Smartband Mindfulness Study

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Smartband automatic smoking detection combined with brief mindfulness interventions

• Registration Number: NCT03995225
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-21
• Study Start: 2020-11-22
• Primary Completion: 2022-03-03
• Study Completion: 2022-03-03
• Disposition First Submitted: 2023-02-08
• Disposition First Submitted QC: 2023-02-08
• Disposition First Posted: 2023-02-13
• Results First Submitted: 2023-08-31
• Results First Submitted QC: 2023-10-26
• Results First Posted: 2023-11-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Smokers	Smartband automatic smoking detection combined with brief mindfulness interventions	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.

Primary Outcome Measures

Name	Time	Method
Fidelity of Detecting Smoking Episodes	60 days	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.
Acceptability of Intervention - User Experiences Survey	up to 60 days	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.
Adherence to Answering Smartband Notifications of Smoking Events	60 days	Percent of smoking notifications answered
Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking	39 days	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.
Timeliness of Delivering RAIN Exercise	30 days	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.
Adherence to Wearing the Smartband	60 days	Percent of days spent wearing the smartband.
Adherence to Answering Ecological Momentary Assessment Items	60 days	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.
Adherence to Completing Mindfulness Exercises	60 days	Percent of mindfulness exercises (RAIN, mindful smoking) completed
Acceptability of Intervention - Helpfulness of Mindfulness Exercises	60 days	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Self-reported Abstinence From Smoking	7 days	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)

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States