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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HL175286-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-Stress Management Group | Experimental | Participants in this group will receive VR intervention for up to 6 months |
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| Education Control Group | Active Comparator | Participants in this group will be exposed to standard care through educational materials for up to 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judite Blanc, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000091702 | Intersectional Framework |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| 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. |
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| Baseline and up to 12 months |
Sleep will be assessed using actigraphy measured in hours.
| Baseline and up to 12 months |
| Change in blood pressure | Measured by millimeter of mercury | Baseline and up to 3 months after intervention |