Stress Clinical Trial
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
Verified date | October 2019 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | August 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Georgia Institute of Technology, Ohio State University, University of California, Los Angeles, University of California, San Diego, University of California, San Francisco, University of Massachusetts, Amherst, University of Memphis, University of Michigan, University of Minnesota, MN, University of Utah |
United States,
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:1220-8. doi: 10.1037/hea0000305. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Probability of being stressed. | 2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking | ||
Secondary | First and all subsequent lapses in smoking cessation. | 10 days | ||
Secondary | Overeating episodes | 10 days |
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