Mobile Stress Management for High Blood Pressure

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Overseen BySamantha L Leaf, PhD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: ISA Associates, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone-based stress management program, known as mobile cognitive behavioral stress management intervention (m-CBSMi), can lower blood pressure and stress levels in Black men with high blood pressure. Researchers seek to compare the effectiveness of this mobile program against a standard online stress management course. Participants will be divided into two groups: one using the mobile program and the other the online course. The trial seeks Black men diagnosed with high blood pressure who have access to a smartphone. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially effective stress management solutions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile cognitive behavioral stress management intervention is safe for Black men with hypertension?

Research shows that cognitive-behavioral therapy (CBT) is generally safe and manageable for participants. Studies have found that CBT programs can effectively lower blood pressure and reduce stress in individuals with hypertension. These programs have been linked to significant decreases in both systolic and diastolic blood pressure.

While specific data on side effects for the mobile version of this therapy (m-CBSMi) is lacking, similar digital health programs have demonstrated good results in managing blood pressure. Participants in these programs have not reported any major safety issues. Based on this evidence, the mobile cognitive-behavioral stress management intervention appears safe for managing blood pressure and stress.12345

Why are researchers excited about this trial?

Researchers are excited about the mobile cognitive behavioral stress management intervention (m-CBSMi) for high blood pressure because it leverages the convenience and accessibility of mobile technology to help manage stress, a key contributor to hypertension. Unlike traditional treatments that mainly focus on medication or lifestyle changes like diet and exercise, this approach offers a digital, behavioral strategy that people can use anytime, anywhere. By combining cognitive behavioral therapy techniques with mobile app technology, m-CBSMi aims to empower users to actively manage their stress levels, potentially reducing blood pressure without additional medication. This method could offer a complementary, user-friendly tool to enhance the effectiveness of existing treatments.

What evidence suggests that this mobile cognitive behavioral stress management intervention is effective for reducing high blood pressure?

Research has shown that cognitive behavioral therapy (CBT) can help lower blood pressure in individuals with hypertension. One study found that CBT treatments reduced the systolic blood pressure by about 8.67 mm Hg. This reduction is significant because even small decreases in blood pressure can lower the risk of heart issues. CBT also reduces stress, which is crucial for managing high blood pressure. Another study found that stress management improved both quality of life and blood pressure in patients. This trial will compare two approaches: the mobile cognitive behavioral stress management intervention (m-CBSMi), which one group of participants will receive, and the Diploma in Stress Management course, which another group will access. Early research suggests that smartphone apps for stress management might also help control high blood pressure.12678

Are You a Good Fit for This Trial?

This trial is for African American/Black men who have high blood pressure (systolic 130+ or diastolic 80+), a formal diagnosis of hypertension, and reliable access to a smartphone that can receive texts and stream video.

Inclusion Criteria

African American/Black
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
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete their assigned stress management program (m-CBSMi or the Alison.com course) over 3 months, delivered via smartphone

12 weeks
2 visits (in-person) for blood pressure measurement, 1 visit (phone-based survey)

Follow-up

Participants are monitored for changes in blood pressure, perceived stress, coping self-efficacy, coping strategies, and mindfulness

6 months
1 visit (phone-based survey)

What Are the Treatments Tested in This Trial?

Interventions

  • Diploma in Stress Management course
  • mobile cognitive behavioral stress management intervention (m-CBSMi)

Trial Overview

The study compares two stress management programs delivered by smartphone: one is a culturally tailored mobile cognitive-behavioral intervention using texts and videos, the other is an online course. Researchers want to see which lowers blood pressure and stress more over six months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: mobile cognitive behavioral stress management intervention (m-CBSMi)Experimental Treatment1 Intervention
Group II: Diploma in Stress Management courseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ISA Associates, Inc.

Lead Sponsor

Trials
6
Recruited
920+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Citations

Effectiveness of cognitive behavioral therapy for hypertension ...

CBT may also have physiological benefits, including reduced stress and increased emotional resilience, which are central to the management of hypertension

Efficacy of cognitive-behavioral stress management ...

The results demonstrated the effectiveness of CBSM group intervention in the improvement of quality of life and blood pressure in the females with hypertension.

The efficacy of cognitive behavioral therapy-based ... - PMC

The main analysis revealed that CBT-based interventions reduced systolic pressure: −8.67 (95% CI: −10.67 to −6.67, P = 0.000); diastolic ...

The efficacy of cognitive behavioral therapy-based ...

CBT-based intervention has a positive effect on health outcomes in patients with hypertension. 2. CBT-based intervention might be more effective for blood ...

Cognitive behavioral therapy for the management of ...

CBT interventions in relation to high blood pressure levels management and hypertension. We located three meta-analyses that explored CBT's ...

Effectiveness of cognitive behavioral therapy for ...

This study examined the effectiveness of an 8-week CBT program in reducing psychological distress among adults with hypertension attending a Nigerian tertiary ...

2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ ...

The rationale for this categorization is based on observational data demonstrating the association between systolic blood pressure (SBP)/diastolic blood ...

The Impact of Digital Intervention Messages Targeting Users ...

Data-driven nudges delivered via a digital health platform were associated with improved BP outcomes among individuals with high BP levels