Sense2Stop:Mobile Sensor Data to Knowledge

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-23

Study Completion Date

2019-08-01

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.

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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).

Conditions

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Stress Smoking Cessation Overeating

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Prompt to use smartphone apps for stress management

Intervention Type BEHAVIORAL

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.

Interventions

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Prompt to use smartphone apps for stress management

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Headspace, Thought Shakeup, MoodSurfing

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR