Mechanisms of Mindfulness for Smoking Cessation

Study Overview
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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.

Official Title
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Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: App/Training
* Behavioral: App/Training
* Device: Smartphone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator App/Training<br>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. | Behavioral: App/Training<br>* 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<br>Device: Smartphone<br> <br> |
| Experimental: Experimental App/Training<br>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. | Behavioral: App/Training<br>* 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.<br>Device: Smartphone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal | BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping | 1 month |