Smartband Mindfulness Study

NCT ID: NCT03995225

Last Updated: 2024-02-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-22

Study Completion Date

2022-03-03

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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Smartband automatic smoking detection combined with brief mindfulness interventions

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen A Garrison, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34783663 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R34AT010365-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000025082

Identifier Type: -

Identifier Source: org_study_id

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