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

University of Utah
The Catholic University of America
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
        Not specified
        Atlanta, Georgia, United States, 30303
      Status:
      completed
      Type:
      Interventional
      Phase:
      -
      Start:
      17 January, 2017
      Updated:
      16 October, 2017
      Participants:
      72
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