Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

NCT06811896 | Recruiting

• 2 other identifiers: IRB-3000121541K23HL170836-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Blood Pressure; Cardiovascular Diseases (CVD)

Keywords

stress; resiliency; meditation; blood pressure; cardiovascular risk

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Control

OTHER

Usual Care

Other: Usual Care

Intervention

OTHER

Adapted Intervention, Previously Established

Behavioral: Stress Management and Resiliency Training Program

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.

Intervention

Usual Care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cis-gender women for intervention randomization
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Jenni Wise, PhD, MSN

CONTACT

2059969459; jmwise@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)