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

NCT ID: NCT06544902

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-13
• Study Completion Date: 2028-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR-Stress Management Group

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

Group Type: EXPERIMENTAL

VR Stress Management

Intervention Type: OTHER

First Resort (FR) is an eight-week wellness program that comprises 22 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 Group

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

Group Type: ACTIVE_COMPARATOR

Education Control

Intervention Type: 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.

Interventions

VR Stress Management

First Resort (FR) is an eight-week wellness program that comprises 22 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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Judite Blanc

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judite Blanc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

1K01HL175286-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20240402

Identifier Type: -

Identifier Source: org_study_id