Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Smoking Urge as Assessed by Survey Item
研究概览
简要总结
Clinical practice guidelines for smoking cessation emphasize cognitive behavioral therapy (CBT) to help patients develop coping strategies for urges. Mindfulness or Acceptance and commitment Therapy (ACT) offer a different approach, which teaches smokers psychological flexibility through accepting negative experiences. While there is evidence for the efficacy of both CBT and Mindfulness/ACT smoking cessation interventions, it is unclear if these approaches are efficacious when implemented in real-time and with young adults. The overall goal of this proposal is to evaluate the efficacy of CBT and Mindfulness/ACT messages for young adults targeted at specific high-risk situations for smoking.
详细描述
To conduct a pilot trial to test CBT and Mindfulness/ACT intervention message efficacy for reducing momentary smoking urges (N=10). To inform just-in-time interventions, it is crucial to test if CBT and Mindfulness/ACT based messages can reduce momentary smoking urges. The investigators will conduct a micro-randomized trial (repeated within-subject randomizations of messages) to accomplish this. In line with the investigators' existing protocol, participants first collect Ecological Momentary Assessment (EMA) data for 14 days, allowing the investigators to determine high-risk situations for smoking. In the following intervention phase, participants receive tailored messages triggered by geofencing of participants' high-risk locations for a total of 30 days. Tailoring is based on established predictors of smoking relapse (stress and presence of other smokers). The micro-randomized trial tests the efficacy of CBT versus Mindfulness/ACT versus control messages for reducing smoking urge 15 minutes post message delivery. Secondary outcomes include smoking or other tobacco use (including e-cigarettes), affect, and stress. After 45 days, follow up interviews with participants will be conducted to collect information on their study experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •live in the U.S.
- •read English;
- •are between 18 and 30 years of age;
- •own an iPhone or Android smartphone;
- •have smoked ≥100 cigarettes and currently smoke at least 1 cigarette per day on 3 or more days of the week;
- •are planning to quit smoking within the next 30 days.
排除标准
- •live internationally
- •don't read English
- •younger than 18, older than 30
- •don't own a iPhone or Android smartphone
- •have smoked less than 100 cigarettes
- •not planning to quit smoking in the next 30 days
研究组 & 干预措施
Single arm pilot
The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization).
干预措施: Smartphone-based intervention messages (Behavioral)
结局指标
主要结局
Smoking Urge as Assessed by Survey Item
时间窗: Baseline, 15 minutes after message delivery
The primary outcome is change in participants' rating of smoking urge from pre- to post-message surveys. Urge is assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high) in pre and post surveys. Pre-message surveys are completed immediately before message delivery and post-message surveys are prompted 15 minutes after intervention message delivery. . Data presented here are Mean and Standard Deviation of smoking urge before (pre-message EMA) and after (follow-up EMA) a message was delivered for the different message conditions (Control, Cognitive behavioral therapy (CBT), Mindfulness or Acceptance and commitment Therapy (ACT)). Messages were randomized within subjects.
Change in Number of Cigarettes Smoked Per Day in Past Week as Assessed by a Single Item
时间窗: Baseline, 45-day follow-up
The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-days.
次要结局
未报告次要终点