Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

NCT06811896 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-26

No results posted yet for this study

Summary

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.

Conditions

  • Stress
  • Blood Pressure
  • Cardiovascular Diseases (CVD)

Interventions

BEHAVIORAL

Stress Management and Resiliency Training Program

The Stress Management and Resiliency Training Intervention is an evidence-based intervention to reduce physiologic responses to stress that may contribute to cardiovascular disease risk. The intervention is typically delivered over an 8-week period and works to decrease stress responses by improving psychological resiliency to structural and social stressors and decreasing sympathetic nervous system activation. Eliciting the relaxation response through meditation, mindfulness, and autogenic training are core components.

OTHER

Usual Care

Usual social and clinical services provided to patients at the recruiting clinic

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2027-04-30
Completion
2028-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06811896 on ClinicalTrials.gov