Skip to content

Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

Adapting and Piloting a Stress Management Intervention to Reduce Cardiovascular Disease Risk Among Women Living With HIV

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06811896
Enrollment
48
Registered
2025-02-06
Start date
2025-05-14
Completion date
2028-04-30
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Cardiovascular Diseases (CVD), Stress

Keywords

stress, resiliency, meditation, blood pressure, cardiovascular risk

Brief 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.

Interventions

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.

OTHERUsual Care

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. cis-gender females at least 18 years of age 2. HIV-seropositive and a patient of the recruiting clinic 3. English speaking

Exclusion criteria

1. severe mental illness 2. not being willing able to provide informed consent 3. not willing or able to attend study visits

Design outcomes

Primary

MeasureTime frameDescription
Change in blood pressure at baseline, week 8, and week 20baseline - week 8 - week 20Measure blood pressure at baseline, end of intervention, and at 12-week follow-up
Change in Center for Epidemiological Studies Depression Scale Scorebaseline - week 8 - week 20Higher score indicates more depressive symptoms (0-60 Range)
Change in Generalized Anxiety Disorder-7 Scale Scorebaseline - week 8 - week 20Higher scores indicate greater symptoms of anxiety (0-21 Range)
Changes in Perceived Stress Scale Scoresbaseline - week 8 - week 20Higher scores indicate greater perceived stress (0 - 40 Range)
Changes in Connor-Davidson Resilience Scalebaseline - week 8 - week 20Higher scores indicate greater resilience (0-100 Range)

Countries

United States

Contacts

Primary ContactJenni Wise, PhD, MSN
jmwise@uab.edu2059969459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026