- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184389
Sense2Stop:Mobile Sensor Data to Knowledge
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Probability of being stressed.
Time Frame: 2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking
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2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
First and all subsequent lapses in smoking cessation.
Time Frame: 10 days
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10 days
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Overeating episodes
Time Frame: 10 days
|
10 days
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
- Saleheen N, Ali AA, Hossain SM, Sarker H, Chatterjee S, Marlin B, Ertin E, al'Absi M, Kumar S. puffMarker: A Multi-Sensor Approach for Pinpointing the Timing of First Lapse in Smoking Cessation. Proc ACM Int Conf Ubiquitous Comput. 2015 Sep;2015:999-1010.
- Kumar S, Abowd GD, Abraham WT, al'Absi M, Beck JG, Chau DH, Condie T, Conroy DE, Ertin E, Estrin D, Ganesan D, Lam C, Marlin B, Marsh CB, Murphy SA, Nahum-Shani I, Patrick K, Rehg JM, Sharmin M, Shetty V, Sim I, Spring B, Srivastava M, Wetter DW. Center of excellence for mobile sensor data-to-knowledge (MD2K). J Am Med Inform Assoc. 2015 Nov;22(6):1137-42. doi: 10.1093/jamia/ocv056. Epub 2015 Jul 3.
- Sarker H, Tyburski M, Rahman MM, Hovsepian K, Sharmin M, Epstein DH, Preston KL, Furr-Holden CD, Milam A, Nahum-Shani I, al'Absi M, Kumar S. Finding Significant Stress Episodes in a Discontinuous Time Series of Rapidly Varying Mobile Sensor Data. Proc SIGCHI Conf Hum Factor Comput Syst. 2016 May;2016:4489-4501. doi: 10.1145/2858036.2858218.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Mobile Health
- Smoking Cessation
- Eating Behavior
- Wearable Sensors
- Cigarette Smoking
- Mobile Apps
- Behavioral Counseling
- Smartphone Apps
- Heart Rate Variability Monitoring
- Mindfulness-Based Exercises
- Physiological Monitoring
- Respiratory Pattern Monitoring
- Stress-Management Interventions
- Sensor-Triggered Stress Intervention
- Stress-Related Eating
Additional Relevant MeSH Terms
Other Study ID Numbers
- U54EB020404 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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