Smartband Mindfulness Study

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

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Smartband automatic smoking detection combined with brief mindfulness interventions

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 Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smokers; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Kathleen A Garrison, PhD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2020
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): March 3, 2022

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2000025082; 1R34AT010365-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No