Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey |
Overall treatment satisfaction is reported on a Likert-type scale, with response choices ranging from "not at all=1" to "very much=5". Higher values are associated with higher level of satisfaction. |
At 8 weeks post-randomization |
|
| Primary |
Application (App) Utilization |
Number of app openings during the 8-week treatment period. |
At 8 weeks post-randomization |
|
| Secondary |
Biochemically-confirmed 30-day PPA From Smoking |
Self-reported 30-day smoking abstinence at 8 weeks, confirmed via expired carbon monoxide (CO<6ppm) |
At 8 weeks post-randomization |
|
| Secondary |
Self-reported 30-day PPA From Smoking |
Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?" |
At 6 months post-randomization |
|
| Secondary |
Biochemically-confirmed 30-day PPA From Smoking |
Self-reported 30-day smoking abstinence at 6 months, confirmed via expired carbon monoxide (CO<6 ppm) |
At 6 months post-randomization |
|
| Secondary |
Self-reported 7-day PPA From Smoking |
Self-reported 7-day abstinence on the survey question of "When was the last time you smoked, or even tried, a cigarette?" |
At 8 weeks post-randomization |
|
| Secondary |
Biochemically Confirmed 7-day PPA From Smoking |
Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm) |
At 8 weeks post-randomization |
|
| Secondary |
Self-reported 7-day PPA From Smoking |
Self-reported 7-day abstinence on the survey question of "When was the last time you smoked, or even tried, a cigarette?" |
At 6 months post-randomization |
|
| Secondary |
Biochemically Confirmed 7-day PPA From Smoking |
Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm) |
At 6 months post-randomization |
|
| Secondary |
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes |
Self-reported 30-day abstinence on the survey questions of "Have you smoked at all, even a puff, in the last 30 days?" & "In the last 30 days, how often did you use any kind of e-cigarette or vaping product?" & "In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?" |
At 8 weeks post-randomization |
|
| Secondary |
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes |
Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO < 6ppm) |
At 8 weeks post-randomization |
|
| Secondary |
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes |
Self-reported 30-day abstinence on survey questions of "Have you smoked at all, even a puff, in the last 30 days?" & "In the last 30 days, how often did you use any kind of e-cigarette or vaping product?" & "In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?" |
At 6 months post-randomization |
|
| Secondary |
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes |
Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO < 6ppm) |
At 6 months post-randomization |
|
| Secondary |
Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8) |
The Patient Health Questionnaire-8 (PHQ-8) is an assessment of depressive symptoms used to detect symptom changes over time as a result of treatment. The PHQ-8 asks the number of days in the past 2 weeks the respondent had experienced a particular depressive symptom. Possible answers are "not at all" or "several days" or "more than half the days" or "nearly every day," with points (0 to 3) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. |
Baseline to 8 weeks |
|
| Secondary |
Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking |
Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?" |
At 8 weeks post-randomization |
|
| Secondary |
Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS) |
The Behavioral Activation for Depression Scale (BADS) is a 25-item scale used to track changes in behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. BADS items are rated on a 7-point scale ranging from 0 (not at all) to 6 (completely). The behavioral activation subscale contains 7 items, with a scoring range of 0 to 42. Change scores reflect the value of the BADS behavioral activation subscale score at 8-week follow-up minus the baseline score. Positive change values indicate an increase in behavioral activation (i.e, an improvement), whereas negative scores indicate a decrease in behavioral activation. |
Baseline to 8 weeks post-randomization |
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