Skip to content

Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women - Realist Women Study

Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06544902
Enrollment
60
Registered
2024-08-09
Start date
2025-05-13
Completion date
2028-06-30
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Stress

Keywords

Intersectional Framework

Brief summary

The Realist Women Study wants to see if a special program using virtual reality can help Black women deal with stress and improve Black women's heart health. The study team wants to see if using virtual reality (VR) can help with stress of Black women. The investigator will look at things like sleep, stress, and how well the VR works. The investigator also wants to know about any problems Black women might have using virtual reality.

Interventions

OTHERVR Stress Management

Realist Women program is a five-week wellness program that comprises of multiple modules, each lasting between 10 and 20 minutes, participants will complete modules weekly in person. Each module will teach participants about values-based goal setting/ behavioral activation, and cognitive restructuring.

BEHAVIORALEducation Control

Participants in this group will receive one-time educational material regarding stress. The participants can review the material remotely. American Heart Association (AHA) brochures and infographics regarding chronic stress and women's health, heart disease and mental health among black women, healthy for good sleep well, among other useful resources.

Sponsors

University of Miami
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* self-identified as a Black woman * at least 21 years of age * fluency in English * International Classification of Diseases (ICD)10 diagnosis of hypertension * being a South Florida resident * willing to be audio-recorded

Exclusion criteria

* History of psychosis disorders * absence of vision and cognitive impairment * absence of epilepsy disorders * absence of motion sickness.

Design outcomes

Primary

MeasureTime frameDescription
Change in stress as measured by Perceived Stress Scale (PSS)Baseline and up to 12 monthsscores ranging from 0 (no symptoms) to 40 (highest severity).
Change in discrimination as measured by Intersectional Discrimination Index (InDI)Baseline and up to 12 monthsscores ranging from 0 to 4; higher scores indicate greater anticipated intersectional discrimination.
Change in Traumatic stress as measured by Life Events ChecklistBaseline and up to 12 monthsThis self-report checklist screens for potentially traumatic events in an individual's lifetime. Scores range from 1 to 17, higher scores indicate higher traumatic exposures. It consists of 17 questions with responses such as "happened to me," "witnessed it," "learned about it," "part of my job," "not sure," and "doesn't apply."
Change in stress as measured by the chronic stress scaleBaseline and up to 12 monthsThe Chronic Stress Scale is a 51-item scale that evaluates the perceived experience of chronic stress. Scores range from 0 (not true) to 2 (very true).
Change in stress as measured by the Stress in Context (SIC) QuestionnaireBaseline and up to 12 monthsThe SIC Questionnaire is a 21-item survey assessing stress perception in specific contexts (e.g., home, work, social relationships), with scoring from 1 (never) to 4 (usually).
Change in stress as measured by the Giscombe Superwoman Schema QuestionnaireBaseline and up to 12 monthsIt contains 35 statements rated from 0 (not true) to 4 (true all the time) across the 5 subscales. subscale items are summed to create one Super Woman Schema (SWS) total, these categories can be used: 0-35: Low SWS 36-70: Moderate SWS 71-105: High SWS

Secondary

MeasureTime frameDescription
Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC)Baseline and up to 12 monthsScores range from 0-40 higher scores indicate higher resiliency
Change in objective sleep health as measured by Sleep Health ObjectiveBaseline and up to 12 monthsSleep will be assessed using actigraphy measured in hours.
Change in blood pressureBaseline and up to 3 months after interventionMeasured by millimeter of mercury

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJudite Blanc, PhD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026