Actify! An mHealth Mood Management Tool to Improve Population-Level Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,812
- 试验地点
- 1
- 主要终点
- Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Health Promotion and Education (Other)
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.
干预措施: Smartphone app-based Intervention (Actify! B app) (Behavioral)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Health Promotion and Education (Other)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Smartphone app-based Intervention (Actify! A app) (Behavioral)
结局指标
主要结局
Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking
时间窗: At 6 months post-randomization
Percentage of participants self-reporting no smoking over the previous 30 days
次要结局
- Biochemically-confirmed 30-day PPA from cigarette smoking(At 6 months post-randomization)
- Self-reported 7-day PPA from cigarette smoking(At 8 weeks post-randomization)
- Self-reported 7-day PPA from cigarette smoking(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(At 8 weeks post-randomization)
- Self-reported 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications(At 6 months post-randomization)
- Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications(At 8 weeks post-randomization)
- Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications(At 6 months post-randomization)
- Biochemically confirmed 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications(At 6 months post-randomization)
- Biochemically confirmed 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications(At 6 months post-randomization)