Mechanisms of Mindfulness for Smoking Cessation

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

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Device: Smartphone; Behavioral: App/Training; Behavioral: App/Training

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts, Worcester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Smartphone; Behavioral: 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; 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.
Experimental: 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.	Device: Smartphone; Behavioral: 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 10, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1R61AT009337-01 (U.S. NIH Grant/Contract)