Novel Use of mHealth Data to Identify States of Vulnerability and Receptivity to JITAIs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Biochemically Verified Smoking Abstinence
研究概览
简要总结
This study aims to investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers.
详细描述
Investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts. Investigate whether, what type, and under what conditions (e.g., current state of vulnerability and/or receptivity) a prompt to engage the individual in self-regulatory activities via mobile app increases engagement, hence reduces vulnerability.
The proposed research will help build a comprehensive conceptual, technical, and empirical foundation necessary to develop effective Just-in-Time-Adaptive-Interventions (JITAIs) based on dynamic models of vulnerability and receptivity. In the micro-randomized trial (MRT), Ecological momentary assessments (EMAs) assessed proximal engagement with self-regulatory strategies, substance use, and other contextual factors after each micro-randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •18 years of age or older
- •Current smoker with an average of at least 3 cigarettes/day
- •Motivated to quit within the next 30 days
- •Valid home address in Utah, Nevada, and Arizona
- •Functioning telephone number and access to reliable wifi
- •Can speak, read, and write in English
- •At least marginal health literacy (as determined by 45 or greater on REALM literacy test)
排除标准
- •Contraindication for nicotine patch or gum
- •Current use of tobacco cessation medications or other aids (i.e. buproprion)
- •Pregnancy or lactation (as self-reported)
研究组 & 干预措施
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available) (Behavioral)
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available) (Behavioral)
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are not available) (Behavioral)
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: Messages recommending low effort strategies (when participants did not complete the 2-question survey) (Behavioral)
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: More effortful activity: Meditate (Behavioral)
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: More effortful activity: Imagine (Behavioral)
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available) (Behavioral)
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: More effortful activity: Moodsurf (Behavioral)
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: More effortful activity: Joy (Behavioral)
Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
干预措施: More effortful activity: Notice (Behavioral)
结局指标
主要结局
Biochemically Verified Smoking Abstinence
时间窗: Post-quit date - 6-month follow-up
Smoking abstinence will be completed via self-reported status from participants which are biochemically verified by either expired carbon monoxide via a breathalyzer or a cotinine sample as needed if a participant is unable to attend a visit in-person.
Proportion of Randomized Decision Points in Which Participant Reported Proximal Engagement by Randomized Assignment
时间窗: 1 hour following micro-randomization
Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy. Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below. The three EMA items used to operationalize PE were: 1. "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No); 2. "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No); 3. "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No). Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant.
Proportion of Randomized Decision Points in Which the Participant Reported Proximal Engagement by Randomized Assignment.
时间窗: 1 hour following micro-randomization
Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy. Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below. The three EMA items used to operationalize PE were: 1. "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No); 2. "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No); 3. "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No). Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant.
次要结局
- Proximal Cigarette Use(approximately 1 hour following the decision point)
- Proximal Nicotine-Containing Non-Cessation Product (NCNCP) Use(approximately 1 hour following the decision point)
- Proximal Tobacco Product Use (PTPU) Use(approximately 1 hour following the decision point)