Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Use Disorder and Serious Mental Illness
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Introduction: High rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population. Methods: In a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16. Results: Compared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = 0.10). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions. Conclusions: This pilot trial provides strong evidence of Learn to Quit’s usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI. Implications: This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.
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In a pilot RCT of 62 adults with serious mental illness, at 4 months, 30-day abstinence rates were 12% for Learn to Quit versus 3% for QuitGuide (P=0.23), and the difference was not statistically significant likely due to lack of power.
“In this study of 62 adults with serious mental illness, at 4 months, the 30-day abstinence rates were 12% for Learn to Quit versus 3% for QuitGuide (P=0.23). The quit rates in the Learn to Quit arm were modest and not statistically significantly different from the QuitGuide likely due to lack of power.”
From Can an Acceptance and Commitment Therapy-Based Smartphone App Help Individuals with Mental Health Disorders Quit Smoking? (2024) · cites this paper as [47]
Presently, there is limited evidence for the efficacy of smartphone apps delivering behavioral smoking cessation interventions for individuals with mental health disorders; most studies have been limited to small pilot RCTs and single-arm studies.
“Presently, there is limited evidence for the efficacy of smartphone apps delivering behavioral smoking cessation interventions for individuals with mental health disorders. Most studies have been limited to small pilot randomized controlled trials (RCTs) and single-arm studies [43, 44, 45, 46, 47].”
From Can an Acceptance and Commitment Therapy-Based Smartphone App Help Individuals with Mental Health Disorders Quit Smoking? (2024) · cites this paper as [47]
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Acceptance and Commitment Therapy (ACT) for Smoking Cessation: A Scoping Review
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An Open-label Pilot Study of NicoBloc as a Novel Smoking Cessation Intervention
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Digital Therapeutics for Nicotine Dependence
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Smoking Cessation Apps and Technology Acceptance Factors: Focusing on the Sense2Quit Application
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- Authors
- Vilardaga, R., Rizo, J., Palenski, P. E., Mannelli, P., Oliver, J. A., & Mcclernon, F. J.
- Affiliations
- Duke University (US)
- Corresponding author
- Vilardaga, Roger
- Venue
- Nicotine & Tobacco Research
- Publisher
- Oxford University Press (OUP)
- Published
- 2019-10-31
- Volume
- 22
- Issue
- 9
- Pages
- 1533-1542
- ISSN
- 1462-2203 (ISSN-L)
- 1469-994X
- PMC
- PMC7443597
- OpenAlex
- W2983517446
- Cited by
- 55
- References
- 56
- Citations by year
- 2026: 9 · 2025: 10 · 2024: 7 · 2023: 10 · 2022: 8 · 2021: 9 · 2020: 1 · 2019: 1
- FWCI
- 3.26
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Nicotine & Tobacco Research (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Drug Abuse (R00 DA037276)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Keywords
- smoking cessation, severe mental illness, tobacco use disorder, mobile health apps, digital interventions, nicotine replacement therapy, abstinence, app usability, feasibility, psychiatric symptoms
- MeSH terms
- Smokers, Adult, Behavior Therapy, Mental Disorders, Female, Humans, Male, Middle Aged, North Carolina, Pilot Projects, Tobacco Use Disorder, Smoking Cessation, Telemedicine, Tobacco Use Cessation Devices, Mobile Applications
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