Using Mobile Stress Management to Reduce Hypertension in African American Men

Official title

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

Overview

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

Interventions

• Behavioral 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
• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (4)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 1 center

• FMCS — Washington D.C.

Identifiers

NCT: NCT07594808 · R44MD017106 · R44MD017106

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗