Mobile Mindfulness Training for Smoking Cessation

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Active Comparator App/Training; Behavioral: Experimental App/Training

• Registration Number: NCT02037360
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Study Start: 2015-08
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1251

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator App/Training	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.
Experimental App/Training	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.

Primary Outcome Measures

Name	Time	Method
Point prevalence abstinence at 6 months	6 months after beginning treatment	Subjects will be assessed for smoking abstinence at a 6-month follow-up.

Secondary Outcome Measures

Name	Time	Method
Point prevalence abstinence at 3 months	3 months after beginning treatment	Subjects will be assessed for smoking abstinence at a 3-month follow-up.

Trial Locations

Locations (1)

University of Massachusetts, Worcester; 🇺🇸 Worcester, Massachusetts, United States