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

Trial Summary

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 data supports the effectiveness of the Stress Management and Resiliency Training Program treatment for cardiovascular disease?

Research shows that stress management and lifestyle programs can improve heart health by reducing stress and emotional distress, which are risk factors for heart disease. Additionally, stress-relieving programs have been linked to fewer deaths in heart disease patients, suggesting they can be beneficial for heart health. ^{1 2 3 4 5}

Is stress management training safe for people with cardiovascular disease?

Stress management programs, like those using biofeedback, have been used safely in various settings, including workplaces, to improve health behaviors and performance. Additionally, cardiac rehabilitation programs that include stress management components have been shown to reduce mortality and improve health outcomes, suggesting they are generally safe for people with cardiovascular conditions. ^{3 6 7 8 9}

How does the Stress Management and Resiliency Training Program differ from other treatments 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 strategies, which can be delivered online or in-person. Unlike traditional treatments that may focus on medication or physical interventions, SMART aims to improve mental well-being, which can indirectly benefit cardiovascular health. ^{2 10 11 12 13}

What is the purpose of this trial?

Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with HIV in the South negatively contribute to cardiovascular disease disparities through their impact on stress. The Stress Management and Resiliency Training (SMART) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. While the SMART program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with HIV in the South, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. The purpose of this study is to adapt the evidence-based SMART program in consideration of the needs and contexts of women living with HIV in the Southern US and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Stress management approaches to the prevention of coronary heart disease. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Psychological and quality-of-life outcomes from a comprehensive stress reduction and lifestyle program in patients with coronary artery disease: results of a randomized trial. [2009]

3. England pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of psychosocial resilience training for heart health, and the added value of promoting physical activity: a cluster randomized trial of the READY program. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The ischemic heart disease life stress monitoring program: impact on mortality. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Brief strategic therapy in first myocardial infarction patients with increased levels of stress: a randomized clinical trial. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

The Equitable Life Assurance Society program. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: a review of current developments. [2019]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Modern strategies for cardiac rehabilitation after myocardial infarction and percutaneous coronary intervention]. [2020]

9. England pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Assessment of the cardiovascular effects of stress. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Stress Management and Resilience Intervention in a Women's Heart Clinic: A Pilot Study. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Psychological factors and cardiac risk and impact of exercise training programs-a review of ochsner studies. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of a brief meditation-based stress management intervention for patients diagnosed with or at risk for coronary heart disease: a pilot study. [2009]