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NCT Number: NCT06811896

Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

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.

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Key information

Conditions

Stress Blood Pressure Cardiovascular Diseases Cardiovascular Diseases (CVD)

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Jenni Wise, PhD, MSN

CONTACT

[email protected]

2059969459

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • severe mental illness
  • not being willing able to provide informed consent
  • not willing or able to attend study visits

Treatment and study plan

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

Primary outcomes

  1. Change in blood pressure at baseline, week 8, and week 20

    Time frame: baseline - week 8 - week 20

    Measure blood pressure at baseline, end of intervention, and at 12-week follow-up

  2. Change in Center for Epidemiological Studies Depression Scale Score

    Time frame: baseline - week 8 - week 20

    Higher score indicates more depressive symptoms (0-60 Range)

  3. Change in Generalized Anxiety Disorder-7 Scale Score

    Time frame: baseline - week 8 - week 20

    Higher scores indicate greater symptoms of anxiety (0-21 Range)

  4. Changes in Perceived Stress Scale Scores

    Time frame: baseline - week 8 - week 20

    Higher scores indicate greater perceived stress (0 - 40 Range)

  5. Changes in Connor-Davidson Resilience Scale

    Time frame: baseline - week 8 - week 20

    Higher scores indicate greater resilience (0-100 Range)

Study contacts

Contact information is provided by the study sponsor or research team.

Jenni Wise, PhD, MSN

CONTACT

[email protected]

2059969459

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 6, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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