mHealth Mood Management Tool (Actify) to Improve Population-Level Smoking Cessation

Phase 1

Completed

Conditions: Cigarette Smoking-Related Carcinoma

Interventions: Other: Health Promotion and Education
Behavioral: Smoking Cessation Intervention (Actify app)
Behavioral: Smoking Cessation Intervention (Current Standard Care app)
Other: Survey Administration

Registration Number: NCT04525222

Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 242

Inclusion Criteria

Current smoker, averaging at least 5 cigarettes/day for the last 30 days
Interested in quitting smoking in the next 30 days
Experience downloading and using one or more apps on their smartphone
Either screens negative (Patient Health Questionnaire - 9 Item [PHQ-9] score 0-4) for depression or screens positive for mild to moderate current depressive symptoms (PHQ-9 score 5-19)
Willing and able to complete all study activities
Comfortable reading and writing in English
Have a mobile data plan and/or access to WiFi to support the use of the Actify app
Reside in the US
Have a smartphone either an iPhone (running iOS version 11 or higher) or an Android phone (running version 5.0 or higher)

Exclusion Criteria

Currently receiving behavioral treatment for depression (e.g., psychotherapy)
Current use of a depression app
Severe depression (PHQ-9 >= 20)
Receiving other treatment for smoking cessation
Previous use of the QuitGuide app
Current or recent (within the past year) enrollment in a Fred Hutch smoking cessation study
Employees/family of investigator or study center
Member of the same household as another participant
Woman who is pregnant or breastfeeding, or planning to become pregnant
Currently incarcerated
Is ineligible per fraud prevention protocol

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (Actify, text notifications)	Health Promotion and Education	Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
Arm I (Actify, text notifications)	Smoking Cessation Intervention (Actify app)	Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
Arm II (Current Standard Care, text notifications)	Health Promotion and Education	Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
Arm I (Actify, text notifications)	Survey Administration	Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
Arm II (Current Standard Care, text notifications)	Smoking Cessation Intervention (Current Standard Care app)	Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
Arm II (Current Standard Care, text notifications)	Survey Administration	Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.

Primary Outcome Measures

Name	Time	Method
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey	At 8 weeks post-randomization	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.
Application (App) Utilization	At 8 weeks post-randomization	Number of app openings during the 8-week treatment period.

Secondary Outcome Measures

Name	Time	Method
Biochemically-confirmed 30-day PPA From Smoking	At 6 months post-randomization	Self-reported 30-day smoking abstinence at 6 months, confirmed via expired carbon monoxide (CO\<6 ppm)
Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)	Baseline to 8 weeks post-randomization	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.
Biochemically Confirmed 7-day PPA From Smoking	At 6 months post-randomization	Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO \< 6ppm)
Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)	Baseline to 8 weeks	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.
Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking	At 8 weeks post-randomization	Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?"
Self-reported 30-day PPA From Smoking	At 6 months post-randomization	Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?"
Self-reported 7-day PPA From Smoking	At 6 months post-randomization	Self-reported 7-day abstinence on the survey question of "When was the last time you smoked, or even tried, a cigarette?"
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes	At 6 months post-randomization	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?"
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes	At 6 months post-randomization	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)