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

NCT06544902 | Enrolling By Invitation

• 2 other identifiers: 202404021K01HL175286-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Hypertension

Keywords

Intersectional Framework

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC)

  Baseline and up to 12 months

• Change in objective sleep health as measured by Sleep Health Objective

  Baseline and up to 12 months

• Change in blood pressure

  Baseline and up to 3 months after intervention

Study Arms (2)

VR-Stress Management Group

EXPERIMENTAL

Participants in this group will receive VR intervention for up to 6 months

Other: VR Stress Management

Education Control Group

ACTIVE COMPARATOR

Participants in this group will be exposed to standard care through educational materials for up to 6 months.

Behavioral: Education Control

Interventions

VR Stress Management OTHER

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.

VR-Stress Management Group

Education Control BEHAVIORAL

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.

Education Control Group

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hypertension; Intersectional Framework

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Study Officials

• Judite Blanc, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: May 13, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)