behavioral)
Smoking Cessation Therapy
Participants will receive 6 weeks of the nicotine patch therapy and brief counseling sessions. Participants will also receive mindfulness strategies for 10 days during both the pre- and post-quit periods via smartphone to aid in their cessation attempt. AutoSense will be worn to detect stress and lapse throughout the 10 day period.
Intervention: AutoSense (Other)
Outcomes
Primary Outcomes
Rate of Stress
Time Frame: Up to 36 months
Stress will be measured objectively and automatically from the equipment worn by participants (AutoSense).
Rate of Smoking Lapse
Time Frame: Up to 36 months
Lapse will be measured objectively and automatically from the equipment worn by participants (AutoSense).
Secondary Outcomes
No secondary outcomes reported