MedPath

Sense2Stop:Mobile Sensor Data to Knowledge

Not Applicable
Completed
Conditions
Overeating
Smoking Cessation
Stress
Interventions
Behavioral: Prompt to use smartphone apps for stress management
Registration Number
NCT03184389
Lead Sponsor
Northwestern University
Brief Summary

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

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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Within-participant micro-randomizationPrompt to use smartphone apps for stress managementEach 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.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
First and all subsequent lapses in smoking cessation.10 days
Overeating episodes10 days

Trial Locations

Locations (1)

Northwestern University

🇺🇸

Chicago, Illinois, United States

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