Mechanisms of Mindfulness for Smoking Cessation

NCT ID: NCT02943499

Last Updated: 2019-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-08-31

Brief Summary

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The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Active Comparator App/Training

This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.

Group Type ACTIVE_COMPARATOR

App/Training

Intervention Type BEHAVIORAL

This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones

Smartphone

Intervention Type DEVICE

Experimental App/Training

This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.

Group Type EXPERIMENTAL

App/Training

Intervention Type BEHAVIORAL

It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.

Smartphone

Intervention Type DEVICE

Interventions

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App/Training

This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones

Intervention Type BEHAVIORAL

App/Training

It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.

Intervention Type BEHAVIORAL

Smartphone

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 21-65 years of age
* Smoke 10+ cigarettes/day
* \< 3 months abstinence in the past year
* Have a smartphone; and motivated to quit smoking
* Score \>18 of 20 on Action subscale of the Readiness to Change Questionnaire

Exclusion Criteria

* Any usage of psychotropic medication: not on a stable dosage 6+ months
* Prior participation in a mindfulness course or regular meditation practice (\>20 min/week)
* Serious psychiatric, cognitive, or medical disorder
* MRI contraindications
* Structural brain damage as well as other brain abnormalities revealed by the MRI
* Claustrophobia
* Not being fluent in English
* Recreational drug use
* Pregnant women
* History of a neurological disorder
* Current participation in a smoking study
* Adults unable to consent
* Prisoners
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Judson Brewer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Massachusetts, Worcester

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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1R61AT009337-01

Identifier Type: NIH

Identifier Source: org_study_id

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