Mindfulness Based Stress Reduction App

Stress Reduction Clinical Trial

Official title:

Mindfulness Based Stress Reduction App for African American Caregivers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079840
• Other study ID #: 2R44AG071168-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2023
• Source: COG Analytics
• Contact: Steven B Carswell, Ph.D.
• Phone: 410-570-7213
• Email: sbcarswell[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Stress Reduction

Intervention

Device:
• mindfulness-based stress reduction app
mobile application (app) for caregivers

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
COG Analytics	Friends Research Institute, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived caregiver stress	The degree to which stressful situations occurred during a specific period of time.	Up to 12 weeks
Primary	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
Primary	Caregiver-care recipient relationships	The degree to which the caregiver feels close to the care recipient	Up to 12 weeks
Primary	Caregiver burden	An assessment of various dimensions of caregiver burden (e.g., isolation, relationship strain, privacy, social life, and health).	Up to 12 weeks
Primary	Caregiver depressive and anxiety symptoms	An assessment of caregiver clinical symptoms of depression and anxiety.	Up to 12 weeks
Secondary	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