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

An mHealth Mood Management Tool to Improve Population-Level Cessation

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Behavioral: Smoking Cessation Intervention (Actify app); Behavioral: Smoking Cessation Intervention (Current Standard Care app); Other: Health Promotion and Education

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.

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Survey Administration; Ancillary studies; Behavioral: Smoking Cessation Intervention (Actify app); Use Actify app; Other Names: Smoking and Tobacco Use Cessation Interventions; Other: Health Promotion and Education; Receive motivational messages and smoking cessation information via text notifications
Active Comparator: 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.	Other: Survey Administration; Ancillary studies; Behavioral: Smoking Cessation Intervention (Current Standard Care app); Use (USCPG) Current Standard Care app; Other Names: Smoking and Tobacco Use Cessation Interventions; Other: Health Promotion and Education; Receive motivational messages and smoking cessation information via text notifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Application (App) Utilization	Number of app openings during the 8-week treatment period.	At 8 weeks post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jaimee Heffner, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RG1121054; NCI-2020-05454 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 10540 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); R34DA050967 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No