Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06811896
Status
Recruiting
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Conditions

  • Blood Pressure
  • Cardiovascular Diseases (CVD)
  • Stress

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stress Management and Resiliency Training Program — BEHAVIORAL
    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.
  • Usual Care — OTHER
    Usual social and clinical services provided to patients at the recruiting clinic

Study Details

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.

Key Dates

Start date
May 14, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Control
    Usual Care
  • Other: Intervention
    Adapted Intervention, Previously Established

Primary Outcome Measure

Change in blood pressure at baseline, week 8, and week 20 [ Time Frame: baseline - week 8 - week 20 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Jenni Wise, PhD, MSN
[email protected]
2059969459

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By research site
University of Alabama at Birmingham· Birmingham, AL

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