Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brown University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal
Study Overview
Brief Summary
The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: App/Training (Behavioral)
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.
Intervention: Smartphone (Device)
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.
Intervention: App/Training (Behavioral)
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.
Intervention: Smartphone (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Judson Brewer
Principal Investigator
Brown University