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Идёт набор NCT06811896

Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

Без фазы С лечением Stress Blood Pressure Cardiovascular Diseases (CVD)

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: Stress Management and Resiliency Training Program, Usual Care.
Кому может быть актуально
Состояния в реестре: Stress, Blood Pressure, Cardiovascular Diseases (CVD). Базовые параметры: от 18 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
США
Следующий шаг
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Официальное название

Adapting and Piloting a Stress Management Intervention to Reduce Cardiovascular Disease Risk Among Women Living With HIV

Обзор

Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with HIV in the South negatively contribute to cardiovascular disease disparities through their impact on stress. The Stress Management and Resiliency Training (SMART) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. While the SMART program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with HIV in the South, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. The purpose of this study is to adapt the evidence-based SMART program in consideration of the needs and contexts of women living with HIV in the Southern US and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.

Вмешательства

  • Поведенческое Stress Management and Resiliency Training Program
    The Stress Management and Resiliency Training Intervention is an evidence-based intervention to reduce physiologic responses to stress that may contribute to cardiovascular disease risk. The intervention is typically delivered over an 8-week period and works to decrease stress responses by improving psychological resiliency to structural and social stressors and decreasing sympathetic nervous system activation. Eliciting the relaxation response through meditation, mindfulness, and autogenic trai
  • Другое Usual Care
    Usual social and clinical services provided to patients at the recruiting clinic

Первичные конечные точки

  • Change in blood pressure at baseline, week 8, and week 20 [Срок оценки: baseline - week 8 - week 20]
  • Change in Center for Epidemiological Studies Depression Scale Score [Срок оценки: baseline - week 8 - week 20]
  • Change in Generalized Anxiety Disorder-7 Scale Score [Срок оценки: baseline - week 8 - week 20]
  • Changes in Perceived Stress Scale Scores [Срок оценки: baseline - week 8 - week 20]
  • Changes in Connor-Davidson Resilience Scale [Срок оценки: baseline - week 8 - week 20]

Критерии участия

Критерии включения

  • cis-gender females at least 18 years of age
  • HIV-seropositive and a patient of the recruiting clinic
  • English speaking

Критерии исключения

  • severe mental illness
  • not being willing able to provide informed consent
  • not willing or able to attend study visits

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Alabama at Birmingham — Birmingham

Идентификаторы

NCT: NCT06811896 · IRB-300012154 · 1K23HL170836-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗