Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

Not Applicable

Not yet recruiting

• Conditions: Stress; Blood Pressure; Cardiovascular Diseases (CVD)

• Registration Number: NCT06811896
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-06
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States