Mindfulness Based Stress Reduction App

Not Applicable

Recruiting

• Conditions: Stress Reduction

• Registration Number: NCT06079840
• Lead Sponsor: COG Analytics

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.

Study Timeline

• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-08
• Study First Posted: 2023-10-12
• Study Start: 2025-03-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-12-15
• Study Completion: 2026-03-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Stigma and discrimination	Up to 12 weeks	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.

Trial Locations

Locations (1)

Friends Research Institute; 🇺🇸 Baltimore, Maryland, United States