Smartband Mindfulness Study

Sponsor

Yale University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03995225

Collaborator

(none)

110

Enrollment

Location

Arm

23.3

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: Smartband automatic smoking detection and brief mindfulness interventions	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 22, 2020

Actual Primary Completion Date :

Mar 3, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

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.	Behavioral: Smartband automatic smoking detection and brief mindfulness interventions Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions

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.

Behavioral: Smartband automatic smoking detection and brief mindfulness interventions

Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions

Outcome Measures

Primary Outcome Measures

Fidelity of detecting smoking episodes [21 days]
Percent of smoking episodes detected and the rate of false alarms in the first 21 days of the study during which smokers are wearing the smartband to monitor, detect and notify them of smoking episodes.
Fidelity of delivering mindfulness exercises triggered by smoking [7 days]
Percent of mindful smoking exercises correctly triggered by detected smoking episodes and the rate of false alarms in the next 7 days of the study 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).
Adherence to wearing the smartband [60 days]
Percent of time spent wearing the smartband
Adherence to answering smartband notifications of smoking events [60 days]
Percent of smoking notifications answered
Adherence to answering ecological momentary assessment items [60 days]
Percent of ecological momentary assessment (EMA) ratings (e.g., timeliness, helpfulness, craving, affect) answered.
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.
Acceptability of intervention - user experiences survey [60 days]
Feedback on user experiences survey (e.g., whether there were too many or not enough interventions) - One survey

Secondary Outcome Measures

Self-reported abstinence from smoking [7 days]
As a secondary aim we will also evaluate self-reported one-week point prevalence abstinence from smoking.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale School of Medicine	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Kathleen A Garrison, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT03995225

Other Study ID Numbers:

2000025082

First Posted:

Jun 21, 2019

Last Update Posted:

Jun 6, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 6, 2022