Using Mobile Stress Management to Reduce Hypertension in African American Men

Официальное название

Reducing Hypertension Among African American Men: A Mobile Stress Management Intervention to Address Health Disparities

Обзор

The goal of this clinical trial is to learn whether a smartphone-based stress management program can reduce blood pressure and perceived stress in Black men with hypertension. The main questions it aims to answer are: Does a mobile cognitive-behavioral stress management intervention (m-CBSMi) reduce systolic and diastolic blood pressure more than a standard online stress management course over 6 months? Does the m-CBSMi reduce perceived stress more than a standard online stress management course over 6 months? Researchers will compare participants assigned to the m-CBSMi - a culturally tailored program delivered via text message and video - to participants assigned to the "Diploma in Stress Management" course on Alison.com, to see if the m-CBSMi produces greater improvements in blood pressure and stress outcomes. Participants will: Complete a phone-based survey at baseline and again at 6 months Attend two in-person blood pressure measurement visits at the partnering clinic, one at baseline and one at 6 months Complete their assigned stress management program (m-CBSMi or the Alison.com course) over 3 months, delivered via smartphone

Вмешательства

• Поведенческое mobile cognitive behavioral stress management intervention
  A culturally tailored, smartphone-delivered cognitive-behavioral stress management intervention (m-CBSMi) for Black men with hypertension. The m-CBSMi consists of 11 video-based sessions covering the stress-hypertension relationship, the impact of racial discrimination on stress, and evidence-based coping strategies. Sessions 2-11 each introduce a new relaxation technique (e.g., diaphragmatic breathing, progressive muscle relaxation, mindfulness meditation), which participants practice via audio
• Поведенческое Diploma in Stress Management course
  A publicly available, online stress management course ("Diploma in Stress Management") offered by Alison.com, one of the world's largest free learning platforms. The course consists of 11 video-based modules covering causes of stress, the link between stress and physical health, the role of thoughts and emotions in stress responses, and relaxation techniques. Three modules are designated as core content for this study: Module 1 (Introduction to Stress), Module 7 (Roles of Thoughts, Beliefs, and

Первичные конечные точки

• Change from Baseline in Mean Seated Systolic and Diastolic Blood Pressure at 6 Months [Срок оценки: Baseline and 6 months]

Вторичные конечные точки (4)

• Change from Baseline in Perceived Stress at 6 Months [Срок оценки: Baseline and 6 months]
• Change from Baseline in Coping Strategies at 6 Months [Срок оценки: Baseline and 6 months]
• Change from Baseline in Coping Self-Efficacy at 6 Months [Срок оценки: Baseline and 6 months]
• Change from Baseline in Mindfulness at 6 Months [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

• African American/Black
• documented diagnosis of hypertension
• documented blood pressure recorded at systolic BP 130+ mmHg or diastolic BP 80+ mmHG
• reliable access to a smartphone capable of receiving text messages and streaming video
• patient at the study's participating clinic so that study staff can confirm blood pressure history and complete required blood pressure measurements

Критерии исключения

\-

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• FMCS — Washington D.C.

Идентификаторы

NCT: NCT07594808 · R44MD017106 · R44MD017106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗