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Mechanisms of Mindfulness for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02943499
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : November 12, 2019
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Judson Brewer, Brown University

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: App/Training Device: Smartphone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.
Study Start Date : October 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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

Device: Smartphone
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.
 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.

Device: Smartphone


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal [ Time Frame: 1 month ]
    BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943499


Locations
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United States, Massachusetts
University of Massachusetts, Worcester
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Brown University
University of Massachusetts, Worcester
  Study Documents (Full-Text)

Documents provided by Judson Brewer, Brown University:
Study Protocol and Statistical Analysis Plan  [PDF] December 6, 2018

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Judson Brewer, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT02943499    
Other Study ID Numbers: 1R61AT009337-01 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2016    Key Record Dates
Results First Posted: November 12, 2019
Last Update Posted: November 19, 2019
Last Verified: November 2019