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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

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Comparator App/Training Experimental App/Training
Hide 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
Arm/Group Title Active Comparator App/Training Experimental App/Training Total
Hide 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
Hide 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
1.Primary Outcome
Title Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal
Hide Description BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator App/Training Experimental App/Training
Hide 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)
Hide 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]
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Comparator App/Training Experimental App/Training
Hide 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%) 
Hide 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
Hide 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
There are several limitations, including the short duration of follow up for smoking outcomes and the specific focus on a single region of interest.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Judson Brewer
Organization: Brown University
Phone: 401-863-2826
EMail: judson_brewer@brown.edu
Layout table for additonal information
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