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



Status:Completed
Conditions:Smoking Cessation, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:May 15, 2017
End Date:January 17, 2019

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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.

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
GuitGuide 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.

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)
We found this trial at
1
site
Durham, North Carolina 27710
(919) 684-8111
Phone: 919-681-3493
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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mi
from
Durham, NC
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