Sense2Stop:Mobile Sensor Data to Knowledge

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184389
• Other study ID #: U54EB020404
• Status: Completed
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Hyperphagia
• Overeating
• Smoking Cessation
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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

External Links

•   The Mobile Sensor Data-to-Knowledge Center of Excellence is one of 13 national Big Data Centers of Excellence awarded by the National Institutes of Health as part of its Big Data-to-Knowledge initiative.