Principal Findings
substance-related
SECONDARY
The primary objective of this randomized pilot study was to evaluate the feasibility and acceptability of the EC version of the GEMS app and to assess its potential to motivate and support smoking behavior change compared to a similar app that included SC content (SC version) but was not designed specifically for smokers who are ambivalent about quitting smoking. It is encouraging that 95% of the participants who agreed to enroll in the study installed the app. This provides an important initial signal of the intervention’s acceptability. However, because of the size and nature of the study, conclusions about the acceptability and impact of the intervention among participants who installed the app cannot be based on the statistical significance of the primary and secondary outcome comparisons. Instead, it is important to look at the trend and pattern of the point estimates at follow-up. Notably, in almost all cases, the observed outcomes trended in favor of the EC app version. This held true for both self-reported outcomes and those based on objective automated data.As hypothesized, EC participants used the app more often (an average of 19.9 sessions vs 7.3 sessions for SC participants), and a greater proportion reported smoking abstinence at follow-up (14.7% of EC participants vs 6.9% of SC participants). This finding is consistent with previous research showing an association between greater program engagement, or adherence, and higher cessation rates [Additionally, EC participants earned an average of 4 more usage badges. Notably, EC participants had the potential to earn more badges based on the additional content (experiments) in this version, but both groups had equal opportunity to earn the requisite 6 badges needed to request a free trial of NRT, and a higher proportion of EC users met this bar based on their app usage (78.6% EC users vs 62.1% SC users). Additionally, more EC users who earned the NRT, requested to receive it (36.4% EC vs 11.1% SC). Similarly, at the 1-month follow-up, motivation for quitting smoking trended higher in the EC group (8.3 EC vs 7.4 SC on a 10-point scale), even though groups had similar self-efficacy for quitting. More EC users clicked the Call Now button in the app to access free quitline counseling (17.9% of EC vs 3.4% of SC), although it is not known if these individuals actually enrolled in the free quitline program. Finally, a slightly higher proportion of EC users (39.3%) reported making a quit attempt compared to SC users (37.9%) and 28.6% of EC users reported a meaningful reduction in daily smoking at the 3-month follow-up.It is also notable that participants in this trial were lower–socioeconomic status heavy smokers, with high levels of concomitant substance use or lifetime substance-related or mental health diagnoses. These groups have been shown to be less likely to engage in treatment and successfully quit smoking [Taken together, these findings confirm the conclusions drawn from our previous formative work that smokers who are ambivalent about quitting, including those who are more socioeconomically disadvantaged, are interested in using an mHealth app to help them reduce or stop smoking [