A Mindfulness Based Application for Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Cigarette smoking is the leading cause of preventable death and disability in the world.
      Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually.
      Additional effective, safe, and accessible treatments for nicotine dependence are needed due
      to the low abstinence rates (20-30%) achieved in behavioral therapies, the unappealing side
      effects of pharmacotherapy, and the frequent lack of accessibility to treatment. Recent
      evidence supports the central role of craving in maintaining nicotine dependence, and neither
      behavioral nor replacement therapies directly target the relationship between cravings and
      smoking. Mindfulness therapy has been found to be effective in teaching strategies to
      decouple the association between craving and smoking. Mindfulness based smoking therapy (MT)
      has preliminary support for reducing consumption in smokers, and Dr. Judson Brewer has
      recently translated this program into a mobile device application (app) for smoking
      cessation. With Dr. Brewer's consultation, we propose to assess the feasibility of
      implementation of a MT mobile application in local hospital and community clinics and the
      effectiveness of the MT mobile application compared to a National Cancer Institute (NCI)
      QuitPal behavioral change group. We will examine smoking results at end of treatment and 2
      and 6 month follow-up as well as the role of craving. If MT smoking cessation is determined
      to be effective in a mobile phone application, this finding will be a significant step in
      providing an additional effective and safe treatment for smokers wishing to quit or cut down
      on their intake, and will be especially important in providing treatment options for
      marginalized or hard-to-access individuals wishing to reduce cigarette intake.
    

Detailed description: 
      Cigarette smoking is the leading cause of preventable death and disability in the world,
      accounting for 10% of all deaths. In the US, smoking costs more than $193 billion in health
      care costs and lost productivity per year. Although over 70% of smokers want to quit, fewer
      than 5% achieve this goal annually. Mainstay behavioral treatments for smoking have focused
      on teaching individuals to avoid cues, foster positive affective states, develop lifestyle
      changes that reduce stress, divert attention from cravings, substitute other activities for
      smoking, learn cognitive strategies that reduce negative mood and develop social support
      mechanisms. These have shown modest success, with abstinence rates between only 20-30% over
      the past thirty years. This is presumably due to the complex nature of the acquisition and
      maintenance of nicotine addiction, including associative learning mechanisms as well as
      positive and negative reinforcement. Over time, cues that are judged to be positive or
      negative can induce affective states, which can then trigger a craving to smoke. Though the
      centrality of craving remains controversial, evidence suggests that craving is strongly
      associated with smoking, which, mainly through the physiological properties of nicotine,
      results in the maintenance or improvement of positive or reduction of negative affective
      states. This sets up reinforcement loops by reinforcing memories between affect and smoking.
      Thus, attention has been focused on additional strategies to help people tolerate negative
      affect and cravings rather than avoiding cues or substituting activities, and recent research
      suggest that MT may decouple the association between craving and smoking, thus facilitating
      smoking cessation.

      Mindfulness training (MT) targets affective or craving states by teaching individuals to
      observe aversive body and mind states instead of reacting to them with habitual reactions,
      thus allowing more adaptive, healthier responses. Mindfulness training (MT) has shown promise
      in reducing anxiety and depression and has recently been explored in the treatment of
      addictions. In a 2011 randomized controlled trial by Brewer, et al., individuals who received
      an 8- session MT vs. the American Lung Association's 8 session freedom from smoking (FFS)
      treatment, showed significantly greater rate of reduction in cigarette use and greater point
      prevalence abstinence rates during treatment and maintained these gains during follow up. FFS
      is a behavior modification program and includes stress reduction and relapse prevention.
      Although both treatment groups were assigned home practice as part of their treatment, only
      those who received mindfulness training demonstrated a significant association between home
      practice and smoking outcomes, suggesting that there was a specific benefit to mindfulness
      practice and that positive treatment outcomes for those in this group are not merely a result
      of greater enthusiasm or interest in quitting. The ability of MT to attenuate the
      relationship between craving and substance use has been observed in other studies as well.
      Elwafi, et al. (2012) demonstrated that people who practiced mindfulness more smoked less,
      regardless of their level of craving. Practicing mindfulness appears critical to MT treatment
      outcomes. These results suggest that MT may help individuals develop a tolerance to craving
      itself, thus over time acting to dismantle the addictive loop. To date, research in this area
      has been conducted in randomized clinical trials in structured laboratory settings only.
      Important next steps are to examine the effectiveness of MT treatments for smoking cessation
      in naturalistic environments and to utilize methods of delivering treatment in real world
      settings that will facilitate compliance with mindfulness practice and thus improve treatment
      outcomes - for example, via a mobile device application. Additionally, trials comparing MT to
      alternative treatment approaches typically offered in outpatient clinics such as support
      groups, acupuncture, individual counseling, or nicotine replacement therapies are lacking.
      Mindfulness based (MT) smoking cessation has been adapted to a mobile device application
      called "Craving to Quit" based on the work done by Brewer and will be the mindfulness
      intervention used in this study. Standardization and implementation via a mobile application
      is a logical and necessary next step in the dissemination of treatment and will potentially
      provide access to an effective smoking cessation program for persons who may not otherwise be
      able to access treatment.
    

Intervention name(s): Mindfulness based smoking cessation; Behavioral Smoking Cessation intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness based interventions are provided via a mobile phone application.; Behavioral Smoking Cessation intervention is a behaviorally based intervention is provided via a mobile phone application.
Other intervention name(s): Craving to Quit; Behavioral therapy; Cognitive Behavioral therapy; NCI QuitPal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking cessation; mindfulness; behavioral intervention