Mindfulness Based Stress Reduction App

Mindfulness Based Stress Reduction App for African American Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Stress Reduction
• Intervention / Treatment: Device: mindfulness-based stress reduction app

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Friends Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBSR-AAC app; Participants will receive the MBSR-AAC app for 8-weeks.	Device: mindfulness-based stress reduction app; mobile application (app) for caregivers
Active Comparator: Comparison; Participants will receive information regarding caregiver services and resources for 8-weeks.	Device: mindfulness-based stress reduction app; mobile application (app) for caregivers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived caregiver stress	The degree to which stressful situations occurred during a specific period of time.	Up to 12 weeks
Caregiver self-compassion	Caregiver self-kindness, common humanity, mindfulness, self-judgment, isolation, and over-identification during a specific period of time.	Up to 12 weeks
Caregiver-care recipient relationships	The degree to which the caregiver feels close to the care recipient	Up to 12 weeks
Caregiver burden	An assessment of various dimensions of caregiver burden (e.g., isolation, relationship strain, privacy, social life, and health).	Up to 12 weeks
Caregiver depressive and anxiety symptoms	An assessment of caregiver clinical symptoms of depression and anxiety.	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stigma and discrimination	An assessment of caregiver general feelings of shame, rejection, and avoidance and an assessment of discrimination experiences in the day-to-day lives of caregivers.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: COG Analytics
• Collaborators: Friends Research Institute, Inc.
• Investigators: Principal Investigator: Steven B Carswell, Ph.D., COG Analytics

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Actual): December 19, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: October 8, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Stress reduction; Digital intervention
• Other Study ID Numbers: 2R44AG071168-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No