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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension; Stress
• Intervention / Treatment: Behavioral: Education Control; Other: VR Stress Management

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-Stress Management Group; Participants in this group will receive VR intervention for up to 6 months	Other: VR 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.
Active Comparator: Education Control Group; Participants in this group will be exposed to standard care through educational materials for up to 6 months.	Behavioral: Education 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stress as measured by Perceived Stress Scale (PSS)	scores ranging from 0 (no symptoms) to 40 (highest severity).	Baseline and up to 12 months
Change in discrimination as measured by Intersectional Discrimination Index (InDI)	scores ranging from 0 to 4; higher scores indicate greater anticipated intersectional discrimination.	Baseline and up to 12 months
Change in Traumatic stress as measured by Life Events Checklist	This 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."	Baseline and up to 12 months
Change in stress as measured by the chronic stress scale	The 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).	Baseline and up to 12 months
Change in stress as measured by the Stress in Context (SIC) Questionnaire	The 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).	Baseline and up to 12 months
Change in stress as measured by the Giscombe Superwoman Schema Questionnaire	It 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	Baseline and up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Measured by millimeter of mercury	Baseline and up to 3 months after intervention
Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC)	Scores range from 0-40 higher scores indicate higher resiliency	Baseline and up to 12 months
Change in objective sleep health as measured by Sleep Health Objective	Sleep will be assessed using actigraphy measured in hours.	Baseline and up to 12 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Judite Blanc, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Intersectional Framework
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavior; Social Behavior; Hypertension; Intersectional Framework
• Other Study ID Numbers: 20240402; 1K01HL175286-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No