Sense2Stop Mobile Sensor Data to Knowledge: Preliminary Study of the Effects of Wearable Sensors and Smartphone Apps on Real Time Stress and Smoking in Recently Quit Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Probability of being stressed.
研究概览
简要总结
The aim of this research is to build systems that can recognize when people are stressed and then provide them with relaxation prompts in the moment to reduce their likelihood of being stressed, smoking, or overeating in the near future. Using these systems should help smokers be more effective in their attempts to quit by reducing their tendency to lapse when they are stressed or experiencing other negative moods or behaviors.
详细描述
The purpose of this study is (1) to evaluate the feasibility of a just-in-time intervention to decrease stress in recently quit smokers; and (2) to examine whether a just-in-time adaptive intervention that decreases stress also reduces the near-term odds of a smoking lapse.
The primary hypothesis of this study is that the administration of a prompt to perform a relaxation exercise as compared to no prompt will lead to a lower likelihood of being stressed in the subsequent two hours, and that this effect will be stronger when the prompt is administered when the individual is stressed. The secondary hypothesis is that stress episodes will predict the timing of smoking lapses. The third hypothesis is that administration of a prompt to perform a relaxation exercise will reduce the odds of smoking for the next two hours, and that this effect will be stronger when the prompt is administered when the individual is stressed. The fourth (exploratory) hypothesis is that stress will predict the timing of overeating episodes.
These data will also be used for developing automated risk prediction of smoking relapse, and for developing decision rules for the timing of Just-In-Time-Adaptive Interventions (JITAIs).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smokes 1+ cigarettes/day for past year
- •Willing to try to quit smoking for at least 48 hours during a 15-day quit trial
- •Will not use non-cigarette tobacco products or nicotine replacement therapy during the study period
- •Not taking or intending to take pharmacological smoking cessation aids (e.g., nicotine replacement, bupropion, venlafaxene) during the study period
排除标准
- •Unable to wear study devices due to skin irritation or sizing limitations
- •Planning to move outside of Chicago area during study period
- •Adults unable to provide informed consent
- •Individuals who are not yet adults
- •Pregnant women
- •Prisoners
- •Non-English Speakers
研究组 & 干预措施
Within-participant micro-randomization
Each minute when participant is available is randomly assigned to either intervention (to practice a stress management exercise) vs. no intervention prompt. When intervention occurs, participant's smartphone vibrates and relaxation app opens, prompting performance of a relaxation exercise.
干预措施: Prompt to use smartphone apps for stress management (Behavioral)
结局指标
主要结局
Probability of being stressed.
时间窗: 2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking
次要结局
- First and all subsequent lapses in smoking cessation.(10 days)
- Overeating episodes(10 days)
研究者
Bonnie Spring
Director, Center for Behavior and Health-Institute for Public Health and Medicine (IPHAM); Professor of Preventive Medicine (Behavioral Medicine), Psychiatry, Psychology, and Public Health
Northwestern University