CClinicalTrials.gg
RecruitingNCT06811896Updated Sep 28, 2026

Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

An interventional study of Stress Management and Resiliency Training Program and Usual Care in Stress, Blood Pressure and Cardiovascular Diseases (CVD), sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Stress
  • Blood Pressure
  • Cardiovascular Diseases (CVD)

Keywords

  • stress
  • resiliency
  • meditation
  • blood pressure
  • cardiovascular risk
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. severe mental illness
  2. not being willing able to provide informed consent
  3. not willing or able to attend study visits
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Other
    Control

    Usual Care

    Other: Usual Care

  • Other
    Intervention

    Adapted Intervention, Previously Established

    Behavioral: Stress Management and Resiliency Training Program

Interventions

  • BehavioralStress 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.

  • OtherUsual Care

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

05

What researchers measure

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

  5. Changes in Connor-Davidson Resilience Scale

    Higher scores indicate greater resilience (0-100 Range)

    Time frame: baseline - week 8 - week 20

06

Study locations

1 of 1 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06811896
Lead sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Jenni Wise (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Feb 6, 2025
Start date
May 14, 2025
Primary completion
Apr 2027 (estimated)
Completion
Apr 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Jenni Wise, PhD, MSN
Contact
jmwise@uab.edu
2059969459

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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