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Completed

NCT Number: NCT03184389

Sense2Stop:Mobile Sensor Data to Knowledge

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prompt to use smartphone apps for stress management

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. First and all subsequent lapses in smoking cessation.

    Time frame: 10 days

  2. Overeating episodes

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • 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
  • University of Utah

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2017
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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