| 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. | Overall number of participants analyzed include those who opened the app at least once AND answered at least one acceptability question in the 8 week follow-up survey. | Posted | | Mean | Standard Deviation | units on a scale | | At 8 weeks post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0004.1± 1.0
- OG0013.7± 1.1
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from "not at all" to "very much". We used a linear regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (<20 Cigs/ >=20 Cigs), and Baseline Depression Severity (PHQ-8<5 / PHQ-8>=5) to test for differences between arms." | Regression, Linear | Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (<20 Cigs/ >=20 Cigs), Baseline Depression Severity (PHQ-8<5 / PHQ-8>=5) | 0.0088 | | Slope | 0.42 | | | 2-Sided | 95 | 0.10 | 0.74 | | | | | Other |
|
| Primary | Application (App) Utilization | Number of app openings during the 8-week treatment period. | We used negative binomial regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (<20 Cigs/ >=20 Cigs), and Baseline Depression Severity (PHQ-8<5 / PHQ-8>=5) to compare number of app openings by treatment arm | Posted | | Mean | Standard Deviation | app openings | | At 8 weeks post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| Secondary | Biochemically-confirmed 30-day PPA From Smoking | Self-reported 30-day smoking abstinence at 8 weeks, confirmed via expired carbon monoxide (CO<6ppm) | | Posted | | Number | | participants | | At 8 weeks post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| 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?" | | Posted | | Count of Participants | | Participants | | At 6 months post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| 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) | | Posted | | Count of Participants | | Participants | | At 6 months post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| 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?" | | Posted | | Count of Participants | | Participants | | At 8 weeks post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| Secondary | Biochemically Confirmed 7-day PPA From Smoking | Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm) | | Posted | | Count of Participants | | Participants | | At 8 weeks post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| 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?" | | Posted | | Count of Participants | | Participants | | At 6 months post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| Secondary | Biochemically Confirmed 7-day PPA From Smoking | Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm) | | Posted | | Count of Participants | | Participants | | At 6 months post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| 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?" | | Posted | | Count of Participants | | Participants | | At 8 weeks post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
|
| 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) | | Posted | | Count of Participants | | Participants | | At 8 weeks post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| 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?" | | Posted | | Count of Participants | | Participants | | At 6 months post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
|
| 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) | | Posted | | Count of Participants | | Participants | | At 6 months post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| 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. | Follow-up score minus baseline score. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
|
| 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?" | | Posted | | Count of Participants | | Participants | | At 8 weeks post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
| |
| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to 8 weeks post-randomization | | | | ID | Title | Description |
|---|
| OG000 | Arm I (Actify, Text Notifications) | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies | | OG001 | Arm II (Current Standard Care, Text Notifications) | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies |
|