Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
Condition: Nicotine Addiction; Serious Mental Illness
MeSH terms: Tobacco Use Disorder; Mental Disorders
Intervention: Learn to Quit App; Nicotine patch; Nicotine lozenge; Technical Coaching; NCI QuitGuide App
Intervention description: A smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods.; Participants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.; Each participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.; Coaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (~15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance.; A smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies).
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be assigned to one of two smoking cessation apps for the duration of the study: Learn to Quit or NCI QuitGuide. One app was designed to address the needs of people with serious mental illness (Learn to Quit) and the other was designed for the general population (NCI QuitGuide).
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking; mHealth; Serious Mental Illness; Acceptance and Commitment Therapy; US DHHS Clinical Practice Guidelines

Summary:

      Quitting smoking has important health benefits for people with serious mental illness, more
      than half of whom are smokers. Smoking reductions in this population, in turn, could
      contribute to saving billions of dollars in healthcare expenditures.

      Finding ways to deliver more effective and wider reaching smoking cessation interventions to
      individuals with serious mental illness is a pressing priority. Smartphone apps are a wide
      reaching technology that could provide a viable platform to deliver smoking cessation
      interventions for individuals with serious mental illness.

      However, do smoking cessation apps need to be tailored for people with serious mental illness
      to ensure their success? Or can providers simply use standard and freely available smoking
      cessation mobile health treatments designed for the general population? Furthermore, is it
      feasible to conduct mHealth trials in this population?

      Therefore, this trial will test whether (1) a tailored smoking cessation app for people with
      serious mental illness results in higher levels of engagement with smoking cessation content
      as compared to an app designed for the general population and (2) smoking cessation mHealth
      trials can be feasibly conducted in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ICD-10 diagnosis of schizophrenia, schizoaffective, bipolar or recurring depressive
             disorder

          -  Smoking ≥ 5 cigarettes per day over the past 30 days

          -  Desire to quit smoking in the next 30 days

          -  Willing and medically eligible to use Nicotine Replacement Therapy

          -  Fluent in spoken and written English

          -  Working email, mailing address, or alternative contact person

          -  Taking psychiatric medications as prescribed by their provider

          -  Stable housing

        Exclusion Criteria:

          -  Problematic alcohol or illicit drug use in the last 30 days

          -  Acute psychotic episode, unsafe to participate in the study, or psychiatrically
             unstable

          -  Pregnant, breastfeeding, or having the intention to become pregnant in the next 4
             months

          -  Hearing, comprehension, or visual limitations that preclude study participation

          -  Currently receiving any pharmacological and/or behavioral intervention or counseling
             for smoking cessation

          -  Using non-cigarette forms of tobacco as the primary source of nicotine (e.g.
             e-cigarettes, chew)