Sense2Stop:Mobile Sensor Data to Knowledge

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT03184389
Collaborator
University of Memphis (Other), Georgia Institute of Technology (Other), University of Minnesota (Other), Ohio State University (Other), University of Massachusetts, Amherst (Other), University of Michigan (Other), University of California, Los Angeles (Other), University of California, San Diego (Other), University of California, San Francisco (Other), University of Utah (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Prompt to use smartphone apps for stress management
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Jun 23, 2017
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Behavioral: 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.
Other Names:
  • Headspace, Thought Shakeup, MoodSurfing
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. First and all subsequent lapses in smoking cessation. [10 days]

    2. Overeating episodes [10 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University
    • University of Memphis
    • Georgia Institute of Technology
    • University of Minnesota
    • Ohio State University
    • University of Massachusetts, Amherst
    • University of Michigan
    • University of California, Los Angeles
    • University of California, San Diego
    • University of California, San Francisco
    • University of Utah

    Investigators

    • Principal Investigator: Bonnie Spring, PhD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    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, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT03184389
    Other Study ID Numbers:
    • U54EB020404
    First Posted:
    Jun 12, 2017
    Last Update Posted:
    Oct 4, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 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, Northwestern University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 4, 2019