A Behavioral Application for Improving Smoking Cessation Among Smokers

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Health Promotion and Education; Behavioral: Smartphone app-based Intervention (Actify! A app); Behavioral: Smartphone app-based Intervention (Actify! B app)

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.

• Study Type: Interventional
• Enrollment (Estimated): 1812
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaimee Heffner, PhD; Phone Number: 206-667-7314; Email: jheffner@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Jaimee Heffner, PhD; Phone Number: 206-667-7314; Email: jheffner@fredhutch.org
      • Principal Investigator: Jaimee Heffner, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (Actify! A app); Participants use the Actify! 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.	Other: Survey Administration; Ancillary studies; Other: Health Promotion and Education; Receive motivational messages and smoking cessation information via text messages; Behavioral: Smartphone app-based Intervention (Actify! A app); Use Actify! A app
Active Comparator: Arm II (Actify! B app); Participants use an 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.	Other: Survey Administration; Ancillary studies; Other: Health Promotion and Education; Receive motivational messages and smoking cessation information via text messages; Behavioral: Smartphone app-based Intervention (Actify! B app); Use Actify! B app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking	Percentage of participants self-reporting no smoking over the previous 30 days	At 6 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically-confirmed 30-day PPA from cigarette smoking	Percentage of participants reporting no smoking over the previous 30 days, confirmed via carbon monoxide testing	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	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	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)	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)	At 6 months post-randomization
Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications	Percentage of participants reporting no smoking over the prior 30 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum)	At 8 weeks post-randomization
Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications	Percentage of participants reporting no smoking over the prior 30 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum)	At 6 months post-randomization
Biochemically confirmed 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), confirmed via carbon monoxide and cotinine testing	At 6 months post-randomization
Biochemically confirmed 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications	Percentage of participants reporting no smoking over the prior 30 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum), confirmed via carbon monoxide and cotinine testing	At 6 months post-randomization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Health Education; Educational Status; Health Promotion
• Other Study ID Numbers: RG1126036; NCI-2025-09044 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U01DA062241 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The study researchers for this study plan to preserve and share the following:

• Survey Data: De-identified individual and aggregate survey data (including raw and recoded data) necessary to replicate main outcomes will be shared. The de-identification process will remove direct and indirect respondent identifiers prior to sharing.
• App utilization data: Individual level, de-identified aggregate data necessary to replicate main outcomes (e.g., summary number of log-ins, pages viewed, or other app events) will be shared. The de-identification process will remove direct and indirect respondent identifiers.

Documentation made publicly available to the research community will include PDFs of various study materials.

At this time, the study researchers plan to share scientific data and meta-data in NCI's Cancer Data Service (CDS): https://dataservice.datacommons.cancer.gov/#/home.

• IPD Sharing Time Frame: Final data submission and release of data used in publications will occur at the time of publication. Other shared data will be made available at or before the end of the project period. The study researchers will follow the data retention plan of the final selected repository, but at a minimum, researchers intend to ensure that data is available for a period of not less than 5 years after the end of this trial.
• IPD Sharing Access Criteria: All data sharing will be done in compliance with NIH data sharing policies, applicable laws and regulations, and in accordance with guidance from journal publishers. CDS allows open and controlled access to data to ensure access is provided to qualified researchers, data access is tracked, and users understand how to cite and credit use of the data. Data will only be shared for non-profit, non-commercial and non-proprietary purposes to qualified researchers or as allowed by CDS. Based on the nature of the data, which is not sensitive, the study researchers anticipate making it publicly available (as opposed to controlled access) but will follow final recommendations from the IRB as to whether access should be controlled.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

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