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Enrolling by Invitation

NCT Number: NCT06544902

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

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.

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Key information

Conditions

Stress Behavior Cardiovascular Diseases Hypertension Intersectional Framework Social Behavior Vascular Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in stress as measured by Perceived Stress Scale (PSS)

    Time frame: Baseline and up to 12 months

    scores ranging from 0 (no symptoms) to 40 (highest severity).

  2. Change in discrimination as measured by Intersectional Discrimination Index (InDI)

    Time frame: Baseline and up to 12 months

    scores ranging from 0 to 4; higher scores indicate greater anticipated intersectional discrimination.

  3. Change in Traumatic stress as measured by Life Events Checklist

    Time frame: Baseline and up to 12 months

    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."

  4. Change in stress as measured by the chronic stress scale

    Time frame: Baseline and up to 12 months

    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).

  5. Change in stress as measured by the Stress in Context (SIC) Questionnaire

    Time frame: Baseline and up to 12 months

    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).

  6. Change in stress as measured by the Giscombe Superwoman Schema Questionnaire

    Time frame: Baseline and up to 12 months

    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

Secondary outcomes

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

    Time frame: Baseline and up to 12 months

    Scores range from 0-40 higher scores indicate higher resiliency

  2. Change in objective sleep health as measured by Sleep Health Objective

    Time frame: Baseline and up to 12 months

    Sleep will be assessed using actigraphy measured in hours.

  3. Change in blood pressure

    Time frame: Baseline and up to 3 months after intervention

    Measured by millimeter of mercury

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 9, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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