Sense2Stop:Mobile Sensor Data to Knowledge

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Stress, Overeating, Smoking Cessation

Intervention / Treatment
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* Behavioral: Prompt to use smartphone apps for stress management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Each time point when participant is available (i.e., not driving, not physically active, a stress classification is possible, hasn't recently received an ecological momentary assessment (EMA) or an intervention prompt) is randomly assigned to intervention prompt or no prompt.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Within-participant micro-randomization<br>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. | Behavioral: Prompt to use smartphone apps for stress management<br>* Study smartphone and software will be used to deliver intervention prompts to use stress management applications on the study smartphone at various times throughout the day, during at least 10 days of study participation. The delivery of prompts will be micro randomized to occur when participants are classified as stressed, and when participants are not classified as stressed. Headspace, a commercial stress management application, will be installed on the study smartphones. Thought Shakeup and Mood Surfing, stress management applications that are not commercially available, also will be installed on the study smartphones. These smartphone applications guide participants through stress management exercises that draw upon techniques from mindfulness, cognitive behavioral therapy, and acceptance and commitment therapy.<br>* Other names: Headspace, Thought Shakeup, MoodSurfing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of being stressed. |  | 2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First and all subsequent lapses in smoking cessation. |  | 10 days | 
| Overeating episodes |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile Apps, Physiological Monitoring, Respiratory Pattern Monitoring, Behavioral Counseling, Cigarette Smoking, Mobile Health, Heart Rate Variability Monitoring, Mindfulness-Based Exercises, Stress-Management Interventions, Sensor-Triggered Stress Intervention, Smartphone Apps, Smoking Cessation, Wearable Sensors, Eating Behavior, Stress-Related Eating