An mHealth Mood Management Tool to Improve Population-Level Cessation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey
研究概览
简要总结
This phase I trial investigates a new smartphone application (called Actify) for improving population-level smoking cessation and mood management. Actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone application that is based on current clinical practice guidelines. Participants will be randomly assigned to receive one of two smartphone applications and accompanying text notifications to help with quitting smoking and improved mood.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
ARM II: Participants use United States (US) Clinical Practice Guidelines (USCPG) app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
After completion of study, 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
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Any outcome evaluator who has direct contact with participants will be blinded to treatment group assignment
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
- •Current smoker, 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 (Patient Health Questionnaire - 9 Item [PHQ-9] score 0-4) for depression or screens positive for mild to moderate current depressive symptoms (PHQ-9 score 5-19)
- •Willing and able to complete all study activities
- •Comfortable reading and writing in English
- •Have a mobile data plan and/or access to WiFi to support the use of the Actify app
- •Reside in the US
- •Have a smartphone either an iPhone (running iOS version 11 or higher) or an Android phone (running version 5.0 or higher)
排除标准
- •Currently receiving behavioral treatment for depression (e.g., psychotherapy)
- •Current use of a depression app
- •Severe depression (PHQ-9 >= 20)
- •Receiving other treatment for smoking cessation
- •Previous use of the QuitGuide app
- •Current or recent (within the past year) enrollment in a Fred Hutch smoking cessation study
- •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
- •Currently incarcerated
- •Is ineligible per fraud prevention protocol
结局指标
主要结局
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey
时间窗: At 8 weeks post-randomization
Overall treatment satisfaction is reported on a Likert-type scale, with response choices ranging from "not at all=1" to "very much=5". Higher values are associated with higher level of satisfaction.
Application (App) Utilization
时间窗: At 8 weeks post-randomization
Number of app openings during the 8-week treatment period.
次要结局
- Biochemically-confirmed 30-day PPA From Smoking(At 6 months post-randomization)
- Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)(Baseline to 8 weeks post-randomization)
- Biochemically Confirmed 7-day PPA From Smoking(At 6 months post-randomization)
- Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)(Baseline to 8 weeks)
- Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking(At 8 weeks post-randomization)
- Self-reported 30-day PPA From Smoking(At 6 months post-randomization)
- Self-reported 7-day PPA From Smoking(At 6 months post-randomization)
- Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes(At 6 months post-randomization)
- Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes(At 6 months post-randomization)
研究者
Jaimee Heffner
Associate Professor
Fred Hutchinson Cancer Center