Trial Outcomes & Findings for Study Two on the Effectiveness of Mindfulness Training for Smokers (NCT NCT01299909)
NCT ID: NCT01299909
Last Updated: 2019-06-27
Results Overview
Self-reported 7-day point-prevalence smoking abstinence (i.e., no smoking in the past 7 days) biochemically confirmed by carbon monoxide breath testing in MTS vs ITS subjects at 24 weeks post quit day.
COMPLETED
NA
175 participants
24 weeks post quit day
2019-06-27
Participant Flow
Participant milestones
| Measure |
Mindfulness Training for Smokers
MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
|
Integrated Training for Smokers
ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
|
Quitline
Non-Randomized, Treatment as Usual condition; participants self-selected to this group and received smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL).
|
|---|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
40
|
|
Overall Study
COMPLETED
|
46
|
49
|
23
|
|
Overall Study
NOT COMPLETED
|
22
|
18
|
17
|
Reasons for withdrawal
| Measure |
Mindfulness Training for Smokers
MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
|
Integrated Training for Smokers
ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
|
Quitline
Non-Randomized, Treatment as Usual condition; participants self-selected to this group and received smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
18
|
17
|
Baseline Characteristics
Study Two on the Effectiveness of Mindfulness Training for Smokers
Baseline characteristics by cohort
| Measure |
Mindfulness Training for Smokers
n=68 Participants
MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
|
Integrated Training for Smokers
n=67 Participants
ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
|
Quitline
n=40 Participants
Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
175 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
43.24 years
STANDARD_DEVIATION 12.05 • n=99 Participants
|
45.78 years
STANDARD_DEVIATION 13.35 • n=107 Participants
|
45.33 years
STANDARD_DEVIATION 11.89 • n=206 Participants
|
44.69 years
STANDARD_DEVIATION 12.51 • n=7 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
91 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=99 Participants
|
67 participants
n=107 Participants
|
40 participants
n=206 Participants
|
135 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 24 weeks post quit dayPopulation: analysis was conducted on all randomized participants
Self-reported 7-day point-prevalence smoking abstinence (i.e., no smoking in the past 7 days) biochemically confirmed by carbon monoxide breath testing in MTS vs ITS subjects at 24 weeks post quit day.
Outcome measures
| Measure |
Mindfulness Training for Smokers
n=68 Participants
MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
|
Integrated Training for Smokers
n=67 Participants
ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
|
|---|---|---|
|
Smoking Abstinence
|
17 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 24 weeks post-quitPopulation: Data are derived only from participants who completed all three study assessment visits
The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report questionnaire that assesses various components of mindfulness. Each item is rated on a 1 to 5 scale with 1=never or very rarely true and 5=very often or always true; responses are summed and then divided by 39 (the number of items). Higher scores on the FFMQ reflects a higher level of mindfulness (a better outcome). More information on the FFMQ is available in the following two articles: Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., \& Toney, L. (2006). Using self-report assessment methods to explore facets of mindfulness. Assessment, 13(1), 27-45, http://dx.doi.org/10.1177/1073191105283504. Baer,R. A., Smith,G. T., Lykins, E., Button,D., Krietemeyer, J., Sauer, S., et al. (2008). Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment, 15(3), 329-342, http://dx.doi.org/10.1177/1073191107313003.
Outcome measures
| Measure |
Mindfulness Training for Smokers
n=29 Participants
MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
|
Integrated Training for Smokers
n=30 Participants
ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire (FFMQ)
|
3.72 units on a scale
Standard Deviation 0.56
|
3.43 units on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 24 weeks post-quitPopulation: Data are derived only from participants who completed all three study assessment visits
The Acceptance and Action Questionnaire (AAQ) is a 9-item self-report measure of experiential avoidance. Each item is rated on a 1 to 7 scale with 1=Never true and 7=Always true; responses are summed and then divided by 9 (the number of items). The minimum score is 1 and the maximum score is 7. Higher scores equal greater levels of experiential avoidance or psychological inflexibility (a worse outcome). More information on the AAQ can be found in the following two articles: Hayes, S. C., Strosahl, K., Wilson, K. G., Bissett, R. T., Pistorello, J., Toarmino, D., et al. (2004). Measuring experiential avoidance: A preliminary test of a working model. The Psychological Record, 54(4), 553-578. Boelen, P. A., \& Reijntjes, A. (2008). Measuring experiential avoidance: Reliability and validity of the Dutch 9-item Acceptance and Action Questionnaire (AAQ). Journal of Psychopathology and Behavioral Assessment, 30, 241-251.
Outcome measures
| Measure |
Mindfulness Training for Smokers
n=29 Participants
MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
|
Integrated Training for Smokers
n=30 Participants
ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
|
|---|---|---|
|
Acceptance and Action Questionnaire (AAQ)
|
3.06 units on a scale
Standard Deviation 0.74
|
3.57 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 24 weeks post-quitPopulation: Data are derived only from participants who completed all three study assessment visits
The Perceived Stress Scale (PSS) is a self-report measure of perceived stress; the version used is a 10-item version. Each item is rated on a 0 to 4 scale with 0=Never and 4=Very Often. The minimum score is 0 and the maximum score is 40. Higher scores on the PSS reflect higher levels of perceived stress (a worse outcome). More information on the PSS can be found in the following article: Leung, D. Y., Lam, T. H., \& Chan, S. S. (2010). Three versions of Perceived Stress Scale: Validation in a sample of Chinese cardiac patients who smoke. BMC Public Health, 10, 513-519
Outcome measures
| Measure |
Mindfulness Training for Smokers
n=29 Participants
MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
|
Integrated Training for Smokers
n=30 Participants
ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
|
|---|---|---|
|
Perceived Stress Scale (PSS)
|
13.00 units on a scale
Standard Deviation 6.48
|
16.93 units on a scale
Standard Deviation 7.07
|
Adverse Events
Mindfulness Training for Smokers
Integrated Training for Smokers
Quitline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place