Smartband Mindfulness Study

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995225
• Other study ID #: 2000025082
• Secondary ID: 1R34AT010365-01
• Status: Completed
• Phase: N/A
• Start date: November 22, 2020
• Est. completion date: March 3, 2022

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: March 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Adherence to Wearing the Smartband	Percent of days spent wearing the smartband.	60 days
Primary	Adherence to Answering Smartband Notifications of Smoking Events	Percent of smoking notifications answered	60 days
Primary	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
Primary	Adherence to Completing Mindfulness Exercises	Percent of mindfulness exercises (RAIN, mindful smoking) completed	60 days
Primary	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
Primary	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	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