Clinical trial NCT03069482: Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
Official title: Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Addiction
Serious Mental Illness
Keywords: Smoking
mHealth
Serious Mental Illness
Acceptance and Commitment Therapy
US DHHS Clinical Practice Guidelines
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-03-03
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Days of App Use
timeFrame: Daily throughout study duration, 4 months
measure: Duration of App Use
timeFrame: Daily throughout study duration, 4 months
measure: Feasibility as Measured by Study Accrual Relative to Recruitment Goal
timeFrame: Approximately 15 months
measure: Feasibility as Measured by Study Attrition
timeFrame: 4-months
measure: Recruitment Yield Effort
timeFrame: Approximately 15 months
measure: Feasibility of Measurement Strategy
timeFrame: Approximately 19 months
measure: Usability of App Design as Measured by the System Usability Scale (SUS)
timeFrame: 1-month follow-up
measure: Usability of App Design as Measured by the System Usability Scale (SUS)
timeFrame: 2-month follow-up
measure: Usability of App Design as Measured by the System Usability Scale (SUS)
timeFrame: 3-month follow-up
measure: Usability of App Design as Measured by the System Usability Scale (SUS)
timeFrame: 4-month follow-up
Secondary outcomes:
measure: Biochemically Confirmed 7-day Point Prevalence Abstinence
timeFrame: 1 month follow-up
measure: Biochemically Confirmed 7-day Point Prevalence Abstinence
timeFrame: 2 month follow-up
measure: Biochemically Confirmed 7-day Point Prevalence Abstinence
timeFrame: 3 month follow-up
measure: Biochemically Confirmed 7-day Point Prevalence Abstinence
timeFrame: 4 month follow-up
measure: Biochemically Confirmed Prolonged Abstinence Rates
timeFrame: 1 month follow up
measure: Biochemically Confirmed Prolonged Abstinence Rates
timeFrame: 2 month follow up
measure: Biochemically Confirmed Prolonged Abstinence Rates
timeFrame: 3 month follow up
measure: Biochemically Confirmed Prolonged Abstinence Rates
timeFrame: 4 month follow up
measure: 30-day Point Prevalence Abstinence Rates
timeFrame: 1 month follow up
measure: 30-day Point Prevalence Abstinence Rates
timeFrame: 2 month follow up
measure: 30-day Prevalence Abstinence Rates
timeFrame: 3 month follow up
measure: 30-day Point Prevalence Abstinence Rates
timeFrame: 4 month follow up
measure: 7-day Point Prevalence Abstinence
timeFrame: 1 month follow up
measure: 7-day Point Prevalence Abstinence
timeFrame: 2 month follow up
measure: 7-day Point Prevalence Abstinence
timeFrame: 3 month follow up
measure: 7-day Point Prevalence Abstinence
timeFrame: 4 month follow up
measure: 24-hour Point Prevalence Abstinence
timeFrame: 1 month follow up
measure: 24-hour Point Prevalence Abstinence
timeFrame: 2 month follow up
measure: 24-hour Point Prevalence Abstinence
timeFrame: 3 month follow up
measure: 24-hour Point Prevalence Abstinence
timeFrame: 4 month follow up
measure: Average Number of Quit Attempts Per Arm
timeFrame: 1 month follow up
measure: Average Number of Quit Attempts Per Arm
timeFrame: 2 month follow up
measure: Average Number of Quit Attempts Per Arm
timeFrame: 3 month follow up
measure: Average Number of Quit Attempts Per Arm
timeFrame: 4 month follow up
measure: Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence
timeFrame: Baseline to 1, 2, 3 and 4 month follow up
measure: Change in Average Number of Cigarettes Smoked Per Day
timeFrame: Baseline to 1, 2, 3 and 4 month follow up
measure: Nicotine Replacement Patch Utilization
timeFrame: 1 month follow up
measure: Nicotine Replacement Patch Utilization
timeFrame: 2 month follow up
measure: Nicotine Replacement Patch Utilization
timeFrame: 3 month follow up
measure: Nicotine Replacement Patch Utilization
timeFrame: 4 month follow up
measure: Nicotine Replacement Lozenge Utilization
timeFrame: 1 month follow up
measure: Nicotine Replacement Lozenge Utilization
timeFrame: 2 month follow up
measure: Nicotine Replacement Lozenge Utilization
timeFrame: 3 month follow up
measure: Nicotine Replacement Lozenge Utilization
timeFrame: 4 month follow up
measure: Affect Ratings - Learn to Quit
timeFrame: Daily throughout study duration, 4 months
measure: Affect Ratings - QuitGuide
timeFrame: Daily throughout study, 4 months
measure: Smoking Cravings
timeFrame: Daily throughout study duration, 4 months
measure: Psychotic Symptoms
timeFrame: 1 month follow up
measure: Psychotic Symptoms
timeFrame: 2 month follow up
measure: Psychotic Symptoms
timeFrame: 3 month follow up
measure: Psychotic Symptoms
timeFrame: 4 month follow up
measure: General Psychiatric Symptoms
timeFrame: 1 month follow up
measure: General Psychiatric Symptoms
timeFrame: 2 month follow up
measure: General Psychiatric Symptoms
timeFrame: 3 month follow up
measure: General Psychiatric Symptoms
timeFrame: 4 month follow up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Roger Vilardaga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Browne J, Halverson TF, Vilardaga R. Engagement with a digital therapeutic for smoking cessation designed for persons with psychiatric illness fully mediates smoking outcomes in a pilot randomized controlled trial. Transl Behav Med. 2021 Sep 15;11(9):1717-1725. doi: 10.1093/tbm/ibab100.