Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
Overview
- Phase
- Phase 1
- Intervention
- Learn to Quit App
- Conditions
- Nicotine Addiction
- Sponsor
- Duke University
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Days of App Use
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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)
Arms & Interventions
Learn to Quit
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.
Intervention: Learn to Quit App
Learn to Quit
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.
Intervention: Nicotine patch
Learn to Quit
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.
Intervention: Nicotine lozenge
Learn to Quit
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.
Intervention: Technical Coaching
NCI QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Intervention: Nicotine patch
NCI QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Intervention: Nicotine lozenge
NCI QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Intervention: Technical Coaching
NCI QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Intervention: NCI QuitGuide App
Outcomes
Primary Outcomes
Days of App Use
Time Frame: Daily throughout study duration, 4 months
Frequency of app openings in each group
Duration of App Use
Time Frame: 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
Time Frame: 4-months
Number and percentage of subjects who complete 4-month follow up assessment
Recruitment Yield Effort
Time Frame: Approximately 15 months
Percent of subjects responding to ads and clinician referrals
Feasibility as Measured by Study Accrual Relative to Recruitment Goal
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- Biochemically Confirmed 7-day Point Prevalence Abstinence(4 month follow-up)
- 30-day Prevalence Abstinence Rates(3 month follow up)
- 30-day Point Prevalence Abstinence Rates(4 month follow up)
- Biochemically Confirmed Prolonged Abstinence Rates(4 month follow up)
- Nicotine Replacement Lozenge Utilization(4 month follow up)
- Affect Ratings - Learn to Quit(Daily throughout study duration, 4 months)
- Smoking Cravings(Daily throughout study duration, 4 months)
- Psychotic Symptoms(4 month follow up)
- General Psychiatric Symptoms(4 month follow up)
- 7-day Point Prevalence Abstinence(4 month follow up)
- 24-hour Point Prevalence Abstinence(4 month follow up)
- Average Number of Quit Attempts Per Arm(4 month follow up)
- Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence(Baseline to 1, 2, 3 and 4 month follow up)
- Change in Average Number of Cigarettes Smoked Per Day(Baseline to 1, 2, 3 and 4 month follow up)
- Nicotine Replacement Patch Utilization(4 month follow up)
- Affect Ratings - QuitGuide(Daily throughout study, 4 months)