HypertensionPhase 2NCT07594808
Using Mobile Stress Management to Reduce Hypertension in African American Men
A Phase 2 study testing mobile cognitive behavioral stress management intervention and Diploma in Stress Management course in people with Hypertension, run by ISA Associates, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- mobile cognitive behavioral stress management intervention and Diploma in Stress Management course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing Hypertension Among African American Men: A Mobile Stress Management Intervention to Address Health Disparities
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?
Read more
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
- Being tested
- mobile cognitive behavioral stress management intervention, Diploma in Stress Management course
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile cognitive behavioral stress management interventionBehavioural
Also called m-CBSMi
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 courseBehavioural
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 group | Role | What they receive |
|---|---|---|
| mobile cognitive behavioral stress management intervention (m-CBSMi) | Experimental | Experimental group participants will have access to the m-CBSMi Receives: 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 Receives: Behavioral: Diploma in Stress Management course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (4)
Change from Baseline in Perceived Stress at 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.
Measured: Baseline and 6 months
Change from Baseline in Coping Strategies at 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.
Measured: Baseline and 6 months
Change from Baseline in Coping Self-Efficacy at 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.
Measured: Baseline and 6 months
Change from Baseline in Mindfulness at 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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start2 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISA Associates, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594808
- Sponsor's protocol ID
- R44MD017106
- Other IDs
- R44MD017106
- Status last verified
- Jun 2026
- First submitted
- 11 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Hypertension Among African American Men: A Mobile Stress Management Intervention to Address Health Disparities
- ClinicalTrials.gov ID
- NCT07594808
- Acronym / sponsor ID
- R44MD017106
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- ISA Associates, Inc.University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobile cognitive behavioral stress management intervention (m-CBSMi) | Experimental | Behavioral: mobile cognitive behavioral stress management interventionExperimental group participants will have access to the m-CBSMi |
| Diploma in Stress Management course | Active comparator | Behavioral: Diploma in Stress Management courseControl group participants will have access to the Diploma in Stress Management course on the Alison.com e-learning platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile cognitive behavioral stress management interventionAlso: m-CBSMiA 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. | Behavioural | mobile cognitive behavioral stress management intervention (m-CBSMi) |
| Diploma in Stress Management courseA 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. | Behavioural | Diploma in Stress Management course |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mobile cognitive behavioral stress management intervention and Diploma in Stress Management course in people with Hypertension, run by ISA Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Mean Seated Systolic and Diastolic Blood Pressure at 6 Months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.