Mindful Breaths: Mindfulness for Young Adult Vaping

Официальное название

Mindful Breaths: A Pilot Randomized Trial on Mindfulness for Young Adult Vaping

Обзор

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary efficacy of mindfulness-based interventions (MBI) as a vaping cessation intervention in young adults aged 18-29 who vape nicotine at least 25 days per month and are interested in cutting down or quitting. The main questions it aims to answer are: * Can mindfulness practice reduce nicotine cravings in young adults? * Is mindfulness practice an acceptable and feasible intervention for vaping cessation in this population? Researchers will compare participants in the mindfulness intervention group to a control group that watches a video with calming music and images to see if mindfulness practice has a greater effect on reducing nicotine cravings. Participants will: * Complete a baseline survey and craving cue reactivity assessment. * Engage in a 10-minute guided mindfulness meditation (intervention group) or view calming music and images (control group). * Rate their cravings and the acceptability, appropriateness, and feasibility of the intervention after the session.

Вмешательства

• Поведенческое Guided mindfulness meditation
  Watching a video of a guided mindfulness meditation include paying attention to the breath, promoting natural breathing without force; body scan, directing awareness from the head down to the toes, allowing tension to release in each area. The intervention emphasizes observing sensations without judgment, fostering a state of relaxed awareness.
• Поведенческое Scenery video
  Watching a ten-minute video of calming music and images

Первичные конечные точки

• Satisfaction [Срок оценки: Within ten minutes after the completion of a single 10-minute guided meditation session]
• Intervention appeal [Срок оценки: Within ten minutes after the completion of a single 10-minute guided meditation session]
• Intervention appropriateness [Срок оценки: Within ten minutes after the completion of a single 10-minute guided meditation session]
• Intervention feasibility [Срок оценки: Within ten minutes after the completion of a single 10-minute guided meditation session]
• Perceived effectiveness [Срок оценки: Within ten minutes after the completion of a single 10-minute guided meditation session]
• Likelihood to continue mindfulness practice [Срок оценки: Within ten minutes after the completion of a single 10-minute guided meditation session]

Вторичные конечные точки (1)

• Craving [Срок оценки: Within 20 minutes before and after a ten minute guided mindfulness meditation practice.]

Критерии участия

Критерии включения

• Young adults aged 18-29 years old
• Residing in the United States
• Able to read and speak English
• Vape nicotine at least 25 days/month,
• Interested in cutting down or quitting vaping in the next 30 days (rated at least a 5 on a 10-point scale).

Критерии исключения

• Using any nicotine-containing products other than e-cigarettes
• A current or past Diagnostic and Statistical Manual of Mental Disorders (DSM-5) psychiatric diagnosis of severe mental illness
• A current DSM diagnosis of substance use disorders other than tobacco use disorder
• Involved in regular mindful practice
• Undergoing current smoking/vaping cessation treatment (counseling and/or medication)
• Taking any medications that may potentially affect nicotine craving, consumption, or mood within the past 30 days.

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

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06626529 · 2024-1480

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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