Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

NCT ID: NCT06811896

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2028-04-30

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)

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

Usual Care

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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

Intervention

Adapted Intervention, Previously Established

Group Type: OTHER

Stress Management and Resiliency Training Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jenni Wise

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jenni Wise, PhD, MSN

Role: CONTACT

jmwise@uab.edu

2059969459

Facility Contacts

Jenni Wise, PhD, MSN

Role: primary

jmwise@uab.edu

2059969459

Other Identifiers

1K23HL170836-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300012154

Identifier Type: -

Identifier Source: org_study_id