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Идёт набор NCT06001814

Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV

Без фазы С лечением Hiv Cardiovascular Diseases

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: One-Mind One-Heart, Education.
Кому может быть актуально
Состояния в реестре: Hiv, Cardiovascular Diseases. Базовые параметры: от 50 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

Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation. Systemic inflammation is exacerbated by psychological distress via activating the immune response and driving pro-inflammatory CVD risk behaviors. There is promising evidence to suggest that mindfulness could be an effective intervention to reduce psychological distress and support behaviorally- and inflammatory-mediated CVD risk reduction. This project aims to refine and synthesize mindfulness and behavior change content from evidence-based protocols (mindfulness-based stress reduction and diabetes prevention program) to develop and pilot test a new text message-enhanced intervention called "One Mind One Heart" (OM-OH) using feedback from semi-structured interviews with OPWH in psychological distress (N=20), and my multidisciplinary mentorship team (Aim 1). An open pilot (N=5) with exit interviews and pre-post self-report assessments, will inform the initial acceptability of OM-OH and further refine OM-OH as needed (Aim 2). Finally, a pilot randomized controlled trial (RCT; N=50) will be conducted to a.) evaluate benchmarks of feasibility and acceptability of study methods and refined OM-OH compared to enhanced usual care, and b.) investigate potential for effects on psychological distress, inflammation, and behavioral CVD risk (Aim 3). Findings will provide the foundation for an R01 application to conduct an efficacy trial of OM-OH to reduce inflammatory-mediated CVD risk among OPWH.

Вмешательства

  • Поведенческое One-Mind One-Heart
    One-Mind One-Heart will include mindfulness and behavior change skills to address psychological distress, physical activity, diet, and substance use.
  • Другое Education
    Education will be provided on behavioral cardiovascular disease risk reduction strategies, such as increasing physical activity, reducing salt intake in diet, and reduce/stop alcohol and tobacco-use.

Первичные конечные точки

  • Feasibility of recruitment [Срок оценки: Baseline (pre-intervention)]
  • Feasibility of eligibility criteria [Срок оценки: Baseline (pre-intervention)]
  • Feasibility of randomization [Срок оценки: Pre-intervention]
  • Feasibility of the OM-OM intervention [Срок оценки: Duration of intervention]
  • Feasibility of research assessments [Срок оценки: Duration of intervention; 0 and 12-week follow-up]
  • Feasibility of blood draws [Срок оценки: Baseline; 12-week follow-up]
  • Acceptability of OM-OH intervention [Срок оценки: 0-weeks post-intervention]
  • Acceptability of text-enhanced delivery [Срок оценки: 0-weeks post-intervention]
  • Acceptability of blood draws [Срок оценки: 0- and 12-weeks post-intervention]
Вторичные конечные точки (10)
  • Five Factor Mindfulness Questionnaire (FFMQ) [Срок оценки: 0 and 12-weeks post-intervention]
  • Patient Health Questionnaire - 9 (PHQ-9) [Срок оценки: 0 and 12-weeks post-intervention]
  • Generalized Anxiety Disorder - 7 (GAD-7) [Срок оценки: 0 and 12-weeks post-intervention]
  • Perceived Stress Scale (PSS) [Срок оценки: 0 and 12-weeks post-intervention]
  • HIV/AIDS Stress Scale [Срок оценки: 0 and 12-weeks post-intervention]
  • Alcohol Use Disorder Identification Test - Concise (AUDIT-C) [Срок оценки: 0 and 12-weeks post-intervention]
  • Physical Activity and Sedentary Behavior Questionnaire (PASBQ) [Срок оценки: 0 and 12-weeks post-intervention]
  • Dietary Risk Assessment (DRA) [Срок оценки: 0 and 12-weeks post-intervention]
  • Fagerstrom Test For Nicotine Dependence (FTND) [Срок оценки: 0 and 12-weeks post-intervention]
  • Inflammation Biomarkers [Срок оценки: 0- and 12-weeks post-intervention]

Критерии участия

Критерии включения

  • age ≥50 years
  • clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription
  • viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months
  • current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale \[K10\]) screener)
  • ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol
  • access to cell phone with text messaging capabilities

Критерии исключения

  • non-English-speaking
  • cognitive impairments preventing informed consent
  • untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview

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

США · 1 центр
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT06001814 · 2023P002014 · PA20-206 · 1K23HL167650-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗