Cigarette Smoking-Related Carcinoma
Conditions
Brief summary
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
BEHAVIORALSmartphone app-based Intervention (Actify! A app)
Use Actify! A app
BEHAVIORALSmartphone app-based Intervention (Actify! B app)
Use Actify! B app
OTHERHealth Promotion and Education
Receive motivational messages and smoking cessation information via text messages
OTHERSurvey Administration
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking | At 6 months post-randomization | Percentage of participants self-reporting no smoking over the previous 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically-confirmed 30-day PPA from cigarette smoking | At 6 months post-randomization | Percentage of participants reporting no smoking over the previous 30 days, confirmed via carbon monoxide testing |
| Self-reported 7-day PPA from cigarette smoking | At 8 weeks post-randomization | Percentage of participants reporting no cigarette smoking over the prior 7 days |
| Self-reported 7-day PPA from use of all nicotine/tobacco products except Food and Drug Administration (FDA)-approved medications | 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) |
| Self-reported 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications | 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) |
| Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications | 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) |
| Biochemically confirmed 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications | 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 |
| Biochemically confirmed 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications | 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 |
Countries
United States
Contacts
CONTACTJaimee Heffner, PhD
PRINCIPAL_INVESTIGATORJaimee Heffner, PhD
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed