Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07493252

A Behavioral Application for Improving Smoking Cessation Among Smokers

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location contact

Jaimee Heffner, PhD

CONTACT

[email protected]

206-667-7314

Jaimee Heffner, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Education

Other

Receive motivational messages and smoking cessation information via text messages

Survey Administration

Other

Ancillary studies

Primary outcomes

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

    Time frame: At 6 months post-randomization

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

Secondary outcomes

  1. Biochemically-confirmed 30-day PPA from cigarette smoking

    Time frame: At 6 months post-randomization

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

  2. Self-reported 7-day PPA from cigarette smoking

    Time frame: At 8 weeks post-randomization

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

  3. Self-reported 7-day PPA from cigarette smoking

    Time frame: At 6 months post-randomization

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

  4. 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

    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)

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

    Time frame: At 6 months post-randomization

    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)

  6. Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications

    Time frame: At 8 weeks post-randomization

    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)

  7. Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications

    Time frame: At 6 months post-randomization

    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)

  8. Biochemically confirmed 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications

    Time frame: At 6 months post-randomization

    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

  9. Biochemically confirmed 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications

    Time frame: At 6 months post-randomization

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jaimee Heffner, PhD

CONTACT

[email protected]

206-667-7314

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 25, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.