Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

cis-gender females at least 18 years of age

HIV-seropositive and a patient of the recruiting clinic

English speaking

Disqualifiers

severe mental illness

not being willing able to provide informed consent

not willing or able to attend study visits

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Usual Care

    Other intervention

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

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: ControlOther 1 intervention
Group B: InterventionOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
baseline - week 8 - week 20
2

Change in Center for Epidemiological Studies Depression Scale Score

Higher score indicates more depressive symptoms (0-60 Range)

Time frame
baseline - week 8 - week 20
3

Change in Generalized Anxiety Disorder-7 Scale Score

Higher scores indicate greater symptoms of anxiety (0-21 Range)

Time frame
baseline - week 8 - week 20
4

Changes in Perceived Stress Scale Scores

Higher scores indicate greater perceived stress (0 - 40 Range)

Time frame
baseline - week 8 - week 20

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator