期刊
CONTEMPORARY CLINICAL TRIALS
卷 109, 期 -, 页码 -出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2021.106534
关键词
Micro-randomized trial; Optimization; mHealth; Smoking; Stress; Digital intervention; Just-in-time adaptive intervention
资金
- NIH [U54EB020404, R01DK108678, R01DK125414, U01CA229437]
This study aims to investigate whether sending prompts for stress management behavior can reduce the likelihood of stress and smoking in the subsequent two hours for smokers. The research will utilize wearable sensors and smartphone apps to collect data and analyze in real-time, in order to optimize a just-in-time adaptive stress management intervention to prevent smoking relapse.
Background: Relapse to smoking is commonly triggered by stress, but behavioral interventions have shown only modest efficacy in preventing stress-related relapse. Continuous digital sensing to detect states of smoking risk and intervention receptivity may make it feasible to increase treatment efficacy by adapting intervention timing. Objective: Aims are to investigate whether the delivery of a prompt to perform stress management behavior, as compared to no prompt, reduces the likelihood of (a) being stressed and (b) smoking in the subsequent two hours, and (c) whether current stress moderates these effects. Study design: A micro-randomized trial will be implemented with 75 adult smokers who wear Autosense chest and wrist sensors and use the mCerebrum suite of smartphone apps to report and respond to ecological momentary assessment (EMA) questions about smoking and mood for 4 days before and 10 days after a quit attempt and to access a set of stress-management apps. Sensor data will be processed on the smartphone in real time using the cStress algorithm to classify minutes as probably stressed or probably not stressed. Stressed and non-stressed minutes will be micro-randomized to deliver either a prompt to perform a stress management exercise via one of the apps or no prompt (2.5-3 stress management prompts will be delivered daily). Sensor and self-report assessments of stress and smoking will be analyzed to optimize decision rules for a just-in-time adaptive intervention (JITAI) to prevent smoking relapse. Significance: Sense2Stop will be the first digital trial using wearable sensors and micro-randomization to optimize a just-in-time adaptive stress management intervention for smoking relapse prevention.
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