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Mechanisms of Mindfulness for Smoking Cessation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02943499
Enrollment
80
Registered
2016-10-24
Start date
2016-10-31
Completion date
2018-08-31
Last updated
2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

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

BEHAVIORALApp/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

DEVICESmartphone

Sponsors

University of Massachusetts, Worcester
CollaboratorOTHER
Brown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal1 monthBOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total67

Baseline characteristics

CharacteristicActive Comparator App/TrainingExperimental App/TrainingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
34 Participants33 Participants67 Participants
Age, Continuous43 years
STANDARD_DEVIATION 11
46 years
STANDARD_DEVIATION 11
45 years
STANDARD_DEVIATION 11
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants31 Participants63 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
PCC reactivity18.9 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 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
33 Participants31 Participants64 Participants
Sex: Female, Male
Female
25 Participants20 Participants45 Participants
Sex: Female, Male
Male
9 Participants13 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 33
other
Total, other adverse events
1 / 342 / 33
serious
Total, serious adverse events
1 / 340 / 33

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Active Comparator App/TrainingChange From Baseline in Blood Oxygen Level Dependent (BOLD) Signal16.1 BOLD signalStandard Deviation 23.4
Experimental App/TrainingChange From Baseline in Blood Oxygen Level Dependent (BOLD) Signal18.6 BOLD signalStandard Deviation 22.2
Comparison: To examine between-group differences in pre- vs. post-treatment cue reactivity, the post-treatment PCC BOLD response for the smoking vs neutral contrast was subtracted from the baseline response. The groups were then compared directly on this measure using a t-test.p-value: 0.92t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026