Mobile Mindfulness Training for Smoking Cessation

Smoking Cessation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037360
• Other study ID #: 1305012015
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: January 26, 2018
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1251
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Active Comparator 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
• Experimental 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.

Locations

Country	Name	City	State
United States	University of Massachusetts, Worcester	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Point prevalence abstinence at 3 months	Subjects will be assessed for smoking abstinence at a 3-month follow-up.	3 months after beginning treatment

External Links

•   Click here for more information and to sign up for the study