StressNCT03184389
Sense2Stop:Mobile Sensor Data to Knowledge
A study testing Prompt to use smartphone apps for stress management in people with Stress and Smoking Cessation, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress, Smoking Cessation, Overeating
- What is being tested?
- Prompt to use smartphone apps for stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Stress, Smoking Cessation, Overeating
- Being tested
- Prompt to use smartphone apps for stress management
- Keywords
- Behavioral Counseling, Cigarette Smoking, Mobile Health, Heart Rate Variability Monitoring, Mindfulness-Based Exercises, Mobile Apps, Physiological Monitoring, Respiratory Pattern Monitoring, Stress-Management Interventions, Sensor-Triggered Stress Intervention, Smartphone Apps, Smoking Cessation, Wearable Sensors, Eating Behavior, Stress-Related Eating
- Medical subject headings
- Smoking Cessation, Hyperphagia, Cigarette Smoking, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prompt to use smartphone apps for stress managementBehavioural
Also called Headspace, Thought Shakeup, MoodSurfing
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.
| Study group | Role | What they receive |
|---|---|---|
| Within-participant micro-randomization | Other | 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. Receives: Behavioral: Prompt to use smartphone apps for stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of being stressed.
Measured: 2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking
Secondary outcomes (2)
First and all subsequent lapses in smoking cessation.
Measured: 10 days
Overeating episodes
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start23 Jun 2017
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Memphis, Georgia Institute of Technology, University of Minnesota, 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
- Responsible party
- Principal investigator, Bonnie Spring, Northwestern University
- Investigators
- Bonnie Spring, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184389
- Sponsor's protocol ID
- U54EB020404
- Status last verified
- Oct 2019
- First submitted
- 8 Jun 2017
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26543927Kumar 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.
PubMed 26555017Sarker 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.
PubMed 28058409Klasnja 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(0):1220-8. doi: 10.1037/hea0000305.
PubMed 26651463
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03184389
- Acronym / sponsor ID
- U54EB020404
- Conditions
- Stress, Smoking Cessation, Overeating
- Keywords
- Behavioral Counseling, Cigarette Smoking, Mobile Health, Heart Rate Variability Monitoring, Mindfulness-Based Exercises, Mobile Apps, Physiological Monitoring, Respiratory Pattern Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Memphis, Georgia Institute of Technology, University of Minnesota, 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
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Within-participant micro-randomization | Other | Behavioral: Prompt to use smartphone apps for stress managementEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prompt to use smartphone apps for stress managementAlso: Headspace, Thought Shakeup, MoodSurfingStudy 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. | Behavioural | Within-participant micro-randomization |
Primary outcome
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
2 secondary outcomes
First and all subsequent lapses in smoking cessation.
Time frame: 10 days
Overeating episodes
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Background: PubMed 26543927Saleheen 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.
- Background: PubMed 26555017Kumar 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.
- Background: PubMed 28058409Sarker 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.
- Background: PubMed 26651463Klasnja 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(0):1220-8. doi: 10.1037/hea0000305.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Spring, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prompt to use smartphone apps for stress management in people with Stress and Smoking Cessation, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03184389, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.