Меню
Идёт набор NCT06987799

Community-based Approach to Lowering Stress Through Mindfulness

Без фазы С лечением Depression Hypertension

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; CALM-Chicago Study).
Кому может быть актуально
Состояния в реестре: Depression, Hypertension. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Addressing Depression for African American Adults With Hypertension: Applying Community-Engaged Implementation Science

Обзор

The goal of this clinical trial is to test a culturally adapted mindfulness-based stress reduction intervention in a community setting for African American adults with high blood pressure (hypertension) and depression. The main questions it aims to answer are: * Does participation in a culturally adapted mindfulness-based intervention improve depressive symptoms? * Does participation in a culturally adapted mindfulness-based intervention improve blood pressure control? * Is the intervention acceptable, appropriate, and feasible as delivered in a community setting? Participants will: * Participate in an 8-week group-based mindfulness intervention (CALM-Chicago). During intervention sessions, participants will learn about mindfulness and stress management and complete mindfulness-based activities, such as guided deep breathing and meditation. * Complete surveys online * Have their blood pressure measured with a non-invasive blood pressure cuff * Attend 1 focus group (optional)

Вмешательства

  • Поведенческое Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)
    This clinical trial will evaluate the effectiveness of the culturally adapted intervention, CALM-Chicago, in a community setting. CALM-Chicago has been previously used in a clinical setting.

Первичные конечные точки

  • Effectiveness: Depressive Symptom Response [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Effectiveness: Systolic Blood Pressure Response [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Implementation: Acceptability [Срок оценки: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years]
  • Implementation: Appropriateness [Срок оценки: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years]
  • Implementation: Feasibility [Срок оценки: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years]
Вторичные конечные точки (4)
  • Effectiveness: Depressive Symptom Remission [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Effectiveness: Blood Pressure Control [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Effectiveness: Medication Adherence [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Implementation: Fidelity [Срок оценки: Assessed after each intervention group during the clinical trial enrollment and follow-up for up to 3 years]

Критерии участия

Критерии включения

  • ≥18 years old
  • Lives, works, or spends much of their time in the South Side of Chicago neighborhood
  • Self-reports diagnosis of hypertension or high blood pressure by a clinician
  • Endorses elevated depressive symptoms as Patient Health Questionnaire (PHQ)-9 scores ≥10
  • Not taking antidepressant medication or stable on antidepressant medication for ≥6 months as self-reported

Критерии исключения

  • <18 years old
  • Severe mental illness (e.g., bipolar disorder, psychosis)
  • Current suicidal ideation (PHQ-9 item 9) or recent (past 6 months) suicide attempt
  • Unable to provide informed consent or complete study activities in English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The Salvation Army Ray and Joan Kroc Corps Community Center Chicago — Chicago

Публикации

  • Burnett-Zeigler I, Zhou E, Martinez JH, Zumpf K, Lartey L, Moskowitz JT, Wisner KL, McDade T, Brown CH, Gollan J, Ciolino JD, Schauer JM, Petito LC. Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC). Trials. 2023 Feb 17;24(1):115. doi: 10.1186/s13063-022-07012- PMID 36803835

Идентификаторы

NCT: NCT06987799 · STU00215977 · K23HL168234

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗