Clinical trial NCT03995225: Smartband Mindfulness Study
Official title: Smartband/Smartphone-based Automatic Smoking Detection and Real Time Mindfulness Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-06-21
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine treatment fidelity for a smartband/smartphone-based smoking monitoring, notification and brief mindfulness intervention.

Detailed description: This study will test the feasibility of using a smartband to detect and track smoking and deliver brief smoking cessation interventions by smartphone app in real time. Smokers will wear a smartband to detect and notify them of smoking for 21 days and obtain individual smoking profiles; detected smoking will then trigger a "mindful smoking" exercise for the next 7 days leading up to their quit date at 30 days; after which another mindfulness exercise ("RAIN": recognize, accept, investigate and note cravings rather than smoke) will be delivered prior to each predicted smoking episode according to their individual smoking profile for 30 days post-quit.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Daily smokers (≥ 5 cigarettes per day)
* Daily smoker for at least 2 years
* Own an Android phone or iPhone
* Fluent in English as study content is currently only available in English
* \>18 of 20 on the Action subscale of the Readiness to Change Questionnaire

Exclusion Criteria:

* E-cigarette use (some days/every day)

Primary outcomes:
measure: Fidelity of Detecting Smoking Episodes
timeFrame: 60 days
measure: Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking
timeFrame: 39 days
measure: Timeliness of Delivering RAIN Exercise
timeFrame: 30 days
measure: Adherence to Wearing the Smartband
timeFrame: 60 days
measure: Adherence to Answering Smartband Notifications of Smoking Events
timeFrame: 60 days
measure: Adherence to Answering Ecological Momentary Assessment Items
timeFrame: 60 days
measure: Adherence to Completing Mindfulness Exercises
timeFrame: 60 days
measure: Acceptability of Intervention - Helpfulness of Mindfulness Exercises
timeFrame: 60 days
measure: Acceptability of Intervention - User Experiences Survey
timeFrame: up to 60 days
Secondary outcomes:
measure: Number of Participants With Self-reported Abstinence From Smoking
timeFrame: 7 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen A Garrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horvath M, Grutman A, O'Malley SS, Gueorguieva R, Khan N, Brewer JA, Garrison KA. Smartband-Based Automatic Smoking Detection and Real-time Mindfulness Intervention: Protocol for a Feasibility Trial. JMIR Res Protoc. 2021 Nov 16;10(11):e32521. doi: 10.2196/32521.