The Advancing Dynamic And Personalized Training Study
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: Healthy Minds Program (HMP) app.
- Кому может быть актуально
- Состояния в реестре: Well-Being, Psychological. Базовые параметры: от 18 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
This study aims to enhance the Healthy Minds Program (HMP) app by developing and testing a personalized, data-driven approach to optimize long-term well-being. 1100 participants will be enrolled and on study for up to 4 months (4 week intervention plus 3 month follow-up).
Подробное описание
Participants will be randomly assigned to various training conditions that vary across six factors. Each of the six factors is binary ("yes" vs. "no"), and for each factor there is a 50 percent probability of assignment to either level.
1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no)
Participants will take surveys at baseline, weekly through the 4-week intervention, and 3-month follow-up.
Вмешательства
- Другое Healthy Minds Program (HMP) app
All participants will complete baseline surveys, weekly questionnaires (for 4 weeks) through the HMP app intervention, and will be surveyed again at 3-months post-intervention. Participants are randomized to each of the following binary conditions. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the
Первичные конечные точки
- Change in PHQ-9 [Срок оценки: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
Вторичные конечные точки (12)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression [Срок оценки: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- Change in PROMIS Anxiety Score [Срок оценки: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- Acceptability of Intervention Measure [Срок оценки: week 4 (of intervention period)]
- Change in Growth Mindset Scale for Well-Being [Срок оценки: Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- HMP engagement measure [Срок оценки: Week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- Change in Cannabis Use Disorder Identification Test - Revised (CUDIT-R) [Срок оценки: Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- Change in Alcohol Use Disorders Identification Test (AUDIT) [Срок оценки: Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- Change in Healthy Minds Index (HMI) Score [Срок оценки: Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- Change in PROMIS Global Health Score [Срок оценки: Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- Change in Ruminative Response Scale (RSS) Score [Срок оценки: Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- Change in Big Five Inventory-2 Extra Short Form (BFI-2-XS) [Срок оценки: Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
- Change in Mindfulness Adherence Questionnaire (MAQ) [Срок оценки: Week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)]
Критерии участия
Критерии включения
- Elevated symptoms of depression (PHQ-9 greater than or equal to 5)
- proficiency in English
- access to a smartphone and internet
- ability to receive text messages
Критерии исключения
- Prior experience with meditation
- Prior use of the Healthy Minds Program app
- History of psychosis or mania
- Plans to travel in the next six weeks
- Suicidal ideation or thoughts of self-harm indicated by PHQ-9 item 9 and BDI item 9
- Failure to select the correct code word mentioned in the welcome video
- Not a US citizen
- Non-permanent resident
- Self-identification as artificial intelligence (AI)
- Has a hearing impairment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- Center for Healthy Minds — Madison
Идентификаторы
NCT: NCT07051330 · 2025-0660 · A171600