Smartband Mindfulness Study

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

Detailed Description
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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.

Official Title
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Smartband/Smartphone-based Automatic Smoking Detection and Real Time Mindfulness Intervention

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Smartband automatic smoking detection combined with brief mindfulness interventions


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smokers<br>This study involves wearing a smartband to monitor, record and notify smokers of smoking events and deliver real-time brief mindfulness exercises by smartphone app. There is only one arm. | Behavioral: Smartband automatic smoking detection combined with brief mindfulness interventions<br>* Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions and learn to work mindfully with cravings and triggers rather than smoke using RAIN prior to smoking episodes.This is a 3 step intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fidelity of Detecting Smoking Episodes | Percent of smoking episodes detected and the rate of false alarms in the first 60 days of the study during which smokers are wearing the smartband to monitor, detect and notify them of smoking episodes. | 60 days | 
| Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking | Percent of mindful smoking exercises correctly triggered by detected smoking episodes and the rate of false alarms during which any detected and confirmed smoking event triggers the mindful smoking exercise. | 39 days | 
| Timeliness of Delivering RAIN Exercise | Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating timeliness of RAIN exercise as moderate or higher (via real-time ecological momentary assessment). Moderate or higher indicates a better (more timely) outcome. | 30 days | 
| Adherence to Wearing the Smartband | Percent of days spent wearing the smartband. | 60 days | 
| Adherence to Answering Smartband Notifications of Smoking Events | Percent of smoking notifications answered | 60 days | 
| Adherence to Answering Ecological Momentary Assessment Items | Percentage of ecological momentary assessment (EMA) ratings (e.g., timeliness, helpfulness, craving, affect) answered when participants completed mindfulness exercises. That is, did the participant complete the EMA when they completed the mindfulness exercise. Measured separately for percentage of EMA answered when participants completed RAIN exercises, and percentage of EMA answered when participants completed mindful smoking exercises. Reported is the percentage of EMA answered out of the number of completed mindfulness exercises, separately for RAIN and mindful smoking. | 60 days | 
| Adherence to Completing Mindfulness Exercises | Percent of mindfulness exercises (RAIN, mindful smoking) completed | 60 days | 
| Acceptability of Intervention - Helpfulness of Mindfulness Exercises | Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating helpfulness as moderate or higher of participants that completed at least one mindful smoking or RAIN exercise. | 60 days | 
| Acceptability of Intervention - User Experiences Survey | Feedback on user experiences survey (e.g., whether there were too many or not enough interventions) by theme- One survey with feasibility determined by 75% of participants rating the question as moderate or higher. Below are percentage of participants with ratings of moderate or higher for each question. | up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Self-reported Abstinence From Smoking | As a secondary aim we will also evaluate self-reported one-week point prevalence abstinence from smoking and prolonged abstinence from smoking (≤5 cigarettes since quit date) | 7 days |