Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
- Conditions
- Nicotine AddictionSerious Mental Illness
- Interventions
- Device: Learn to Quit AppDrug: Nicotine patchDrug: Nicotine lozengeBehavioral: Technical CoachingDevice: NCI QuitGuide App
- Registration Number
- NCT03069482
- Lead Sponsor
- Duke University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Learn to Quit Nicotine patch 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. Learn to Quit Learn to Quit App 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. Learn to Quit Nicotine lozenge 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. Learn to Quit Technical Coaching 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. NCI QuitGuide Technical Coaching A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. NCI QuitGuide Nicotine patch A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. NCI QuitGuide Nicotine lozenge A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. NCI QuitGuide NCI QuitGuide App A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
- Primary Outcome Measures
Name Time Method Days of App Use Daily throughout study duration, 4 months Frequency of app openings in each group
Duration of App Use Daily throughout study duration, 4 months Mean duration of app use in each group over the course of study participation (4 months)
Feasibility as Measured by Study Attrition 4-months Number and percentage of subjects who complete 4-month follow up assessment
Recruitment Yield Effort Approximately 15 months Percent of subjects responding to ads and clinician referrals
Feasibility as Measured by Study Accrual Relative to Recruitment Goal Approximately 15 months Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization.
Feasibility of Measurement Strategy Approximately 19 months Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.
Usability of App Design as Measured by the System Usability Scale (SUS) 4-month follow-up 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.
- Secondary Outcome Measures
Name Time Method Biochemically Confirmed 7-day Point Prevalence Abstinence 4 month follow-up 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.
30-day Prevalence Abstinence Rates 3 month follow up Participants who self-reported not smoking for 30 days prior to the specified timepoint.
30-day Point Prevalence Abstinence Rates 4 month follow up Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Biochemically Confirmed Prolonged Abstinence Rates 4 month follow up 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.
Nicotine Replacement Lozenge Utilization 4 month follow up Days of lozenge use over the last 30 days.
Affect Ratings - Learn to Quit Daily throughout study duration, 4 months Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings.
Smoking Cravings Daily throughout study duration, 4 months 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.
Psychotic Symptoms 4 month follow up 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.
General Psychiatric Symptoms 4 month follow up 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.
7-day Point Prevalence Abstinence 4 month follow up Participants who self-reported not smoking for 7 days prior to the specified timepoint.
24-hour Point Prevalence Abstinence 4 month follow up Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Average Number of Quit Attempts Per Arm 4 month follow up Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence Baseline to 1, 2, 3 and 4 month follow up 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"
Change in Average Number of Cigarettes Smoked Per Day Baseline to 1, 2, 3 and 4 month follow up Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point.
Nicotine Replacement Patch Utilization 4 month follow up Days of patch use over the last 30 days.
Affect Ratings - QuitGuide Daily throughout study, 4 months 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.
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States