Full length articleRandomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy
Introduction
On the fiftieth anniversary of the landmark 1964 US Surgeon General's Report on Smoking and Health (US Department of Health E., and Welfare, 1964), the 2014 Surgeon General's report concludes that, while all forms of tobacco use are unsafe, cigarette smoking: (1) accounts for 480,000 deaths; (2) remains the number one preventable cause of premature death; (3) causes diabetes and multiple cancers including colorectal and liver cancers; and (4) leads to $289 billion in healthcare and lost productivity costs annually in the US alone (CDC, 2014). The decline in the smoking prevalence has slowed in recent years, with 42 million Americans still smoking. States’ funding for population-level smoking cessation programs (e.g., quitlines) remains far below CDC-recommended levels. Consequently, there is a tremendous need for interventions with strong potential population-level impact at the lowest possible cost (CDC, 2014).
That potential can be found in the newest technological innovation in quit smoking interventions: smartphone-based smoking cessation software applications (“apps”; Abroms et al., 2011, Abroms et al., 2013, Buller et al., 2013). Smartphones apps have all of the beneficial features of websites and text messaging interventions, but without their limitations (Abroms et al., 2013, Buller et al., 2013, Chen et al., 2012). Specifically, smartphone apps can have these important features: (1) available at arm's reach, (2) visually-engaging design, (3) video and audio capabilities, (4) unrestricted text capabilities, (5) access without cellular or internet connection, (6) immediate access to intervention content, (7) optimized to smartphone screen size, (8) content sharable via social media, and (9) tracking progress anywhere and anytime. Indeed, apps are an important technological advance over web sites and text messaging programs because of their high potential to boost user engagement—a consistently strong predictor of smoking cessation (Civljak et al., 2010, Shahab and McEwen, 2009, Webb, 2009, Whittaker et al., 2012).
Smoking interventions’ population-level impact is driven by the number of smokers they reach and their effectiveness. Smartphone apps for smoking cessation now have enormous reach. In 2013, there were over 400 smoking cessation apps (Abroms et al., 2013). In March 2014, using the xyo.net app search engine, we found a total of 546 English language smoking cessation apps in the Apple Store and Google Play that were downloaded to smartphones an estimated 3.2 million times in the United States and 20 million times worldwide. By contrast, during 2012–2013, there were an estimated 1 million enrollments to US tobacco quitlines (Consortium, 2013, Leischow et al., 2012) and an estimated 140,000 total subscriptions to US text messaging programs (L. Abroms, personal communication, March 4, 2014; E. Augustson, personal communication, March 4, 2014).
The reach of smoking cessation apps is climbing rapidly, greatly aided by the growing ownership of smartphones. The majority (58%) of US adults now own smartphones (Smith, 2013), and ownership is projected to reach at least 90% by 2020 (Dediu, 2013, Statista, 2014). Importantly, minority ownership is strong, with 64% of African Americans and 60% of Hispanics now owning smartphones, as compared to 53% for Caucasians (Smith, 2013). The greatest ownership growth rate is among those with low incomes (Nielsen, 2013, Smith, 2013). The current and projected demographics of smartphone ownership suggest that this treatment modality could address known tobacco-related health disparities associated with race/ethnicity and socioeconomic status (Fagan et al., 2004).
The effectiveness of smartphone apps for smoking cessation is largely unknown. Except for a pilot trial of young adults (Buller et al., 2013), no randomized trials of their effectiveness for general adult cessation have been published. The contrast between smoking cessation apps’ high usage and their lack of effectiveness data is a serious scientific gap that could stifle their population-level impact.
The current standard in smoking cessation interventions is the US Clinical Practice Guidelines (USCPG). The USCPG have the following essential content: tracking smoking status, offering quit planning, advice on pharmacotherapy, tools to enhance motivation, and social support for quitting (Fiore et al., 2008). Of the apps now available, a small minority follow the USCPG (Abroms et al., 2011, Abroms et al., 2013). However, just following the USCPG is likely insufficient. For example, multiple recent meta-analyses of websites and of text messaging interventions that follow USCPG report that their average intent-to-treat 30-day point prevalence quit rates at 12 months post-randomization are remarkably similar, ranging from 7% to 10% (Civljak et al., 2010, Hutton et al., 2011, Shahab and McEwen, 2009, Whittaker et al., 2012). Consequently, an app that goes a key step beyond the USCPG through innovative theory-based intervention content has promise to produce higher quit rates.
To start a smartphone research paradigm focusing on innovative intervention content, the current study will compare an app that follows USCPG with one that adds novel content based on a behavior change model called acceptance and commitment therapy (ACT; Hayes et al., 2006). ACT focuses on increasing willingness to experience physical cravings, emotions, and thoughts while making values-guided committed behavior changes. In ACT, acceptance means making room for intense physical cravings (e.g., urges to smoke), emotions (e.g., sadness that triggers smoking), and thoughts (e.g., thoughts that trigger smoking) while allowing them to come and go. Commitment in ACT means articulating what is deeply meaningful to individuals – i.e., their values – to motivate and guide specific plans of action (e.g., stopping smoking). Numerous studies have supported the effectiveness of ACT for a wide variety of problems including depression and drug addiction (Hayes et al., 2006, Hayes et al., 2013).
This study addressed the dual needs for (1) innovative theory-based intervention content and (2) controlled trials to evaluate the efficacy of apps for smoking cessation. Accordingly, we developed the first smartphone app-delivered ACT intervention for smoking cessation, called “SmartQuit.” We then conducted a nationally-recruited randomized, controlled pilot trial comparing SmartQuit with the National Cancer Institute's QuitGuide app. The aims were to determine (1) trial design feasibility, (2) participant receptivity and satisfaction, (3) preliminary cessation outcomes overall and for two key subgroups (those reporting: (a) heavy smoking; (b) low acceptance of cravings), and (4) potential impact on acceptance of cravings to smoke—ACT's theory-based process of change.
Section snippets
Participants
Eligibility criteria: (1) age 18 or older; (2) smokes at least five cigarettes daily for at least past 12 months, as consistent with cessation trials (Civljak et al., 2010); (3) wants to quit in the next 30 days; (4) interested in learning skills to quit smoking; (5) willing to be randomly assigned to either smartphone application; (6) resides in US; (7) knows how to download a smartphone application from Apple's App Store; (8) willing and able to read English; (9) not using other smoking
Baseline balance and follow-up retention
Demographic characteristics, smoking behavior, and ACT theory-based measures were balanced between treatment groups at baseline, with the exception of race (Table 1). More participants identified themselves as Caucasian in the QuitGuide arm than in the ACT arm (94% vs. 85%, p = 0.06). The overall retention rate at two-month follow-up was 84% and did not differ between study groups (p = 0.56). Some baseline characteristics were predictive of two-month retention, including higher educational
Discussion
This study addressed the dual needs for innovative theory-based intervention content and controlled trials to evaluate the efficacy of apps for smoking cessation. Accordingly, the aims were to determine (1) trial design feasibility, (2) participant receptivity and satisfaction, (3) preliminary cessation outcomes overall and for two key subgroups (heavy smokers and low acceptors of cravings), and (4) potential impact on theory-based acceptance of cravings to smoke. In general, the results
Conclusion
ACT is feasible to deliver by smartphone app, acceptable to the majority of users, and shows promising quit rates compared to an app that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed to further stimulate research on smartphone apps for smoking cessation.
Role of funding source
This study was funded by the Hartwell Innovation Fund of the Fred Hutchinson Cancer Research Center. Dr. Bricker's writing of this manuscript was partly supported by grants from the National Cancer Institute (no. R01CA166646; no. R01CA151251). Dr. Heffner's work on the project was supported by a grant from the National Institute on Drug Abuse (no. K23DA026517). Dr. Vilardaga's contribution to this manuscript was supported by a training grant from the National Institute of Mental Health (
Contributors
Dr. Bricker conceived the study, led the entire conduct of the trial, contributed to the analysis planning, led the results interpretation, and was the primary manuscript writer. Ms. Mull led the analysis planning, conducted the analyses, and contributed to the manuscript writing. Dr. Vilardaga participated in the results interpretation and contributed to the manuscript writing. Dr. Kientz participated in the results interpretation and manuscript writing. Ms. Mercer participated in the analysis
Conflict of interest statement
In 2011, Dr. Heffner served as a consultant for Pfizer. All of the authors declare that they have no other potential conflicts of interest. 2Morrow Inc. is developing SmartQuit under license from FHCRC, and all license proceeds will be used in support of the Fred Hutchinson Cancer Research Center and its research mission.
Acknowledgements
We are thankful to our entire study staff—especially, Eric Meier, Carolyn Ehret, Jessica Harris, and Madelon Bolling. We are grateful for the programming expertise provided by 2Morrow Inc. We gratefully appreciate the participants for volunteering for this study.
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