A SMART Pilot of Adaptive Treatment Strategies to Improve Engagement With a Web-Based Intervention for Socially Anxious Smokers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Utilization of Phase 1 text messages
研究概览
简要总结
This phase I trial will use a pilot sequential multiple assignment randomized trial (SMART) to examine protocol feasibility and acceptability of new components of a web-based intervention for socially anxious smokers. This study will be used to help build an adaptive treatment strategy to improve engagement with and effectiveness of the web-based intervention. Adaptive treatment strategies provide individualized sequences of intervention components to accommodate the changing needs of individuals based on their characteristics, treatment response, or engagement.
详细描述
This study proposes to use a pilot SMART to help build an adaptive treatment strategy to improve engagement with and effectiveness of a web-based intervention for socially anxious smokers. At the outset of the study (Phase 1), participants will receive access to a new web-based smoking intervention (MyWebQuit) and will randomized to receive one of two text message services: 1) 1-way text messages, or 2) interactive, 2-way text messages. Those who disengage with the website in the first 5 weeks will be re-randomized to one of three re-engagement strategies: 1) re-engagement emails, 2) re-engagement interactive text messages, or 3) no re-engagement strategy. Outcomes include protocol feasibility, treatment acceptability, treatment utilization, and smoking cessation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
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
- •resides in the US and anticipates remaining in the US for the duration of the study
- •smokes at least 5 cigarettes per day for at least 12 months prior to screening
- •desire to quit smoking within 30 days
- •has at least weekly internet access
- •current use of a personal email account
- •current use of text messaging
- •willing to receive text messages as part of this study
- •screen positive for social anxiety (LSAS-SR ≥ 60)
- •interested in participating in the study for themselves (versus [vs] someone else)
- •not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
- •no prior participation in one of the investigator's prior smoking cessation studies,
- •comfortable reading, writing, and speaking English
- •agree to the conditions of compensation
- •not currently incarcerated in a prison
- •willing to use the MyWebQuit program, complete study assessments, and sign an online consent form
- •no other member of their same household participating in the study
排除标准
- 未提供
结局指标
主要结局
Utilization of Phase 1 text messages
时间窗: 3 months
Proportion of participants who unsubscribe from the Phase 1 text messages
Recruitment
时间窗: Recruitment
Number of individuals screened, eligible, consented; reasons for ineligibility
Data retention
时间窗: 3 months
Percentage of participants who complete outcome assessment at 3-months
Acceptability of intervention and Phase 2 engagement components
时间窗: 3 months
Treatment satisfaction ratings of the Phase 2 treatment conditions
Utilization of interactive messages
时间窗: 3 months
Proportion of interactive text message prompts participants respond to
Acceptability of intervention and Phase 1 engagement components
时间窗: 3 months
Treatment satisfaction ratings of the Phase 1 treatment conditions.
Website Utilization
时间窗: 3 months
Total website logins
次要结局
- Biochemically confirmed smoking abstinence(3 months)
- Self-reported 7-day point prevalence abstinence(3 months)
- Self-reported 30-day point prevalence abstinence(3 months)