Sense2Stop:Mobile Sensor Data to Knowledge

Northwestern University

Status: Completed

Conditions: Overeating; Smoking Cessation; Stress

Treatments: Behavioral: Prompt to use smartphone apps for stress management

Study type: Interventional

Funder types: Other

Identifiers

NCT03184389

U54EB020404

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Within-participant micro-randomization

Other group

Description:

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.

Treatment:

Behavioral: Prompt to use smartphone apps for stress management