Development and Evaluation of a Brief Behavioral Activation Mobile Application for Nicotine Vaping Cessation Among Adolescent Primary Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Number/Duration of Quit Attempts
研究概览
简要总结
The purpose of this study is to evaluate a mobile application (app) called "Goal2QuitVaping" to help adolescents quit vaping nicotine. Goal2QuitVaping was developed by our research team to assist with quitting vaping. Participants will be randomly assigned to either download the mobile app, "Goal2QuitVaping", or not. If provided with Goal2QuitVaping, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 4 weeks.
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
- None
入排标准
- 年龄范围
- 16 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •vaped nicotine on ≥20 days out of the last 30
- •elevated depressive symptoms, defined as a score of ≥10 on Patient Health Questionnaire-8 (PHQ-8) during preliminary screening and the Adolescent Patient Health Questionnaire-9 (PHQ-9A) at final eligibility
- •currently own an iOS or Android smartphone
- •report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item)
- •have a valid e-mail address that is checked regularly or regular access to text messages (for follow-up assessments)
- •ability to read the consent form
- •has been seen (in person or remotely) by a primary care physician within the last year
排除标准
- •smoked cigarettes or used other tobacco products on ≥9 days out of the last 30
- •severe visual impairment
- •currently receiving treatment for vaping or tobacco use
- •current suicidal ideation, defined as a response ≥1 on item nine of the PHQ-9A or ≥2 on item 9 of the BDI-II
- •household member currently enrolled in the study
- •inability to read the consent form
结局指标
主要结局
Number/Duration of Quit Attempts
时间窗: Across all 4 weeks
Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks
Mean Score of Depressive Symptoms
时间窗: Up to 4 weeks
Patients will self report depressive symptoms weekly for 4 weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression. This outcome will measure change from baseline at week 4.
Average Vapes Per Day at Week 4
时间窗: Week 4
Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.
E-cigarette Dependence
时间窗: Up to 4 weeks
Assessed at baseline via the 10-item Penn State Electronic Cigarette Dependence Index (ECDI). Change from baseline at week 4. The scores range from 0-20 with 0-3= not dependent, 4-8 low dependence, 9-12 medium dependence, 13+ = high dependence.
7-day Point Prevalence Abstinence
时间窗: At any point during the study
Assessed during the Timeline Followback. At any point during the study across all 4 weeks.
次要结局
未报告次要终点
研究者
Jennifer Dahne
Assistant Professor
Medical University of South Carolina