StressNCT06544902
Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women - Realist Women Study
A study testing VR Stress Management in people with Stress and Hypertension, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress, Hypertension
- What is being tested?
- VR Stress Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of psychosis disorders
- absence of vision and cognitive impairment
- absence of epilepsy disorders
- absence of motion sickness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Stress, Hypertension
- Being tested
- VR Stress Management, Education Control
- Keywords
- Intersectional Framework
- Medical subject headings
- Hypertension, Intersectional Framework
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Stress ManagementOther
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-Stress Management Group | Experimental | Participants in this group will receive VR intervention for up to 6 months Receives: 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. Receives: Behavioral: Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stress as measured by Perceived Stress Scale (PSS)
scores ranging from 0 (no symptoms) to 40 (highest severity).
Measured: 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.
Measured: 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."
Measured: 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).
Measured: 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).
Measured: 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
Measured: Baseline and up to 12 months
Secondary outcomes (3)
Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC)
Scores range from 0-40 higher scores indicate higher resiliency
Measured: 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.
Measured: Baseline and up to 12 months
Change in blood pressure
Measured by millimeter of mercury
Measured: Baseline and up to 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start13 May 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Judite Blanc, University of Miami
- Investigators
- Judite Blanc, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544902
- Sponsor's protocol ID
- 20240402
- Other IDs
- 1K01HL175286-01
- Status last verified
- May 2026
- First submitted
- 5 Aug 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women
- ClinicalTrials.gov ID
- NCT06544902
- Acronym / sponsor ID
- 20240402
- Conditions
- Stress, Hypertension
- Keywords
- Intersectional Framework
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 May 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-Stress Management Group | Experimental | Other: VR Stress ManagementParticipants in this group will receive VR intervention for up to 6 months |
| Education Control Group | Active comparator | Behavioral: Education ControlParticipants in this group will be exposed to standard care through educational materials for up to 6 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- History of psychosis disorders
- absence of vision and cognitive impairment
- absence of epilepsy disorders
- absence of motion sickness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Stress ManagementRealist 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. | Other | VR-Stress Management Group |
| Education ControlParticipants 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. | Behavioural | Education Control Group |
Primary outcome
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).
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.
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."
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).
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).
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judite Blanc, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Stress Management in people with Stress and Hypertension, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stress as measured by Perceived Stress Scale (PSS) (time frame: Baseline and up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.