The COMParing App Support Strategies 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: Introductory Coaching Session, Introductory Information Session, On-Demand Email Support, Microsupport.
- Кому может быть актуально
- Состояния в реестре: Depression, Anxiety. Базовые параметры: 18 лет — 65 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
The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.
Подробное описание
Participants will be randomly assigned to various support conditions that vary across three binary factors,
1. Coaching session vs no coaching 2. On-demand email support (Yes/No) 3. Microsupport messages (Yes/No)
Participants will be screened for eligibility using a web-based screener that assesses inclusion and exclusion criteria. Eligible participants will receive a study overview and will have the option to go through an online consent process. After giving consent, participant will receive a text message to assess their ability to receive text messages and tab on a link embedded in the text message. Those who failed to go through this process will be screened out.
Participants consented will complete a baseline survey consisting of a series of questionnaires and daily check-in assessment sent to their phone. Only those who successfully complete the baseline survey and the first daily check-in survey will advance in the study. Participants will schedule a meeting with our study staff member after completing the baseline survey and first daily check-in survey. They will be assessed through questionnaires at baseline, weekly during the 4-week intervention period, and at 6-month follow-up. They will also complete daily check-in survey twice a day throughout the intervention.
Вмешательства
- Другое Introductory Coaching Session
Participant is randomized to receive a 30-minute meditation coaching session - Другое Introductory Information Session
Participant is randomized to receive a 30-minute information session - Другое On-Demand Email Support
email support throughout the 4 week intervention period - Другое Microsupport
Text message microsupport throughout the 4 week intervention period
Первичные конечные точки
- Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) Score [Срок оценки: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Anxiety Measured from Evening Daily Diary Items [Срок оценки: Daily through the Intervention Period (up to 4 weeks)]
- Depression Measured from Evening Daily Diary Items [Срок оценки: Daily through the Intervention Period (up to 4 weeks)]
Вторичные конечные точки (12)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Depression [Срок оценки: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- PROMIS Toolbox Meaning and Purpose Score [Срок оценки: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- NIH Toolbox Loneliness Score [Срок оценки: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Beck's Depression Inventory (BDI) Item 9 Score [Срок оценки: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Five Facet Mindfulness Questionnaire (Awareness subscale) Score [Срок оценки: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Experiences Questionnaire Decentering subscale Score [Срок оценки: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Healthy Minds Index (HM Index) - Awareness Score [Срок оценки: baseline, week 4, 6-month follow up]
- Healthy Minds Index (HM Index) - Connection Score [Срок оценки: baseline, week 4, 6-month follow up]
- Healthy Minds Index (HM Index) - Insight Score [Срок оценки: baseline, week 4, 6-month follow up]
- Healthy Minds Index (HM Index) - Purpose Score [Срок оценки: baseline, week 4, 6-month follow up]
- Growth Mindset Scale Adapted for Well-being Score [Срок оценки: baseline, week 4, 6-month follow up]
- Digital Working Alliance Inventory (DWAI) Score [Срок оценки: week 1, week 2, week 3, week 4]
Критерии участия
Критерии включения
- Elevated symptoms of depression and/or anxiety (PHQ-9 greater than or equal to 10, GAD-7 greater than or equal to 10)
- Proficiency in English
- Access to a smartphone and internet
- Ability to receive text messages
Критерии исключения
- Non-US citizen or legal resident (green card holder)
- History of psychosis or mania
- Suicidal ideation or thoughts of self-harm indicated by PHQ9 item 9 and BDI item 9
- Individuals who do not provide the information required for GUID generation
- Previous participation
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
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Center for Healthy Minds — Madison
Идентификаторы
NCT: NCT07278466 · 2025-1444 · Protocol Version 4/2/2026 · EDUC/COUNSELING PSYCH · 1R01MH139512-01