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Mindfulness Based Stress Reduction App

Mindfulness Based Stress Reduction App for African American Caregivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06079840
Enrollment
100
Registered
2023-10-12
Start date
2025-03-18
Completion date
2025-12-19
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Reduction

Keywords

Digital intervention, Mindfulness, Stress reduction

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.

Interventions

DEVICEmindfulness-based stress reduction app

mobile application (app) for caregivers

Sponsors

Friends Research Institute, Inc.
CollaboratorOTHER
COG Analytics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The evaluation will involve a two-group RCT in which 100 African American informal caregivers of PLWHA, who previously participated in a caregiver study will be randomly assigned to one of two conditions: (1) MBSR-AAC app (n=50): Participants will receive the MBSR-AAC app for 8-weeks; or (2) Comparison (n=50): Participants will receive information regarding caregiver services and resources for 8-weeks. Assessments will be conducted with all participants at baseline and 4-, 8-, and 12-weeks post-baseline.

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Perceived caregiver stressUp to 12 weeksThe degree to which stressful situations occurred during a specific period of time.
Caregiver self-compassionUp to 12 weeksCaregiver self-kindness, common humanity, mindfulness, self-judgment, isolation, and over-identification during a specific period of time.
Caregiver-care recipient relationshipsUp to 12 weeksThe degree to which the caregiver feels close to the care recipient
Caregiver burdenUp to 12 weeksAn assessment of various dimensions of caregiver burden (e.g., isolation, relationship strain, privacy, social life, and health).
Caregiver depressive and anxiety symptomsUp to 12 weeksAn assessment of caregiver clinical symptoms of depression and anxiety.

Secondary

MeasureTime frameDescription
Stigma and discriminationUp to 12 weeksAn assessment of caregiver general feelings of shame, rejection, and avoidance and an assessment of discrimination experiences in the day-to-day lives of caregivers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026