Stress Management for Cardiovascular Disease

Overseen By Jenni Wise, PhD, MSN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 8 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women living with HIV in the Southern US manage stress and lower their risk of heart disease. The study tests an adapted version of the Stress Management and Resiliency Training Program, recognized for improving resilience and reducing stress-related health issues. Participants will either continue their usual care or try this new program. Women with HIV who speak English and receive care at the participating clinic might be a good fit. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance stress management strategies for women with HIV.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on stress management for women living with HIV, so it's best to ask the trial organizers for more details.

What prior data suggests that the Stress Management and Resiliency Training Program is safe for women living with HIV?

Research has shown that the Stress Management and Resiliency Training (SMART) program is generally safe and manageable for most people. In past studies, participants felt significantly less stressed and noticed improvements in their mental health. No major negative effects have been reported from these activities, which use teaching and relaxation methods to reduce stress and anxiety. This suggests the program is quite safe for most people, including those at risk for heart disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stress Management and Resiliency Training Program for cardiovascular disease because it offers a non-drug approach to managing stress, which is a key factor in heart health. Unlike traditional treatments that often focus on medication to control blood pressure and cholesterol, this program emphasizes building mental resilience and coping skills. By teaching patients how to better handle stress, this method aims to address one of the root causes of cardiovascular issues rather than just treating the symptoms. This innovative focus on mental well-being could lead to more holistic and sustainable heart health improvements.

What evidence suggests that the Stress Management and Resiliency Training Program is effective for reducing cardiovascular disease risk among women living with HIV?

Research has shown that the Stress Management and Resiliency Training (SMART) program can lower stress and improve heart health. In this trial, participants will either receive the SMART program or continue with usual care. Studies have found that adding stress management to heart health programs results in less stress and better heart outcomes compared to standard care alone. The SMART program aims to increase psychological resilience, which is linked to a lower risk of heart disease and better overall health. Although researchers have not specifically tested this program on women with HIV in the Southern US, its success in different settings suggests it could help reduce stress-related heart risks for this group. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for women living with HIV in the Southern US, who are at higher risk for cardiovascular disease. It aims to help those dealing with stress-related health issues like high blood pressure and sleep apnea. Participants should be experiencing stressors such as poverty or discrimination that could impact their heart health.

Inclusion Criteria

I am a cisgender woman aged 18 or older.

English speaking

HIV-seropositive and a patient of the recruiting clinic

Exclusion Criteria

Not being willing or able to provide informed consent

Severe mental illness

I cannot or do not want to go to study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the adapted SMART program intervention to reduce stress and mitigate cardiovascular disease risk

8 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in resilience, blood pressure, depression, stress, and anxiety

12 weeks

Assessments at week 20

What Are the Treatments Tested in This Trial?

Interventions

• Stress Management and Resiliency Training Program

Trial Overview The study tests a Stress Management and Resiliency Training (SMART) program against usual care to see if it can improve resilience to stress and reduce the risk of cardiovascular disease in women with HIV. The SMART program will be adapted to fit the cultural context of participants from the South.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Adapted Intervention, Previously Established

Group II: Control Experimental Treatment 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

An individualized stress management training program using biofeedback was shown to improve employee performance, health behaviors, and cognitive functions, demonstrating its efficacy in a workplace setting.

The program yielded a significant cost-benefit ratio, with a return of $5.52 for every dollar invested, highlighting its financial viability and effectiveness in enhancing employee well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Equitable Life Assurance Society program. Manuso, JS.[2019]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4824555/

Enhancing Cardiac Rehabilitation With Stress ... CR enhanced by SMT produced significant reductions in stress and greater improvements in medical outcomes compared with standard CR.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.118.005284?doi=10.1161/CIRCOUTCOMES.118.005284

Stress, Resilience, and Cardiovascular Disease Risk ... Background:Empirical data on the link between stress and cardiovascular disease (CVD) risk among black women is limited.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022399925000807

Insights from the German Gutenberg Health Study This study aimed to examine the associations between psychological resilience, CVD, and all-cause mortality within a large general population cohort. Methods.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10843306/

Relationship between stress and coronary artery disease This review examines the intricate relationship between psychological stress and CAD, drawing from recent research spanning the last 5 to 10 years.

5. brieflands.com brieflands.com/journals/jcrps/articles/137533.pdf

Effects of Stress Management Skills Training on the ... Objectives: To determine the effects of stress management skills training on the resilience of family caregivers of heart failure patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9093702/

Stress Management and Resiliency Training for Healthcare ... Results: Participants experienced a significant reduction in perceived stress (p < 0.001) and significant improvements in global mental health (p = 0.001), ...

7. withpower.com withpower.com/trial/phase-hypertension-1-2025-ba740

Stress Management for Cardiovascular Disease The Stress Management and Resiliency Training (SMART) Program is unique because it focuses on reducing stress and anxiety through educational and relaxation ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001259

Fostering Psychological Safety and Supporting Mental ... Other data show a higher risk of suicide among registered nurses, health technicians, and health care support workers in the United States ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25005897

A Randomized Trial of a Resilience-Building Intervention in ... Resilience scores at 3 months were higher in the treatment group (n = 30, 30.1 ± 8.1) compared to control (n = 35, 28.7 ± 5.8); this difference was not ...