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iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology (NCT03029819)

University of Utah
National Center for Complementary and Integrative Health (NCCIH)
The Catholic University of America
George Washington University
University of Chicago
The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.
  • Behavioral: 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).
    • Behavioral: 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.
      • Mindfulness-based text messaging for smoking cessation
    • Behavioral: Self-Help guide
      Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
      • Drug: 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.
        • Generic Nicotine Patch
      Ages eligible for Study
      18 Years to 65 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • age 18-65 years
      • 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:
      • contraindication for nicotine patch
      • 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
      This study is a pilot investigation of mindfulness-based smoking cessation treatment incorporating between-session text messaging ("iQuit Mindfully"). Participants will be randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit Mindfully (MBAT with the addition of between-session text messages).

      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.

      1 locations

      United States (1)
      • Georgia State University
        recruiting
        Atlanta, Georgia, United States, 30303
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      31 December, 2016
      Updated:
      19 January, 2017
      Participants:
      70
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