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Enrolling by invitation NCT06544902

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

No phase Interventional Stress Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR Stress Management, Education Control.
Who it may be relevant to
Registry conditions: Stress, Hypertension. Basic parameters: from 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Change in stress as measured by Perceived Stress Scale (PSS) [Time frame: Baseline and up to 12 months]
  • Change in discrimination as measured by Intersectional Discrimination Index (InDI) [Time frame: Baseline and up to 12 months]
  • Change in Traumatic stress as measured by Life Events Checklist [Time frame: Baseline and up to 12 months]
  • Change in stress as measured by the chronic stress scale [Time frame: Baseline and up to 12 months]
  • Change in stress as measured by the Stress in Context (SIC) Questionnaire [Time frame: Baseline and up to 12 months]
  • Change in stress as measured by the Giscombe Superwoman Schema Questionnaire [Time frame: Baseline and up to 12 months]
Secondary outcome measures (3)
  • Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC) [Time frame: Baseline and up to 12 months]
  • Change in objective sleep health as measured by Sleep Health Objective [Time frame: Baseline and up to 12 months]
  • Change in blood pressure [Time frame: Baseline and up to 3 months after intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06544902 · 20240402 · 1K01HL175286-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗