Using Mobile Stress Management to Reduce Hypertension in African American Men

ISA Associates, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Hypertension

Treatments: Behavioral: mobile cognitive behavioral stress management intervention; Behavioral: Diploma in Stress Management course

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07594808

R44MD017106 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 135 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

-

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

135 participants in 2 patient groups

mobile cognitive behavioral stress management intervention (m-CBSMi)

Experimental group

Description:

Experimental group participants will have access to the m-CBSMi

Treatment:

Behavioral: mobile cognitive behavioral stress management intervention

Diploma in Stress Management course

Active Comparator group

Description:

Control group participants will have access to the Diploma in Stress Management course on the Alison.com e-learning platform

Treatment:

Behavioral: Diploma in Stress Management course