Mobile Mindfulness Training for Smoking Cessation

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training smartphone application on smoking cessation in smokers ages 18 to 65 years.

Detailed Description
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In this study, a pilot phase will be carried out first to test feasibility and engagement of the tested intervention. Then in the randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains mindfulness for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Active Comparator App/Training
* Behavioral: Experimental App/Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be (a) 18-65 years of age; (b) smoke 5+ cigarettes/day, (c) < 3 months abstinence in the past year; (d) have a smartphone; and motivated to quit smoking. Exclusion Criteria: There are no exclusion criteria. We aim to recruit a heterogeneous group, representative of the general population.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
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: Active Comparator 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>|
| 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: Experimental 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point prevalence abstinence at 6 months | Subjects will be assessed for smoking abstinence at a 6-month follow-up. | 6 months after beginning treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point prevalence abstinence at 3 months | Subjects will be assessed for smoking abstinence at a 3-month follow-up. | 3 months after beginning treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Cessation