Smoking Cessation
Conditions
Brief summary
The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.
Interventions
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
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal | 1 month | BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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
Smartphone | 34 |
| 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.
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.
Smartphone | 33 |
| Total | 67 |
Baseline characteristics
| Characteristic | Active Comparator App/Training | Experimental App/Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 33 Participants | 67 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 11 | 46 years STANDARD_DEVIATION 11 | 45 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 31 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PCC reactivity | 18.9 BOLD signal STANDARD_DEVIATION 22.2 | 22.2 BOLD signal STANDARD_DEVIATION 21.6 | 20.5 BOLD signal STANDARD_DEVIATION 22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 33 Participants | 31 Participants | 64 Participants |
| Sex: Female, Male Female | 25 Participants | 20 Participants | 45 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 |
| other Total, other adverse events | 1 / 34 | 2 / 33 |
| serious Total, serious adverse events | 1 / 34 | 0 / 33 |
Outcome results
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal
BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator App/Training | Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal | 16.1 BOLD signal | Standard Deviation 23.4 |
| Experimental App/Training | Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal | 18.6 BOLD signal | Standard Deviation 22.2 |