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Completed

NCT Number: NCT06079840

Mindfulness Based Stress Reduction App

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.

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Key information

Conditions

Stress Reduction

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friends Research Institute

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

mindfulness-based stress reduction app

Device

mobile application (app) for caregivers

Primary outcomes

  1. Perceived caregiver stress

    Time frame: Up to 12 weeks

    The degree to which stressful situations occurred during a specific period of time.

  2. Caregiver self-compassion

    Time frame: Up to 12 weeks

    Caregiver self-kindness, common humanity, mindfulness, self-judgment, isolation, and over-identification during a specific period of time.

  3. Caregiver-care recipient relationships

    Time frame: Up to 12 weeks

    The degree to which the caregiver feels close to the care recipient

  4. Caregiver burden

    Time frame: Up to 12 weeks

    An assessment of various dimensions of caregiver burden (e.g., isolation, relationship strain, privacy, social life, and health).

  5. Caregiver depressive and anxiety symptoms

    Time frame: Up to 12 weeks

    An assessment of caregiver clinical symptoms of depression and anxiety.

Secondary outcomes

  1. Stigma and discrimination

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

COG Analytics

Other

Collaborators

  • Friends Research Institute, Inc.

Registry information

Official study title

Mindfulness Based Stress Reduction App for African American Caregivers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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