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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA022471-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Training for Smokers | Active Comparator | MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches. |
|
| Integrated Training for Smokers | Active Comparator | 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. |
|
| Quitline | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Training for Smokers | Behavioral | 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence | 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. | 24 weeks post quit day |
| Measure | Description | Time Frame |
|---|---|---|
| Five Facet Mindfulness Questionnaire (FFMQ) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James M Davis, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention | Madison | Wisconsin | 53711 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24957302 | Result | Davis JM, Manley AR, Goldberg SB, Smith SS, Jorenby DE. Randomized trial comparing mindfulness training for smokers to a matched control. J Subst Abuse Treat. 2014 Sep;47(3):213-21. doi: 10.1016/j.jsat.2014.04.005. Epub 2014 May 2. | |
| 35420700 | Derived | Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2. |
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Data will be available after June 2014 from Principal Investigator James Davis, MD, who is now at Duke University (james.m.davis@duke.edu).
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Data will be available after June 2014 from Principal Investigator James Davis, MD, who is now at Duke University (james.m.davis@duke.edu).
Other researchers will need to contact the Principal Investigator James Davis, MD, who is now at Duke University (james.m.davis@duke.edu).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This is based on enrollment - it was the number randomized. The Quitline group was a non-randomized, treatment as usual group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Abstinence | 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. | analysis was conducted on all randomized participants | Posted | Number | participants | 24 weeks post quit day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stevens S. Smith, Ph.D. | University of Wisconsin | 608-262-7563 | sss@ctri.wisc.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Mindfulness Training for Smokers | Behavioral | 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website. |
|
|
| Quitline | Behavioral | 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. |
|
|
| 24 weeks post-quit |
| Acceptance and Action Questionnaire (AAQ) | 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. | 24 weeks post-quit |
| Perceived Stress Scale (PSS) | 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 | 24 weeks post-quit |
| 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
|
|
| Secondary | Five Facet Mindfulness Questionnaire (FFMQ) | 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. | Data are derived only from participants who completed all three study assessment visits | Posted | Mean | Standard Deviation | units on a scale | 24 weeks post-quit |
|
|
|
|
| Secondary | Acceptance and Action Questionnaire (AAQ) | 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. | Data are derived only from participants who completed all three study assessment visits | Posted | Mean | Standard Deviation | units on a scale | 24 weeks post-quit |
|
|
|
|
| Secondary | Perceived Stress Scale (PSS) | 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 | Data are derived only from participants who completed all three study assessment visits | Posted | Mean | Standard Deviation | units on a scale | 24 weeks post-quit |
|
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | 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 | 0 | 67 | 0 | 67 |
| EG002 | 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. | 0 | 40 | 0 | 40 |
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| D015438 |
| Health Behavior |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D008722 | Methods |