Mindfulness Based Stress Reduction App

NCT ID: NCT06079840

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2025-12-19

Brief Summary

African American caregivers of people living with HIV/AIDS (PLWHA) have unique needs because they are more likely to experience stressors related to intersecting sources of stigma, discrimination, and caregiving burdens specifically associated with caregiving for PLWHA. The proposed project will enhance and finalize Phase I app development and evaluate its effectiveness in a randomized controlled trial. The project has high public health significance because of its potential to provide an accessible, easy to use mindfulness-based support tool for African American caregivers that could reduce stress, mitigate the harm of intersecting stigmas, and strengthen the caregiver-care recipient relationship.

Detailed Description

Building upon prior research regarding mindfulness-based stress reduction interventions, during Phase I, we successfully developed a prototype mobile application (app) for caregivers entitled Mindfulness Based Stress Reduction for African American Caregivers (MBSR-AAC). Based on the Health Stigma and Discrimination Framework, components of the app focus on decreasing stress associated with intersecting sources of stigma, discrimination, and caregiving burdens specifically associated with caregiving for people living with HIV/AIDS (PLWHA). In the present Phase II SBIR study, we will build on Phase I findings to incorporate research-driven enhancements to the app, conduct a feasibility trial of the enhanced app, and conduct a randomized clinical trial to examine the effectiveness of the app in reducing caregiver stress. If proven to be effective, the MBSR-AAC app could have a positive impact on the well-being of African American caregivers that serve as a critical pillar of support for many PLWHA.

Conditions

Stress Reduction

Study Design

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

Study Groups

MBSR-AAC app

Participants will receive the MBSR-AAC app for 8-weeks.

Group Type: EXPERIMENTAL

mindfulness-based stress reduction app

Intervention Type: DEVICE

mobile application (app) for caregivers

Comparison

Participants will receive information regarding caregiver services and resources for 8-weeks.

Group Type: ACTIVE_COMPARATOR

mindfulness-based stress reduction app

Intervention Type: DEVICE

mobile application (app) for caregivers

Interventions

mindfulness-based stress reduction app

mobile application (app) for caregivers

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18 or older
• African American
• Currently a main unpaid caregiver (defined as providing emotional, physical, and financial support) to a person living with HIV/AIDS.

Exclusion Criteria

• Inability to provide informed consent (e.g., compromised comprehension).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Friends Research Institute, Inc.

OTHER

Sponsor Role: collaborator

COG Analytics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven B Carswell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

COG Analytics

Locations

Friends Research Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

2R44AG071168-02

Identifier Type: NIH

Identifier Source: org_study_id

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