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

Duke University

Status and phase: Completed; Phase 1

Conditions: Nicotine Addiction; Serious Mental Illness

Treatments: Device: NCI QuitGuide App; Behavioral: Technical Coaching; Drug: Nicotine patch; Drug: Nicotine lozenge; Device: Learn to Quit App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03069482

Pro00075165

4R00DA037276-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Learn to Quit

Experimental group

Description:

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.

Treatment:

Behavioral: Technical Coaching

Drug: Nicotine patch

Drug: Nicotine lozenge

Device: Learn to Quit App

NCI QuitGuide

Active Comparator group

Description:

A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.

Treatment:

Device: NCI QuitGuide App

Behavioral: Technical Coaching

Drug: Nicotine patch

Drug: Nicotine lozenge