A Behavioral Application for Improving Smoking Cessation Among Smokers

Official title

Actify! An mHealth Mood Management Tool to Improve Population-Level Smoking Cessation

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.

Detailed description

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.

Interventions

• Behavioral Smartphone app-based Intervention (Actify! A app)
  Use Actify! A app
• Behavioral Smartphone app-based Intervention (Actify! B app)
  Use Actify! B app
• Other Health Promotion and Education
  Receive motivational messages and smoking cessation information via text messages
• Other Survey Administration
  Ancillary studies

Primary outcome measures

• Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking [Time frame: At 6 months post-randomization]

Secondary outcome measures (9)

• Biochemically-confirmed 30-day PPA from cigarette smoking [Time frame: At 6 months post-randomization]
• Self-reported 7-day PPA from cigarette smoking [Time frame: At 8 weeks post-randomization]
• Self-reported 7-day PPA from cigarette smoking [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 [Time frame: At 8 weeks post-randomization]
• Self-reported 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications [Time frame: At 6 months post-randomization]
• Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications [Time frame: At 8 weeks post-randomization]
• Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications [Time frame: At 6 months post-randomization]
• Biochemically confirmed 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications [Time frame: At 6 months post-randomization]
• Biochemically confirmed 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications [Time frame: At 6 months post-randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT07493252 · RG1126036 · NCI-2025-09044 · U01DA062241

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗