Study Two on the Effectiveness of Mindfulness Training for Smokers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study Two for Development of Novel Behavioral Intervention Mindfulness Training for Smokers

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Behavioral: Integrated Training for Smokers
* Behavioral: Mindfulness Training for Smokers
* Behavioral: Quitline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness Training for Smokers<br>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<br>* 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.<br>* Other names: MTS;|
| Active Comparator: Integrated Training for Smokers<br>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<br>* 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program<br>* Other names: ITS;|
| Other: Quitline<br>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<br>* 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.<br>* Other names: Non-Randomized, Treatment as Usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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