Using Mobile Stress Management to Reduce Hypertension in African American Men

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
ISA Associates, Inc.
Study ID
NCT07594808
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: mobile cognitive behavioral stress management intervention (m-CBSMi)
    Experimental group participants will have access to the m-CBSMi
  • Active Comparator: Diploma in Stress Management course
    Control group participants will have access to the Diploma in Stress Management course on the Alison.com e-learning platform

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIP
FMCSWashington D.C.District of Columbia20020

Find similar trials in Washington D.C., DC

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
FMCS· Washington D.C., DC

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