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Mechanisms of Mindfulness for Smoking Cessation

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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

Tracking Information
First Submitted Date  ICMJE October 21, 2016
First Posted Date  ICMJE October 24, 2016
Results First Submitted Date  ICMJE October 22, 2019
Results First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 19, 2019
Study Start Date  ICMJE October 2016
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2016)
Changes in brain activity after app-based mindfulness training [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanisms of Mindfulness for Smoking Cessation
Official Title  ICMJE Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.
Brief Summary The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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.
  • Device: Smartphone
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: App/Training
    • 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.
    Interventions:
    • Behavioral: App/Training
    • Device: Smartphone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2019)
80
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2016)
260
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02943499
Other Study ID Numbers  ICMJE 1R61AT009337-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Judson Brewer, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE University of Massachusetts, Worcester
Investigators  ICMJE Not Provided
PRS Account Brown University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP