Study Results
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View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2017-01-18
2017-10-03
Brief Summary
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Detailed Description
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All participants will receive in-person group treatment based on the 8-week MBAT protocol in addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit Mindfully will receive additional support via text messaging. Assessments will occur at baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco dependence and psychological well-being will be assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mindfulness-based Addiction Treatment (MBAT)
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-Help guide
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).
Nicotine Patch
Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
iQuit Mindfully
Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully
iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).
Nicotine Patch
Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
Interventions
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Mindfulness-based Addiction Treatment
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully
iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).
Nicotine Patch
Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* current smoker with history of \>5 cigarettes/day for past year (and expired carbon monoxide \>6 parts per million \[ppm\])
* motivated to quit within next 30 days
* valid home address in the greater Atlanta, Georgia area
* functioning telephone number
* own a mobile phone with text messaging capacity
* can speak, read, and write in English
* at least a sixth-grade level of health literacy
Exclusion Criteria
* active substance abuse/dependence
* regular use of tobacco products other than cigarettes
* current use of tobacco cessation medications
* pregnancy or lactation
* household member enrolled in the study
* current diagnosis of schizophrenia or bipolar disorder, or use of antipsychotic medications
* clinically significant depressive symptoms
18 Years
65 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Utah
OTHER
The Catholic University of America
OTHER
George Washington University
OTHER
University of Chicago
OTHER
Georgia State University
OTHER
Responsible Party
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Claire Spears
Assistant Professor
Principal Investigators
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Claire A Spears, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Georgia State University
Locations
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Georgia State University
Atlanta, Georgia, United States
Countries
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References
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Vidrine JI, Spears CA, Heppner WL, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness-based addiction treatment (MBAT) for smoking cessation and lapse recovery: A randomized clinical trial. J Consult Clin Psychol. 2016 Sep;84(9):824-838. doi: 10.1037/ccp0000117.
Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
Spears CA, Abroms LC, Glass CR, Hedeker D, Eriksen MP, Cottrell-Daniels C, Tran BQ, Wetter DW. Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 24;7(6):e13059. doi: 10.2196/13059.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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