Mindfulness Based Stress Reduction App

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness Based Stress Reduction App for African American Caregivers

Conditions
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Stress Reduction

Intervention / Treatment
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* Device: mindfulness-based stress reduction app


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR-AAC app<br>Participants will receive the MBSR-AAC app for 8-weeks. | Device: mindfulness-based stress reduction app<br>* mobile application (app) for caregivers<br>|
| Active Comparator: Comparison<br>Participants will receive information regarding caregiver services and resources for 8-weeks. | Device: mindfulness-based stress reduction app<br>* mobile application (app) for caregivers<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital intervention, Mindfulness, Stress reduction