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临床试验/NCT04193605
NCT04193605已完成不适用

Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Feasibility Intervention Measure

研究概览

简要总结

The investigator propose to culturally adapt the mindfulness-based stress reduction (MSBR) intervention for Black/African American women living with HIV (WLWH) to reduce stress and enhance HIV self-care behaviors and viral load (VL) suppression, which has the potential to attenuate prominent racial and gender disparities experienced by Black WLWH in the US. Specifically, the investigator aims to 1) culturally adapt the MBSR intervention for Black WLWH using ADAPT-ITT; 2) pre-pilot the adapted intervention via an open non-randomized pilot study to further refine the culturally adapted intervention; and 3) conduct a 2-armed randomized pilot test of the behavioral intervention compared to standard of care to assess the feasibility and acceptability the adapted MBSR intervention for Black WLWH. The investigator hypothesis that the adapted intervention will be feasible and acceptable to member of the target population.

研究设计

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

入排标准

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

入选标准

  • Cisgender females
  • HIV seropositive
  • 18 years of age or older
  • English speaking
  • An active patient at the local HIV ambulatory clinic in Alabama.

排除标准

  • Non-English speaking
  • Appear temporarily impaired (e.g., intoxicated)
  • Not willing to or legally unable to provide informed consent.

结局指标

主要结局

Feasibility Intervention Measure

时间窗: Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.

Feasibility was measured using a four-item feasibility of intervention measure. Each item is scored using a Likert-like scale ranging from "1" completely disagree to "5" completely agree. Higher scores indicate greater feasibility. The minimum total score is 4 points, and the maximum total score is 20.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Crystal C. Lambert

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

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