Implementation of a Short Mindfulness-based Program for Young Women in Puerto Rico
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: Mindfulness-based stress reduction :MBSR, Usual care.
- Кому может быть актуально
- Состояния в реестре: Stress, Anxiety. Базовые параметры: 18 лет — 29 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Implementation of a Short Mindfulness-based Program for Young Women in Puerto
Обзор
The goal of this study is to evaluate the feasibility and acceptability of a revised 4-week mindfulness program among young women with elevated stress and anxiety in Puerto Rico
Подробное описание
Women in Puerto Rico (PR) experience a high prevalence of cardiometabolic diseases (CMD), with 38% affected by obesity and 42% by hypertension. These rates are higher than those observed in PR men and non-Latinx White women in the continental U.S. Chronic stress is a key risk factor for CMD, and PR women report higher psychological distress than men, despite facing similar social and environmental stressors. Young adult women are particularly vulnerable, as stress during this life stage can shape long-term health outcomes, highlighting the need for targeted interventions.
Mindfulness-Based Stress Reduction (MBSR) is a structured, evidence-based program designed to reduce stress through techniques such as focused attention, open monitoring, and non-judgmental awareness. MBSR has been shown to lower blood pressure, improve heart rate variability (HRV), and reduce psychological distress, including anxiety and depression. The program's emphasis on group sessions aligns well with PR's collectivist culture, making it a potentially effective approach for this population. However, traditional MBSR programs, which span eight weeks with long session durations and extensive home practice, pose feasibility challenges, particularly in PR, where transportation and time constraints are significant barriers.
To overcome these limitations, researchers have adopted a 4-week MBSR program tailored specifically for young PR women, using shorter sessions and telehealth delivery. Preliminary research has demonstrated good participant retention, satisfaction, and improvements in psychological distress among Latinx women, but no randomized controlled trials (RCTs) have been conducted to evaluate MBSR's impact on PR women's cardiometabolic health. The proposed pilot RCT aims to address this gap by testing the feasibility, acceptability, and effectiveness of the adapted 4-week MBSR program, providing a culturally relevant intervention to reduce stress and improve CMD outcomes in this underserved group.
Вмешательства
- Поведенческое Mindfulness-based stress reduction :MBSR
The intervention consists of 4 weekly virtual sessions and daily mindfulness exercises at home (between 1-5min of duration each, according to the participant's availability. Each session lasts 1 hour (except the first one, which is 1.5 hours due to discussion of the program's logistics). The sessions follow a brief check-in, a lecture on the week's topic, and a guided practice exercise. For the audio guides, participants can select a short version of the daily practice exercise or a longer one, - Поведенческое Usual care
Subjects will continue with their usual healthcare routine and lifestyle. Upon completion of all study visits, subjects will be given access to the audio guides and information sheets for voluntary at-home practice exercises
Первичные конечные точки
- Rates of recruitment [Срок оценки: Baseline]
- Rates of retention [Срок оценки: Baseline, 2 months follow up]
- Rates of adherence [Срок оценки: Post intervention (1-month), 2-month follow up]
- Rates of satisfaction [Срок оценки: Post intervention (1 month), 2 months follow up]
Вторичные конечные точки (7)
- Change in Depression symptoms [Срок оценки: Baseline, Post intervention (1 month), 2 months follow up]
- Change in Anxiety (GAD-& score) [Срок оценки: Baseline, Post intervention (1 month), 2 months follow up]
- Change in PTSD symptoms [Срок оценки: Baseline, Post intervention (1 month), 2 months follow up]
- Change in perceived symptoms [Срок оценки: Baseline, Post intervention (1 month), 2 months follow up]
- Change in blood pressure [Срок оценки: Baseline, Post intervention (1 month), 2 months follow up]
- Change in adiposity [Срок оценки: Baseline, Post intervention (1 month), 2 months follow up]
- Heart rate variability (HRV) [Срок оценки: Baseline, Post intervention (1 month), 2 months follow up]
Критерии участия
Критерии включения
- Reporting female sex at birth
- Not identifying as a man, trans man, or trans woman.
- Individuals residing in Puerto Rico
- Spanish speaking
- Currently not pregnant
- Elevated stress (defined as a score >6 in the Perceived Stress Scale (PSS-4)34) or Elevated anxiety (defined as a score of 5 or more on the GAD-7 scale)
- Willing to undergo research activities.
Критерии исключения
- Male sex at birth
- Identifying as a man, trans man, or trans woman.
- Currently pregnant
- Previous participation in an 8-week MBSR program
- Experiencing moderately severe or severe depressive symptoms (PHQ-9>15)35)
- Have active suicidal ideation (PHQ-9 item #9)35
- Self-report history of cognitive and psychiatric conditions
- Lack of access to the internet/phone (mode of focus group discussions-via Zoom)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06909526 · STUDY00007906