Long-Term Effectiveness of a Clinician-Assisted Digital Cognitive Behavioral Therapy Intervention for Smoking Cessation: Secondary Outcomes From a Randomized Controlled Trial.

INTRODUCTION: This study evaluated the secondary effectiveness outcomes for Quit Genius, a digital clinician-assisted cognitive behavioral therapy (CBT) intervention for smoking cessation. METHODS: Adult smokers (N = 556) were randomly assigned to Quit Genius (n = 277), a digital, clinician-assisted CBT intervention or very brief advice (VBA) to stop smoking, an evidence-based, 30-s intervention designed to facilitate quit attempts, coupled with referral to a cessation service (n = 279). Participants were offered combination nicotine replacement therapy (patches and gum) tailored to individual nicotine dependence. Analyses (n = 530), by intention-to-treat, compared Quit Genius and VBA at 4, 26, and 52 weeks post-quit date (QD). The primary outcome was self-reported 7-day point prevalence abstinence (PPA) at 4 weeks post-QD. Consecutive 7-day point-prevalence abstinence, defined as abstinent at two or more consecutive timepoints, was examined at weeks 26 and 52 to indicate long-term effectiveness. Abstinence was verified using a random sample of participants with carbon monoxide breath testing of <5 parts per million (n = 280). RESULTS: Self-reported consecutive 7-day PPA at weeks 26 and 52 for Quit Genius was 27.2% and 22.6%, respectively, compared with VBA which was 16.6% and 13.2% (RR = 1.70, 95% CI, 1.22-2.37; p = .003, 26 weeks; RR = 1.71, 95% CI, 1.17-2.50; P = .005, 52 weeks). Biochemically verified abstinence was significantly different at 26- (p = .03) but not 52 weeks (p = .16). Quit Genius participants were more likely to remain abstinent than those who received VBA (RR = 1.71, 95% CI 1.17-2.50; p = .005). CONCLUSIONS: This study provides secondary evidence for the long-term effectiveness of Quit Genius in comparison with VBA. Future trials of digital interventions without clinician support and comparisons with active treatment are needed. IMPLICATIONS: The long-term effectiveness of clinician-assisted digital smoking cessation interventions has not been well studied. This study established the long-term effectiveness of an extended CBT-based intervention; results may inform implementation of scalable approaches to smoking cessation in the health system.

Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial.

BACKGROUND: Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. OBJECTIVE: Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. METHODS: A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date. RESULTS: A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed. CONCLUSIONS: The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476.

Effective Behavioral Changes through a Digital mHealth App: Exploring the Impact of Hedonic Well-Being, Psychological Empowerment and Inspiration.

BACKGROUND: New mobile health (mHealth) software apps are emerging and are providing the foundation to radically transform the practice and reach of medical research and care. For this study we collaborated with Quit Genius, a cognitive behavioral therapy (CBT) based mHealth app that helps users quit smoking, to explore the effective design of a digital mHealth app; one that delivers important benefits to its users and helps them change their behaviors for a healthier lifestyle. OBJECTIVE: The specific aims of this study were to (1) explore the key role of CBT program progress, (2) examine the gamification design app elements that deliver significant benefits (ie, empowerment, well-being, inspiration) to users, (3) explore the effectiveness of these app elements to help users quit smoking or reduce the number of cigarettes smoked, and (4) identify and describe any potential drivers and hindrances arising from the app design elements. METHODS: We developed an online survey and sent an email invitation to 4144 individuals, who had previously or were at the time using the Quit Genius mHealth app, to encourage participation in the study. We matched the online survey data with objective app usage data of the study participants. RESULTS: A dataset of 190 completed responses was used. At the time of the survey, respondents had completed an average of 60% of the CBT program in the Quit Genius mHealth app. Of the respondents, 36.3% (69/190) noted to have quit smoking successfully after using the Quit Genius app. As for those who remained smokers after using the app (N=121), the number of cigarettes smoked per day was significantly reduced by 59.6%. The ability of the app to enhance users' hedonic well-being and psychologically empower them in their daily lives was identified as being key in helping users quit smoking. Specifically, the results show that users whose well-being was enhanced through the app were 1.72 times more likely to quit smoking successfully. Moreover, a one-unit increase on a 7-point Likert scale in the app's ability to empower smokers in their daily lives led to a reduction of cigarettes smoked per day of 53%. The app's inspiration to users, however, was negatively associated with quitting success and the reduction in cigarette smoked per day. CONCLUSIONS: The findings offer important insights for the effective design of digital mHealth apps. Specifically, we find that perceived psychological empowerment and enhanced hedonic well-being from the mobile solution may be a more impactful way to support the effectiveness of mobile cognitive behavioral therapy for smoking cessation than eliciting strong inspiration.

Evaluation of Two Mobile Health Apps in the Context of Smoking Cessation: Qualitative Study of Cognitive Behavioral Therapy (CBT) Versus Non-CBT-Based Digital Solutions.

BACKGROUND: Mobile health (mHealth) apps can offer users numerous benefits, representing a feasible and acceptable means of administering health interventions such as cognitive behavioral therapy (CBT). CBT is commonly used in the treatment of mental health conditions, where it has a strong evidence base, suggesting that it represents an effective method to elicit health behavior change. More importantly, CBT has proved to be effective in smoking cessation, in the context of smoking-related costs to the National Health Service (NHS) having been estimated to be as high as £2.6bn in 2015. Although the evidence base for computerized CBT in mental health is strong, there is limited literature on its use in smoking cessation. This, combined with the cost-effectiveness of mHealth interventions, advocates a need for research into the effectiveness of CBT-based smoking cessation apps. OBJECTIVE: The objective of this study was, first, to explore participants' perceptions of 2 mHealth apps, a CBT-based app, Quit Genius, and a non-CBT-based app, NHS Smokefree, over a variety of themes. Second, the study aimed to investigate the perceptions and health behavior of users of each app with respect to smoking cessation. METHODS: A qualitative short-term longitudinal study was conducted, using a sample of 29 smokers allocated to one of the 2 apps, Quit Genius or Smokefree. Each user underwent 2 one-to-one semistructured interviews, 1 week apart. Thematic analysis was carried out, and important themes were identified. Descriptive statistics regarding participants' perceptions and health behavior in relation to smoking cessation are also provided. RESULTS: The thematic analysis resulted in five higher themes and several subthemes. Participants were generally more positive about Quit Genius's features, as well as about its design and information engagement and quality. Quit Genius users reported increased motivation to quit smoking, as well as greater willingness to continue using their allocated app after 1 week. Moreover, these participants demonstrated preliminary changes in their smoking behavior, although this was in the context of our limited sample, not yet allowing for the finding to be generalizable. CONCLUSIONS: Our findings underscore the use of CBT in the context of mHealth apps as a feasible and potentially effective smoking cessation tool. mHealth apps must be well developed, preferably with an underlying behavioral change mechanism, to promote positive health behavior change. Digital CBT has the potential to become a powerful tool in overcoming current health care challenges. The present results should be replicated in a wider sample using the apps for a longer period so as to allow for generalizability. Further research is also needed to focus on the effect of greater personalization on behavioral change and on understanding the psychological barriers to the adoption of new mHealth solutions.

Game On? Smoking Cessation Through the Gamification of mHealth: A Longitudinal Qualitative Study.

BACKGROUND: Finding ways to increase and sustain engagement with mHealth interventions has become a challenge during application development. While gamification shows promise and has proven effective in many fields, critical questions remain concerning how to use gamification to modify health behavior. OBJECTIVE: The objective of this study is to investigate how the gamification of mHealth interventions leads to a change in health behavior, specifically with respect to smoking cessation. METHODS: We conducted a qualitative longitudinal study using a sample of 16 smokers divided into 2 cohorts (one used a gamified intervention and the other used a nongamified intervention). Each participant underwent 4 semistructured interviews over a period of 5 weeks. Semistructured interviews were also conducted with 4 experts in gamification, mHealth, and smoking cessation. Interviews were transcribed verbatim and thematic analysis undertaken. RESULTS: Results indicated perceived behavioral control and intrinsic motivation acted as positive drivers to game engagement and consequently positive health behavior. Importantly, external social influences exerted a negative effect. We identified 3 critical factors, whose presence was necessary for game engagement: purpose (explicit purpose known by the user), user alignment (congruency of game and user objectives), and functional utility (a well-designed game). We summarize these findings in a framework to guide the future development of gamified mHealth interventions. CONCLUSIONS: Gamification holds the potential for a low-cost, highly effective mHealth solution that may replace or supplement the behavioral support component found in current smoking cessation programs. The framework reported here has been built on evidence specific to smoking cessation, however it can be adapted to health interventions in other disease categories. Future research is required to evaluate the generalizability and effectiveness of the framework, directly against current behavioral support therapy interventions in smoking cessation and beyond.