Mechanisms of Mindfulness for Smoking Cessation

• 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: Brown University
• Collaborator: University of Massachusetts, Worcester
• Information provided by (Responsible Party): Judson Brewer, Brown University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Other
• Condition: Smoking Cessation
• Interventions: Behavioral: App/Training; Device: Smartphone
• Enrollment: 80

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Active Comparator App/Training	Experimental App/Training
Arm/Group Description	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	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
Period Title: Overall Study
Started	41	39
Completed	34	34
Not Completed	7	5

Baseline Characteristics

Arm/Group Title		Active Comparator App/Training	Experimental App/Training	Total
Arm/Group Description		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	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	Total of all reporting groups
Overall Number of Baseline Participants		34	33	67
Baseline Analysis Population Description		1 individual was excluded from analysis in the experimental app/training arm because they did not meet MRI inclusion criteria at follow-up
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	33 participants	67 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	34 100.0%	33 100.0%	67 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	34 participants	33 participants	67 participants
		43 (11)	46 (11)	45 (11)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	33 participants	67 participants
	Female	25 73.5%	20 60.6%	45 67.2%
	Male	9 26.5%	13 39.4%	22 32.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	33 participants	67 participants
	Hispanic or Latino	2 5.9%	2 6.1%	4 6.0%
	Not Hispanic or Latino	32 94.1%	31 93.9%	63 94.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	33 participants	67 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	1 3.0%	1 1.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	33 97.1%	31 93.9%	64 95.5%
	More than one race	1 2.9%	0 0.0%	1 1.5%
	Unknown or Not Reported	0 0.0%	1 3.0%	1 1.5%
PCC reactivity [1]; Mean (Standard Deviation); Unit of measure: BOLD signal
	Number Analyzed	34 participants	33 participants	67 participants
		18.9 (22.2)	22.2 (21.6)	20.5 (22)
		[1] Measure Description: Smoking cue reactivity in the posterior cingulate cortex (PCC) as measured by blood oxygen-level dependent (BOLD) response

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal
Description	BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator App/Training	Experimental App/Training
Arm/Group Description:	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	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
Overall Number of Participants Analyzed	34	33
Mean (Standard Deviation); Unit of Measure: BOLD signal
	16.1 (23.4)	18.6 (22.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator App/Training, Experimental App/Training
	Comments	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.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.92
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	1 month
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Active Comparator App/Training	Experimental App/Training
Arm/Group Description	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	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
All-Cause Mortality
	Active Comparator App/Training	Experimental App/Training
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/34 (0.00%)	0/33 (0.00%)
Serious Adverse Events
	Active Comparator App/Training	Experimental App/Training
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/34 (2.94%)	0/33 (0.00%)
Cardiac disorders
Prolapse of the mitral and tricuspid valves †	1/34 (2.94%)	0/33 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Active Comparator App/Training	Experimental App/Training
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/34 (2.94%)	2/33 (6.06%)
Ear and labyrinth disorders
Ear infection †	0/34 (0.00%)	1/33 (3.03%)
Musculoskeletal and connective tissue disorders
Back injury †	0/34 (0.00%)	1/33 (3.03%)
Respiratory, thoracic and mediastinal disorders
Sinusitis †	1/34 (2.94%)	0/33 (0.00%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

There are several limitations, including the short duration of follow up for smoking outcomes and the specific focus on a single region of interest.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Judson Brewer
• Organization: Brown University
• Phone: 401-863-2826
• EMail: judson_brewer@brown.edu

• Responsible Party: Judson Brewer, Brown University
• ClinicalTrials.gov Identifier: NCT02943499
• Other Study ID Numbers: 1R61AT009337-01 ( U.S. NIH Grant/Contract )
• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Results First Submitted: October 22, 2019
• Results First Posted: November 12, 2019
• Last Update Posted: November 19, 2019