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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Blood Pressure; Cardiovascular Diseases (CVD)
• Intervention / Treatment: Other: Usual Care; Behavioral: Stress Management and Resiliency Training Program

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenni Wise, PhD, MSN; Phone Number: 2059969459; Email: jmwise@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Jenni Wise, PhD, MSN; Phone Number: 2059969459; Email: jmwise@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Usual Care	Other: Usual Care; Usual social and clinical services provided to patients at the recruiting clinic
Other: Intervention; Adapted Intervention, Previously Established	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: cardiovascular risk; meditation; stress; blood pressure; resiliency
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB-300012154; 1K23HL170836-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No