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临床试验/NCT04000841
NCT04000841已完成不适用

Culturally Responsive Stress Reduction: A Mobile Mindfulness Application to Support Health Promotion for African Americans

IRIS Media Inc2 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2021年2月1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
212
试验地点
2
主要终点
Change in Perceived Stress

研究概览

简要总结

Over a 12-week period the investigators will test whether, compared to the Waitlist-Control (WC) condition, administration of the full CRSR intervention improves participants self-reported outcomes of stress, self-efficacy, mindfulness, use of mindfulness strategies, and knowledge. The investigators also will examine the usability, cultural relevance, and user satisfaction.

详细描述

The proposed intervention, Culturally Responsible Stress Reduction: A Mobile Mindfulness Application to Support Health Promotion for African Americans (CRSR), is designed to encourage the use of mindfulness to mitigate the disproportionate amount of stress-related health disparities facing African Americans. Current mindfulness approaches have been unsuccessful in engaging this population. This proposal aims to bridge this disparity by developing an mHealth (mobile health) mindfulness application ("app") tailored specifically to the cultural values of the African American community.

Mindfulness involves meditative practices that cultivate purposeful and nonjudgmental attention to current thoughts, emotions, and physical sensations in the body. Mindfulness has been incorporated into widely-used interventions, including Acceptance and Commitment Therapy (ACT). The CRSR app will be grounded in ACT and will integrate the convenience of mobile technology with tailored content to allow users to shift from potentially harmful culturally prescribed stress-coping activities (e.g., self-reliance, emotional suppression) to adaptive mindfulness-based stress-coping activities aligned with culturally specific values. This integration of content, backed by theory and empirical evidence, effective instructional delivery, an interdisciplinary development team, and modern communication technology will produce an effective mHealth intervention.

The CRSR app features include guided meditations to connect the user to the present moment and a place of calm through culturally aligned exercises grounded in spirituality, orality, self-empowerment, and resilience; personalized notifications prompting users to reflect and engage with the app; periodic email messages on the importance mindfulness as a way increase control over physical and psychological health; and user-customized reminders.

Phase I included developing a testable prototype of the CRSR app, called Mindful You. The prototype provided functionality for participants to practice mindfulness and was used to test proof of concept, i.e., the feasibility and social acceptability of the CRSR app. Users experienced significantly decreased stress and increased self-efficacy. They also reported increased use of mindfulness behaviors and improved self-regulation. Phase II will iteratively build on the prototype to develop the final product and test its efficacy with a fully-powered randomized controlled trial.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Identifies as African-American
  • Can read, write, and understand English
  • Have a valid email address
  • Owns an iOS or Android mobile device

排除标准

  • 未提供

结局指标

主要结局

Change in Perceived Stress

时间窗: Baseline and 12 weeks

Stress will be assessed using the Perceived Stress Scale (PSS), a 10-item frequency scale that evaluates the amount of stress in one's life.Scale ranges from 1 (never) to 4 (very often) with higher scores indicating more stress, therefore decreases at posttest would indicate better outcomes. The scores are averaged to get a total score on the scale which has good internal reliability (alpha = .90 in Phase I).

次要结局

  • Change in Emotion Regulation(Baseline and 12 weeks)
  • Change in Mindfulness(Baseline and 12 weeks)
  • Change in Attitudes toward Mindfulness(Baseline and 12 weeks)
  • Change in Perceived Behavioral Control(Baseline and 12 weeks)
  • Change in Knowledge of Mindfulness(Baseline and 12 weeks)
  • Change in Mindfulness Behaviors(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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