Key Outcomes of Interest
depression, schizophrenia, anxiety, bipolar disorder
DISORDER, SECONDARY
As a pilot study, we examined a range of primary and secondary outcomes to inform the feasibility, acceptability, and potential impact of the EC version relative to the SC version of GEMS. A key outcome was whether people would install the app. Among those who did, primary outcomes of interest, each assessed at 3-month follow-up, were total number of user sessions, presence of a self-reported quit attempt lasting at least 24 hours, and a self-report of no smoking for the past 7 days (7-day point prevalent abstinence [PPA]).Secondary outcomes used to assess program use and engagement included total duration of app usage calculated as number of days between installation and last use; total number of usage badges earned; number of participants who earned enough usage badges to request free NRT; proportion of those earning NRT who requested it; the proportion of participants who clicked on the Call Now button to access free quitline counseling; and the number of people who used each app feature.Satisfaction was assessed based on users’ overall satisfaction with their assigned program’s content and advice. All ratings used a 5-point Likert scale from “not at all” to “extremely.” In the EC arm, users also rated the helpfulness of each experiment using a 5-point Likert scale from “not helpful” to “very helpful.” Ratings were made in real time following the completion of each experiment.Additional secondary outcomes included motivation and self-efficacy for both smoking fewer cigarettes a day and quitting smoking, each assessed as cognitive intermediaries of behavior change at the 1-month follow-up using 10-point Likert scales ranging from “not at all” to “extremely.” Other secondary indices of behavior change included a self-reported quit attempt lasting at least 24 hours, assessed at 1 month; self-reported 7-day PPA at 1 month; and the proportion of participants who reported a 50% or greater reduction in smoking from baseline to the 3-month follow-up.Baseline assessment measures included participant demographics, use of smartphones and smoking apps, tobacco and e-cigarette use, and self-reported lifetime diagnosis or treatment for depression, anxiety, bipolar disorder, schizophrenia, alcohol use disorder, or drug use (assessed as a single yes or no for any of the listed conditions). Nicotine dependence was assessed with the Fagerström Test of Nicotine Dependence (FTND) [