A Behavioral Application for Improving Smoking Cessation Among Smokers

N/ANot Yet RecruitingNCT07493252

Fred Hutchinson Cancer Center1,812 enrolled

Overview

This clinical trial compares two smartphone applications, called Actify! (A \& B) for improving smoking cessation outcomes in individuals who smoke. Actify! A is an app grounded in behavioral activation therapy, an evidence-based treatment for depression that can also be used to modify health behaviors such as smoking. The Actify! B app provides evidence-based tobacco cessation strategies based on current clinical guidelines.

OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants use the Actify! A app, which helps users identify personal values and meaningful activities, prompts users to schedule and complete meaningful activities, visualizes progress towards meeting activity and smoking-related goals, and provides tailored messages, resources, daily tips, personalized feedback, inspirational messages, and user stories, for 8 weeks on study. ARM II: Participants use the Actify! B app, which contains quit advice, tools for tracking smokefree days, progress and cravings, guidance on preparing to quit, managing cravings and withdrawal, recovering from slips, and a mood management feature, for 8 weeks on study. After completion of study intervention, participants are followed up at 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,812

Conditions

Cigarette Smoking-Related Carcinoma

Interventions

Smartphone app-based Intervention (Actify! A app)BEHAVIORAL

Use Actify! A app

Smartphone app-based Intervention (Actify! B app)BEHAVIORAL

Use Actify! B app

Health Promotion and EducationOTHER

Receive motivational messages and smoking cessation information via text messages

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 or older * Currently smoke, 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 for depression (Patient Health Questionnaire - 9 item \[PHQ-9\] score 0-4; n = 906) or screens positive for mild to moderately severe current depressive symptoms (PHQ-9 score 5-19; n = 906) * Willing and able to complete all study activities and to receive compensation by mail * Comfortable reading and writing in English * Have a mobile data plan and/or access to WiFi to support the use of the assigned app * Reside in the United States (US) * Willing to provide information for an emergency contact in case of serious concerns about the participant's physical or mental health Exclusion Criteria: * Self-report of currently receiving behavioral treatment for depression (e.g., psychotherapy or counseling, web- or app-based interventions); current use of pharmacotherapy for depression or for other mental health conditions that are not otherwise excluded is allowable (e.g., benzodiazepines, anticonvulsants, opioid agonists, antipsychotics) * Severe depression (PHQ-9 ≥ 20) * Current suicidal ideation reported on the PHQ-9 * History of a suicide attempt * Self-reported lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, antisocial personality disorder, or borderline personality disorder; or self-reported lifetime diagnosis of an alcohol or drug use disorder with use of the substance(s) in the past 30 days * Currently receiving other smoking cessation treatments, including pharmacotherapies (nicotine replacement therapy, bupropion, or varenicline) and behavioral interventions (e.g. quitline counseling, other digital health programs), but excluding electronic (e)-cigarettes/vaping * Previous use of the QuitGuide program * 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 * Having a Google voice number as their primary phone number (due to association with fraudulent study entry attempts in our previous work) * Currently incarcerated * Participated in earlier studies to develop the Actify! app

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking

Percentage of participants self-reporting no smoking over the previous 30 days

Time frame: At 6 months post-randomization

Secondary Outcomes

Biochemically-confirmed 30-day PPA from cigarette smoking

Percentage of participants reporting no smoking over the previous 30 days, confirmed via carbon monoxide testing

Time frame: At 6 months post-randomization

Self-reported 7-day PPA from cigarette smoking

Percentage of participants reporting no cigarette smoking over the prior 7 days

Time frame: At 8 weeks post-randomization

Self-reported 7-day PPA from cigarette smoking

Percentage of participants reporting no cigarette smoking over the prior 7 days

Time frame: At 6 months post-randomization

Self-reported 7-day PPA from use of all nicotine/tobacco products except Food and Drug Administration (FDA)-approved medications

Percentage of participants reporting no smoking over the prior 7 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum)

Time frame: At 8 weeks post-randomization

Self-reported 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications

Percentage of participants reporting no smoking over the prior 7 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum)

Time frame: At 6 months post-randomization

Central Contacts

Jaimee Heffner, PhD

CONTACT

206-667-7314 jheffner@fredhutch.org

Data from ClinicalTrials.gov

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