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临床试验/NCT06079840
NCT06079840已完成不适用

Mindfulness Based Stress Reduction App for African American Caregivers

COG Analytics2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Caregiver self-compassion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Inability to provide informed consent (e.g., compromised comprehension).

研究组 & 干预措施

MBSR-AAC app

Experimental

Participants will receive the MBSR-AAC app for 8-weeks.

干预措施: mindfulness-based stress reduction app (Device)

Comparison

Active Comparator

Participants will receive information regarding caregiver services and resources for 8-weeks.

干预措施: mindfulness-based stress reduction app (Device)

结局指标

主要结局

Caregiver self-compassion

时间窗: Up to 12 weeks

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

Caregiver burden

时间窗: Up to 12 weeks

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

Perceived caregiver stress

时间窗: Up to 12 weeks

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

Caregiver depressive and anxiety symptoms

时间窗: Up to 12 weeks

An assessment of caregiver clinical symptoms of depression and anxiety.

Caregiver-care recipient relationships

时间窗: Up to 12 weeks

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

次要结局

  • Stigma and discrimination(Up to 12 weeks)

研究者

发起方
COG Analytics
申办方类型
Other
责任方
Sponsor

研究点 (2)

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