Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Smartphone-based intervention messages.
- Кому может быть актуально
- Состояния в реестре: Tobacco Cigarette Smoking. Базовые параметры: 18 лет — 30 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Smartphone-based intervention messages
Intervention messages in the proposed trial will address specific high-risk situations for smoking and smoking urges. Messages will focus on two key situational triggers for message matching: 1. Stress (high/low) and 2. Presence of other smokers (yes/no). For each situation, characterized by a combination of these characteristics, several messages were developed. To improve user engagement with the intervention, all messages contain visual content in form of pictures.
Первичные конечные точки
- Change in smoking urge as assessed by a single item [Срок оценки: 15 minutes after message delivery]
- Change in cigarettes smoked per day in past week as assessed by a single item [Срок оценки: Baseline, 45-day, 3-month, and 6-month follow-up]
Вторичные конечные точки (12)
- Smoking since intervention message delivery as assessed by a single item [Срок оценки: 15 minutes after message deliery]
- Other tobacco product use since intervention message delivery as assessed by a single item [Срок оценки: 15 minutes after message delivery]
- Change in stress as assessed by a single item [Срок оценки: 15 minutes after message delivery]
- Change in negative affect as assessed by a single item [Срок оценки: 15 minutes after message delivery]
- Message helpfulness as assessed by a single item [Срок оценки: 15 minutes after message delivery]
- Activity completion as assessed by a single item [Срок оценки: 15 minutes after message delivery]
- Self-reported 7-day point prevalence abstinence as assessed by a single item [Срок оценки: 45-day follow-up]
- Self-reported 7-day point prevalence abstinence as assessed by a single item [Срок оценки: 3-month follow-up]
- Self-reported 7-day point prevalence abstinence as assessed by a single item [Срок оценки: 6-month follow-up]
- Saliva-cotinine confirmed 7-day point prevalence abstinence [Срок оценки: 45-day follow-up]
- Saliva-cotinine confirmed 7-day point prevalence abstinence [Срок оценки: 3-month follow-up]
- Saliva-cotinine confirmed 7-day point prevalence abstinence [Срок оценки: 6-month follow-up]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- None
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Johns Hopkins Bloomberg School of Public Health — Baltimore
Публикации
- Thrul J, Devkota J, Waring JJC, Desjardins MR, Hamoud J, Han J, Naughton F, Zipunnikov V, Mendelson T, Latkin C, Epstein D, Moran M. App-Based Smoking Urge Reduction Intervention for Young Adults: Protocol Combining a Microrandomized Trial and Conventional Between-Subject Randomized Trial. JMIR Res Protoc. 2025 Sep 23;14:e74388. doi: 10.2196/74388. PMID 40987452
Идентификаторы
NCT: NCT05836103 · IRB00013413