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Recruiting NCT06811896

Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

No phase Interventional Stress Blood Pressure Cardiovascular Diseases (CVD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stress Management and Resiliency Training Program, Usual Care.
Who it may be relevant to
Registry conditions: Stress, Blood Pressure, Cardiovascular Diseases (CVD). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 trai
  • Other Usual Care
    Usual social and clinical services provided to patients at the recruiting clinic

Primary outcome measures

  • Change in blood pressure at baseline, week 8, and week 20 [Time frame: baseline - week 8 - week 20]
  • Change in Center for Epidemiological Studies Depression Scale Score [Time frame: baseline - week 8 - week 20]
  • Change in Generalized Anxiety Disorder-7 Scale Score [Time frame: baseline - week 8 - week 20]
  • Changes in Perceived Stress Scale Scores [Time frame: baseline - week 8 - week 20]
  • Changes in Connor-Davidson Resilience Scale [Time frame: baseline - week 8 - week 20]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT06811896 · IRB-300012154 · 1K23HL170836-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗