Clinical trial NCT06079840: Mindfulness Based Stress Reduction App
Official title: Mindfulness Based Stress Reduction App for African American Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Reduction
Keywords: Digital intervention
Mindfulness
Stress reduction
Lead sponsor: COG Analytics
Sponsor class: OTHER
Collaborators: name: Friends Research Institute, Inc.
First posted: 2023-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Perceived caregiver stress
timeFrame: Up to 12 weeks
measure: Caregiver self-compassion
timeFrame: Up to 12 weeks
measure: Caregiver-care recipient relationships
timeFrame: Up to 12 weeks
measure: Caregiver burden
timeFrame: Up to 12 weeks
measure: Caregiver depressive and anxiety symptoms
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Stigma and discrimination
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Friends Research Institute
state: Maryland
Study officials:
affiliation: COG Analytics
name: Steven B Carswell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: