Sense2Stop:Mobile Sensor Data to Knowledge
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|ClinicalTrials.gov Identifier: NCT03184389|
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stress Smoking Cessation Overeating||Behavioral: Prompt to use smartphone apps for stress management||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|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)|
|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|
|Actual Study Start Date :||June 23, 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2019|
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.
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
- 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 ]
- First and all subsequent lapses in smoking cessation. [ Time Frame: 10 days ]
- Overeating episodes [ Time Frame: 10 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184389
|Contact: Elyse Dalyfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Angela Pfammatter 312-503-1574 email@example.com|
|Principal Investigator: Bonnie J Spring, PhD|
|Principal Investigator:||Bonnie Spring, PhD||Northwestern University|