Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in smoking urge as assessed by a single 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
This research will address the following specific aims:
Aim 1: To test CBT and Mindfulness/ACT intervention message efficacy for reducing momentary smoking urges (N=80). 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.
Aim 2: To test if exposure to urge reduction messages results in changes in smoking behavior over time compared to an EMA only control group (N=80). It is important to investigate if repeated messages in the micro-randomized trial impact smoking behavior over time, in contrast to just repeated assessment without messages. Thus, this study includes a conventionally randomized clinical-trial component. Parallel to the micro-randomized trial group, a control group completes EMA surveys only without intervention messages. This allows the investigators to test if messages reduce smoking behavior. The primary outcome is number of cigarettes per day at end of treatment, 3-, and 6-months follow-up. Secondary analyses explore biochemically verified 7-day point prevalence abstinence, switching to e-cigarettes, and other tobacco outcomes. Post-hoc dose-response analyses investigate the long-term efficacy of CBT or Mindfulness/ACT messages on smoking behavior.
Aim 3: Explore moderation effects of substance co-use (cannabis, alcohol, other drugs) and exposure to specific location (home, work, bars) on urge reduction message efficacy. A crucial research question to inform future mobile interventions is how well intervention messages work in different situational contexts and when people are co-using other substances. Among intervention group participants, the investigators will explore how urge reduction message efficacy may be moderated by substance co-use and exposure to specific settings.
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
- 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 in their lives and currently smoke at least 3 cigarettes per day on 5 or more days of the week;
- •are planning to quit smoking within the next 30 days.
排除标准
- 未提供
研究组 & 干预措施
Micro-randomized trial group
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)
EMA-only control group
A total of N=80 participants will be randomized into an EMA-only control group, parallel to the micro-randomized trial intervention group. This group will conduct 14-day EMA only training phase just like the micro-randomized trial group, but will not be switched over to the intervention phase after these initial 14 days. Instead, participants will continue the EMA-only data collection procedure for an additional 30-days (analogous to the 30-day intervention phase of the micro-randomized trial). During these 30 days, the EMA-only control group will continue to receive 3 randomly prompted EMA surveys per day and an additional 3 EMA surveys triggered by smoking reports.
结局指标
主要结局
Change in smoking urge as assessed by a single item
时间窗: 15 minutes after message delivery
The primary outcome will be change in participants' rating of smoking urge in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Urge will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).
Change in cigarettes smoked per day in past week as assessed by a single item
时间窗: Baseline, 45-day, 3-month, and 6-month 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-day, 3-month, and 6-month follow-up.
次要结局
- Change in psychological flexibility as assessed by the CompACT-15(Baseline, 45-day, 3-month, and 6-month follow-up)
- Change in stress as assessed by a single item(15 minutes after message delivery)
- Change in negative affect as assessed by a single item(15 minutes after message delivery)
- Other tobacco product use since intervention message delivery as assessed by a single item(15 minutes after message delivery)
- Activity completion as assessed by a single item(15 minutes after message delivery)
- Self-reported 7-day point prevalence abstinence as assessed by a single item(6-month follow-up)
- Tobacco quit attempt as a assessed by a single item(Baseline, 45-day, 3-month, and 6-month follow-up)
- Smoking since intervention message delivery as assessed by a single item(15 minutes after message deliery)
- Message helpfulness as assessed by a single item(15 minutes after message delivery)
- Saliva-cotinine confirmed 7-day point prevalence abstinence(6-month follow-up)
- Change in frequency and intensity of smoking urges as assessed by two items of the Mood and Physical Symptoms Scale (MPSS)(Baseline, 45-day, 3-month, and 6-month follow-up)
- Change in smoking-specific experiential avoidance as assessed by the Avoidance and Inflexibility Scale (AIS)(Baseline, 45-day, 3-month, and 6-month follow-up)
- Change in cigarettes smoked as assessed by a single item(Baseline, 45-day, 3-month, and 6-month follow-up)
- Tobacco product switching as assessed by 5 questions(Baseline, 45-day, 3-month, and 6-month follow-up)
- Self-reported 7-day point prevalence abstinence as assessed by a single item(45-day follow-up)
- Self-reported 7-day point prevalence abstinence as assessed by a single item(3-month follow-up)
- Saliva-cotinine confirmed 7-day point prevalence abstinence(45-day follow-up)
- Saliva-cotinine confirmed 7-day point prevalence abstinence(3-month follow-up)