Trial on the Effectiveness of Mindfulness Training for Smokers (MTS)
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|ClinicalTrials.gov Identifier: NCT01093599|
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : February 16, 2015
Last Update Posted : October 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Behavioral: Quit Line plus MTS Behavioral: Quit Line Only||Not Applicable|
The MTS study is funded for through a five year K23 NIH training grant. The study follows a randomized controlled design with N = 240. Both the study group and the control group will be enrolled in the Wisconsin Tobacco Quit Line, will receive four weeks of nicotine patches, and receive phone based counseling through the Quit Line. The control group n = 120 will receive the Quit Line intervention alone where as the study group n = 120 will receive the Quit Line intervention plus the Mindfulness Training for Smokers (MTS) Intervention.
Mindfulness Training for Smokers provides 4 weeks of mindfulness meditation instruction followed by entry into a MTS meditation group. The total time for the study including recruitment, intervention and participant follow-up for N = 240 will be four 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 the television and radio advertisements (appendix). In addition, the Wisconsin Quit Line web site will provide a link to the MTS study. With this link, quit line coaches will have a brief description of the study (see appendix) and will provide contact information for the study. Finally, the MTS web site (url: www.sittoquit.org) will provide basic introductory information available to the general public.
The principal hypothesis for the study is that MTS plus Quit Line will lead to significantly higher rates of smoking cessation at 6 months than use of the Quit Line alone. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Randomized Trial on the Effectiveness of Mindfulness Training for Smokers, a Novel Intervention Designed to Help Smokers Quit Smoking|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: Quit Line Only
Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Behavioral: Quit Line Only
The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Other Name: Control Group
Active Comparator: Quit Line plus MTS
Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.
Behavioral: Quit Line plus MTS
This provides the quit line intervention plus the Mindfulness for Smokers Intervention.
- Smoking Abstinence [ Time Frame: 6 months post quit day ]Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.
- Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls [ Time Frame: 6 months post quit day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093599
|United States, Wisconsin|
|University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention|
|Madison, Wisconsin, United States, 53711|
|Principal Investigator:||James M Davis, MD||University of Wisconsin, Madison|