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Sense2Stop:Mobile Sensor Data to Knowledge

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ClinicalTrials.gov Identifier: NCT03184389
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
University of Memphis
Georgia Institute of Technology
University of Minnesota, MN
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
Information provided by (Responsible Party):
Bonnie Spring, Northwestern University

Tracking Information
First Submitted Date  ICMJE June 8, 2017
First Posted Date  ICMJE June 12, 2017
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE June 23, 2017
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03184389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • First and all subsequent lapses in smoking cessation. [ Time Frame: 10 days ]
  • Overeating episodes [ Time Frame: 10 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sense2Stop:Mobile Sensor Data to Knowledge
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Stress
  • Smoking Cessation
  • Overeating
Intervention  ICMJE 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 Name: Headspace, Thought Shakeup, MoodSurfing
Study Arms  ICMJE 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.
Intervention: Behavioral: Prompt to use smartphone apps for stress management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2017)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03184389
Other Study ID Numbers  ICMJE U54EB020404( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Following completion of this study, a de-identified dataset, (i.e., containing no raw location/GPS information), will be generated and made available to interested researchers upon request. The dataset will be stripped of any information that could be linked back to the original data or to an individual participant. Prospective users of this dataset must sign a confidentiality agreement, requiring that they must get permission from the MD2K Center to share the data with anyone else. All external requests for data will be directed to Dr. Bonnie Spring and routed through the MD2K Center. Prospective investigators will submit a written proposal to the MD2K Executive Committee outlining the question they will investigate, the specific variables that they need to answer that question, their analytic plan for answering that question, and documentation of sufficient Institutional Review Board oversight. Investigators will also need to sign a confidentiality agreement.
Responsible Party Bonnie Spring, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • University of Memphis
  • Georgia Institute of Technology
  • University of Minnesota, MN
  • 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  ICMJE
Principal Investigator: Bonnie Spring, PhD Northwestern University
PRS Account Northwestern University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP