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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

175 participants

Primary outcome timeframe

24 weeks post quit day

Results posted on

2019-06-27

Participant Flow

Participant milestones

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

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

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 day

Population: 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

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-quit

Population: 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

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-quit

Population: 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

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-quit

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Integrated Training for Smokers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Quitline

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stevens S. Smith, Ph.D.

University of Wisconsin

Phone: 608-262-7563

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place