Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

Study Overview
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Brief Summary
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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.

Detailed Description
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Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to $317 billion expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide reaching technology that could provide individuals with serious mental illness the necessary skills for quitting. This feasibility trial will test whether a tailored smoking cessation app for people with serious mental illness, Learn to Quit, results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population, NCI QuitGuide. The trial will also demonstrate whether it is possible to (a) feasibly recruit and retain individuals with serious mental illness in an mHealth clinical trial, and (b) successfully gather smoking cessation outcomes. Ninety individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Learn to Quit app. In the comparator condition, participants will use the NCI QuitGuide app. Participants in both conditions will receive Nicotine Replacement Therapy (standard dosing of nicotine patch + 1-week course of 4mg nicotine lozenges) and technical coaching. Study duration will be 4 months, with four follow-up appointments at 1-month, 2-month, 3-month, and 4-months.

Official Title
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Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

Conditions
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Nicotine Addiction, Serious Mental Illness

Intervention / Treatment
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* Device: Learn to Quit App
* Drug: Nicotine patch
* Drug: Nicotine lozenge
* Behavioral: Technical Coaching
* Device: NCI QuitGuide App


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Learn to Quit<br>A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. | Device: Learn to Quit App<br>* 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.<br>Drug: Nicotine patch<br>* 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.<br>Drug: Nicotine lozenge<br>* 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.<br>Behavioral: Technical Coaching<br>* 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.<br>|
| Active Comparator: NCI QuitGuide<br>A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. | Drug: Nicotine patch<br>* 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.<br>Drug: Nicotine lozenge<br>* 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.<br>Behavioral: Technical Coaching<br>* 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.<br>Device: NCI QuitGuide App<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of App Use | Frequency of app openings in each group | Daily throughout study duration, 4 months | 
| Duration of App Use | Mean duration of app use in each group over the course of study participation (4 months) | Daily throughout study duration, 4 months | 
| Feasibility as Measured by Study Accrual Relative to Recruitment Goal | Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization. | Approximately 15 months | 
| Feasibility as Measured by Study Attrition | Number and percentage of subjects who complete 4-month follow up assessment | 4-months | 
| Recruitment Yield Effort | Percent of subjects responding to ads and clinician referrals | Approximately 15 months | 
| Feasibility of Measurement Strategy | Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks. | Approximately 19 months | 
| Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | 1-month follow-up | 
| Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | 2-month follow-up | 
| Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | 3-month follow-up | 
| Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | 4-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 1 month follow-up | 
| Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 2 month follow-up | 
| Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 3 month follow-up | 
| Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 4 month follow-up | 
| Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent | 1 month follow up | 
| Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent | 2 month follow up | 
| Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 3 month follow up | 
| Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 4 month follow up | 
| 30-day Point Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | 1 month follow up | 
| 30-day Point Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | 2 month follow up | 
| 30-day Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | 3 month follow up | 
| 30-day Point Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | 4 month follow up | 
| 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | 1 month follow up | 
| 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | 2 month follow up | 
| 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | 3 month follow up | 
| 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | 4 month follow up | 
| 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | 1 month follow up | 
| 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | 2 month follow up | 
| 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | 3 month follow up | 
| 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | 4 month follow up | 
| Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | 1 month follow up | 
| Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | 2 month follow up | 
| Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | 3 month follow up | 
| Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | 4 month follow up | 
| Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | The Fagerstrom Test of Nicotine Dependence ranges from 0 to 10 with the lower score indicating no dependence and the highest score indicating very dependent | Baseline to 1, 2, 3 and 4 month follow up | 
| Change in Average Number of Cigarettes Smoked Per Day | Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point. | Baseline to 1, 2, 3 and 4 month follow up | 
| Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | 1 month follow up | 
| Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | 2 month follow up | 
| Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | 3 month follow up | 
| Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | 4 month follow up | 
| Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | 1 month follow up | 
| Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | 2 month follow up | 
| Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | 3 month follow up | 
| Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | 4 month follow up | 
| Affect Ratings - Learn to Quit | Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings. | Daily throughout study duration, 4 months | 
| Affect Ratings - QuitGuide | Percent of reported positive, negative, and mixed affect. Negative affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: frustrated, stressed, nervous, anxious, angry, sad. Positive affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: happy, relaxed, excited. Mixed affect was coded as '1' when there were instances where participants reported both positive and negative affect at different times of the day. | Daily throughout study, 4 months | 
| Smoking Cravings | Average daily smoking cravings as self-reported through each smartphone app. Cravings range from a score of 1 to 10 with higher scores indicating higher cravings to smoke. | Daily throughout study duration, 4 months | 
| Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | 1 month follow up | 
| Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | 2 month follow up | 
| Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | 3 month follow up | 
| Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | 4 month follow up | 
| General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | 1 month follow up | 
| General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | 2 month follow up | 
| General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | 3 month follow up | 
| General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | 4 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, mHealth, Serious Mental Illness, Acceptance and Commitment Therapy, US DHHS Clinical Practice Guidelines