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Enrolling by Invitation

NCT Number: NCT07594808

Using Mobile Stress Management to Reduce Hypertension in African American Men

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

FMCS

Washington D.C., District of Columbia, 20020, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Other names: 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.

Primary outcomes

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

    Time frame: Baseline and 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.

Secondary outcomes

  1. Change from Baseline in Perceived Stress at 6 Months

    Time frame: Baseline and 6 months

    Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). Participants rate how often they experienced stress-related thoughts and feelings in the past month on a scale from 1 (never) to 5 (very often). The total score will be divided by the number of items to yield a mean item score, resulting in a scale range of 1 to 5, with higher scores indicating greater perceived stress.

  2. Change from Baseline in Coping Strategies at 6 Months

    Time frame: Baseline and 6 months

    Coping will be assessed using a 28-item adapted version of the Brief COPE measuring the frequency of approach-oriented (e.g., active coping, seeking support, positive reframing) and avoidant (e.g., denial, behavioral disengagement, substance use) coping strategies used in the past month. Items are rated from 1 (not at all) to 4 (a lot). The total score will be divided by the number of items to yield a mean item score, resulting in a scale range of 1 to 4. Approach and avoidant coping subscales will be scored separately, with higher scores indicating greater use of each strategy type.

  3. Change from Baseline in Coping Self-Efficacy at 6 Months

    Time frame: Baseline and 6 months

    Coping self-efficacy will be assessed using a 13-item brief version of the Coping Self-Efficacy Scale. Participants rate their confidence in performing specific coping behaviors when things are not going well on a scale from 1 (not at all confident) to 5 (completely confident). The total score will be divided by the number of items to yield a mean item score, resulting in a scale range of 1 to 5, with higher scores indicating greater coping self-efficacy.

  4. Change from Baseline in Mindfulness at 6 Months

    Time frame: Baseline and 6 months

    Mindfulness will be assessed using the 10-item Cognitive and Affective Mindfulness Scale-Revised. Participants rate how often statements about attention, present-moment awareness, emotional acceptance, and non-judgmental observation of thoughts apply to them, using a scale from 1 (never/rarely) to 4 (almost always). The total score will be divided by the number of items to yield a mean item score, resulting in a scale range of 1 to 4, with higher scores indicating greater mindfulness.

Sponsors and collaborators

Lead sponsor

ISA Associates, Inc.

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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