MTS2: Study Two on the Effectiveness of Mindfulness Training for Smokers

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT01299909
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 175
• Location: 1
• Arms: 3
• Duration (Months): 33.1
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The study design includes two randomized arms to compare matched intensive interventions and a third non-randomized option for participants who prefer not to enter an intensive intervention. It is expected that roughly 50% (120) will choose to be in the randomized intensive interventions and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes over a 6-week period and 2 weeks of nicotine patches. MTS provides and training in mindfulness whereas ITS provides training in quit smoking strategies and access to the Freedom From Smoking Online Premium Program. Participants who choose to be in a non-intensive intervention (estimated from prior recruitment data at n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine patches.

Condition or Disease	Intervention/Treatment	Phase
Nicotine Dependence	Behavioral: Integrated Training for Smokers; Behavioral: Mindfulness Training for Smokers; Behavioral: Quitline	N/A

Detailed Description

The MTS2 Study is funded for through a five-year K23 NIH training grant (appendix) awarded to Dr. James Davis, the Principal Investigator on this protocol. The study enrollment goal is N=240 adult smokers randomized to study treatments. Based on prior recruitment numbers, it is expected that roughly 50% (120) will choose to be in an intensive intervention and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either MTS (n = 60) or ITS (n=60). MTS is a smoking cessation intervention that provides 8 mindfulness classes over a 6-week period. ITS will provide participants will access to the Freedom From Smoking Online Premium Program (at no cost) plus 8 smoking cessation classes over a 6-week period. Participants who choose to be in a non-intensive intervention (n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line. At the Orientation Meeting, participants who decide to enter the study will be allowed to choose whether they enter an intensive or the non-intensive intervention. Intensive intervention participants will attend an additional meeting called the Introductory Meeting where they are will undergo randomization into either the MTS or ITS. The Introductory Meeting will also provide instruction on the use of nicotine patches, smoking calendars and provide intervention materials. The study employs 3 study assessment visits. Study Visit 1 follows the Orientation Meeting, Study Visit 2 is 4-weeks post-quit, Study Visit 3 is 24-weeks post-quit. All participants will receive 2 weeks of free nicotine patches and $30 for attending each of the two post-quit study visits.

The total time for the study including recruitment, intervention and participant follow-up for N = 240 will be three years. The study will recruit subjects from the Dane county region through the University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention (UW-CRTI). Recruitment will take place through flyers, television, newspaper and radio advertisements.

The principal hypothesis for the study is that MTS compared to ITS will show significantly higher point prevalent Carbon Monoxide confirmed smoking abstinence rates at 4 and 24 weeks post quit. Secondary hypotheses is that study group compared to controls will show significant differences in questionnaire results that test distress, depression, anxiety, attentional control, mindfulness and quality of life and bio-physiological markers such as weight, breath holding and hair cortisol.

Study Design

• Study Type: Interventional
• Actual Enrollment: 175 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study Two for Development of Novel Behavioral Intervention Mindfulness Training for Smokers
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Mindfulness Training for Smokers; 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.; Other Names: Study Group MTS
Active Comparator: 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.	Behavioral: Integrated Training for Smokers; 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program; Other Names: Control Group ITS
Other: Quitline Quitline participants will consist of participants who elect not to participate in the high-intensity treatments (Mindfulness Training for Smokers; Integrated Training for Smokers. This Quitline group is a Non-Randomized, Treatment as Usual group.	Behavioral: Quitline; 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.; Other Names: Non-Randomized, Treatment as Usual

Outcome Measures

Primary Outcome Measures

1. Smoking Abstinence [24 weeks post quit day]

   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.

Secondary Outcome Measures

1. Five Facet Mindfulness Questionnaire (FFMQ) [24 weeks post-quit]

   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.

2. Acceptance and Action Questionnaire (AAQ) [24 weeks post-quit]

   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.

3. Perceived Stress Scale (PSS) [24 weeks post-quit]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age: 18 years or over;

• Participants must express "high" motivation to quit smoking

• Participants must express willingness to attend "all" meetings for 2 months

• Smoke 5 or more cigarettes per day

Exclusion Criteria:

• Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.

• Self report of using chewing tobacco, snuff or cigars in the last week.

• High score on Patient Health Questionnaire Depression Screening Tool for severe depression and suicidal intention.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention	Madison	Wisconsin	United States	53711

Sponsors and Collaborators

• University of Wisconsin, Madison
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: James M Davis, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01299909
• Other Study ID Numbers: 2011-0087; 1K23DA022471-01A1
• First Posted: Feb 18, 2011
• Last Update Posted: Jun 27, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by University of Wisconsin, Madison: Mindfulness Training for Smokers; Smoking; Smoking cessation; Addiction; behavioral intervention; Nicotine; Tobacco; Mindfulness; Meditation; MBSR; Mindfulness Based Stress Reduction; Mindfulness Based Cognitive Therapy; MBCT; Mindfulness Based Relapse Prevention; MBRP; Mindfulness Training; Nicotine Patch; Quit Line; Phone counseling; Freedom from Smoking
• Additional relevant MeSH terms: Tobacco Use Disorder

Study Results

Participant Flow

Arm/Group Title	Mindfulness Training for Smokers	Integrated Training for Smokers	Quitline
Arm/Group Description	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.	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	Non-Randomized, Treatment as Usual condition; participants self-selected to this group and received smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL).
Period Title: Overall Study
STARTED	68	67	40
COMPLETED	46	49	23
NOT COMPLETED	22	18	17

Baseline Characteristics

Arm/Group Title	Mindfulness Training for Smokers	Integrated Training for Smokers	Quitline	Total
Arm/Group Description	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.	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	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 of all reporting groups
Overall Participants	68	67	40	175
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	68 100%	67 100%	40 100%	175 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.24 (12.05)	45.78 (13.35)	45.33 (11.89)	44.69 (12.51)
Sex: Female, Male (Count of Participants)
Female	29 42.6%	34 50.7%	21 52.5%	84 48%
Male	39 57.4%	33 49.3%	19 47.5%	91 52%
Region of Enrollment (participants) [Number]
United States	68 100%	67 100%	40 100%	135 77.1%

Outcome Measures

1. Primary Outcome

Title	Smoking Abstinence
Description	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.
Time Frame	24 weeks post quit day

Outcome Measure Data

Analysis Population Description

analysis was conducted on all randomized participants

Arm/Group Title	Mindfulness Training for Smokers	Integrated Training for Smokers
Arm/Group Description	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.	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
Measure Participants	68	67
Number [participants]	17 25%	12 17.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mindfulness Training for Smokers, Integrated Training for Smokers
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.35
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.53
	Confidence Interval	(2-Sided) 95%; 0.67 to 3.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Five Facet Mindfulness Questionnaire (FFMQ)
Description	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.
Time Frame	24 weeks post-quit

Outcome Measure Data

Analysis Population Description

Data are derived only from participants who completed all three study assessment visits

Arm/Group Title	Mindfulness Training for Smokers	Integrated Training for Smokers
Arm/Group Description	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.	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
Measure Participants	29	30
Mean (Standard Deviation) [units on a scale]	3.72 (0.56)	3.43 (0.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mindfulness Training for Smokers, Integrated Training for Smokers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	ANOVA
	Comments	df=(1,57)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.81
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Acceptance and Action Questionnaire (AAQ)
Description	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.
Time Frame	24 weeks post-quit

Outcome Measure Data

Analysis Population Description

Data are derived only from participants who completed all three study assessment visits

Arm/Group Title	Mindfulness Training for Smokers	Integrated Training for Smokers
Arm/Group Description	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.	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
Measure Participants	29	30
Mean (Standard Deviation) [units on a scale]	3.06 (0.74)	3.57 (0.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mindfulness Training for Smokers, Integrated Training for Smokers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments	df=(1,57)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.09
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Perceived Stress Scale (PSS)
Description	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
Time Frame	24 weeks post-quit

Outcome Measure Data

Analysis Population Description

Data are derived only from participants who completed all three study assessment visits

Arm/Group Title	Mindfulness Training for Smokers	Integrated Training for Smokers
Arm/Group Description	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.	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
Measure Participants	29	30
Mean (Standard Deviation) [units on a scale]	13.00 (6.48)	16.93 (7.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mindfulness Training for Smokers, Integrated Training for Smokers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	ANOVA
	Comments	df=(1,57)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.96
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Mindfulness Training for Smokers		Integrated Training for Smokers		Quitline
Arm/Group Description	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.		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		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.
All Cause Mortality
	Mindfulness Training for Smokers		Integrated Training for Smokers		Quitline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Mindfulness Training for Smokers		Integrated Training for Smokers		Quitline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/67 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Mindfulness Training for Smokers		Integrated Training for Smokers		Quitline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/67 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.