Using Mobile Stress Management to Reduce Hypertension in African American Men

NCT07594808 | Not Yet Recruiting Phase 2

• 1 other identifier: R44MD017106
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Mean Seated Systolic and Diastolic Blood Pressure at 6 Months

  Blood pressure will be assessed using a clinically validated upper-arm oscillometric device following a standardized office measurement protocol. After a 5-minute seated rest, three readings will be taken at 1-minute intervals; the average of the three readings will serve as the study value. Systolic and diastolic blood pressure will each be analyzed as separate continuous outcomes. Lower values indicate better outcomes.

  Baseline and 6 months

Secondary Outcomes (4)

• Change from Baseline in Perceived Stress at 6 Months

  Baseline and 6 months

• Change from Baseline in Coping Strategies at 6 Months

  Baseline and 6 months

• Change from Baseline in Coping Self-Efficacy at 6 Months

  Baseline and 6 months

• Change from Baseline in Mindfulness at 6 Months

  Baseline and 6 months

Study Arms (2)

mobile cognitive behavioral stress management intervention (m-CBSMi)

EXPERIMENTAL

Experimental group participants will have access to the m-CBSMi

Behavioral: mobile cognitive behavioral stress management intervention

Diploma in Stress Management course

ACTIVE COMPARATOR

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

Behavioral: Diploma in Stress Management course

Interventions

mobile cognitive behavioral stress management intervention BEHAVIORAL

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-narrated exercises. Content is delivered through embedded video links sent via text message, along with psychoeducational and motivational texts. Participants are encouraged to complete one session per week over 3 months and to revisit relaxation techniques between sessions. The program is fully self-paced and accessible on any smartphone capable of receiving texts and streaming video.

Also known as: m-CBSMi

mobile cognitive behavioral stress management intervention (m-CBSMi)

Diploma in Stress Management course BEHAVIORAL

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 Emotions), and Module 8 (Relaxation and Cognitive Techniques). Participants are asked to complete these three core modules within 3 months and are encouraged to complete remaining modules as time allows. Weekly text message reminders are sent throughout the program period. The course is self-paced and accessible via smartphone using study-provided login credentials.

Diploma in Stress Management course

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• ISA Associates, Inc.: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05