Applying mHealth to Tobacco-related Health Disparities: Enhancing Aspects of Resiliency to Aid Cessation Efforts (Time2Quit)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of Stress
研究概览
简要总结
The purpose of this study is to better understand what happens when someone attempts to quit smoking.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: AutoSense (Other)
结局指标
主要结局
Rate of Stress
时间窗: Up to 36 months
Stress will be measured objectively and automatically from the equipment worn by participants (AutoSense).
Rate of Smoking Lapse
时间窗: Up to 36 months
Lapse will be measured objectively and automatically from the equipment worn by participants (AutoSense).
次要结局
未报告次要终点