This phase I trial investigates a new smartphone application (called Actify) for improving population-level smoking cessation and mood management. Actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone application that is based on current clinical practice guidelines. Participants will be randomly assigned to receive one of two smartphone applications and accompanying text notifications to help with quitting smoking and improved mood.
OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. ARM II: Participants use United States (US) Clinical Practice Guidelines (USCPG) app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. After completion of study, participants are followed up at 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
242
Receive motivational messages and smoking cessation information via text notifications
Use Actify app
Use (USCPG) Current Standard Care app
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
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.
Time frame: At 8 weeks post-randomization
Application (App) Utilization
Number of app openings during the 8-week treatment period.
Time frame: At 8 weeks post-randomization
Biochemically-confirmed 30-day PPA From Smoking
Self-reported 30-day smoking abstinence at 8 weeks, confirmed via expired carbon monoxide (CO\<6ppm)
Time frame: At 8 weeks post-randomization
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?"
Time frame: At 6 months post-randomization
Biochemically-confirmed 30-day PPA From Smoking
Self-reported 30-day smoking abstinence at 6 months, confirmed via expired carbon monoxide (CO\<6 ppm)
Time frame: At 6 months post-randomization
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?"
Time frame: At 8 weeks post-randomization
Biochemically Confirmed 7-day PPA From Smoking
Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO \< 6ppm)
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Ancillary studies
Time frame: At 8 weeks post-randomization
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?"
Time frame: At 6 months post-randomization
Biochemically Confirmed 7-day PPA From Smoking
Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO \< 6ppm)
Time frame: At 6 months post-randomization
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?"
Time frame: At 8 weeks post-randomization
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)
Time frame: At 8 weeks post-randomization
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?"
Time frame: At 6 months post-randomization
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)
Time frame: At 6 months post-randomization
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.
Time frame: Baseline to 8 weeks
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?"
Time frame: At 8 weeks post-randomization
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.
Time frame: Baseline to 8 weeks post-randomization