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Meditation Apps for Stress Management in Black Women

2026年9月16日 更新者：Sunny Wonsun Kim, Ph.D、Arizona State University

Feasibility, Acceptability, and Preliminary Effects of Culturally-Adapted and Generic Meditation Apps for Stress Reduction in Middle-Aged Black Women

This randomized remote pilot study will evaluate the feasibility, acceptability, and preliminary effects of two meditation and mindfulness applications among approximately 40 Black women ages 35-64 experiencing moderate to high stress.

Participants will be randomly assigned in a 1:1 ratio to Exhale™, a culturally adapted meditation app designed for Black women, or Levelhead, a general mindfulness app. Participants will be asked to complete at least one session using their assigned app per day, lasting approximately 5 minutes or longer, at least 5 days per week for 4 weeks.

Participants will complete online questionnaires at baseline and after the 4-week intervention. Daily Remind messages and weekly study check-ins will support engagement. Outcomes include recruitment, retention, adherence, assessment completion, satisfaction, usability, perceived stress, race-based stress, sleep, depression, anxiety, cultural relevance, and brief participant feedback.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This study is a two-arm, randomized, fully remote pilot study comparing Exhale™, a culturally adapted meditation application designed for Black women, with Levelhead, a general science-based mindfulness application.

Approximately 40 Black women ages 35-64 who report moderate to high perceived stress will be enrolled. After eligibility screening, informed consent, and completion of baseline questionnaires through REDCap, participants will be randomized in a 1:1 ratio to Exhale™ or Levelhead using the REDCap randomization module.

Participants in both groups will be asked to complete at least one app-based meditation or mindfulness session per day, lasting approximately 5 minutes or longer, at least 5 days per week for 4 weeks. Participants may complete additional or longer sessions but will not be required to make up missed sessions. Daily Remind messages will ask participants whether they completed a session and the approximate number of minutes practiced. Weekly check-ins will provide study reminders and opportunities to request technical assistance.

Remote questionnaires will be administered at baseline and at the end of Week 4. Primary outcomes will assess feasibility and acceptability through recruitment, retention, adherence, assessment completion, satisfaction, and usability. Secondary outcomes will examine preliminary changes in perceived stress, race-based stress, sleep, depression, and anxiety. Cultural relevance and brief open-ended participant feedback will also be collected. Some participants may be invited to complete an optional brief remote exit interview.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Self-identifies as a Black or African American woman
  • Ages 35-64 years
  • Able to read and speak English
  • Perceived Stress Scale-10 screening score greater than 14
  • Has access to a smartphone or tablet with internet access
  • Willing to complete remote baseline and post-intervention assessments
  • Willing to attempt the assigned app-based practice for 4 weeks
  • Willing to receive study communications

Exclusion Criteria:

  • Regular use of meditation or mindfulness applications within the previous 6 months
  • Any prior use of Exhale™
  • Significant hearing impairment that prevents engagement with audio-based application content
  • Self-reported difficulty navigating smartphone applications that would prevent participation

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Exhale™ Meditation App
Participants assigned to Exhale™ will use a culturally adapted meditation application designed for Black women. Participants will be asked to complete at least one meditation session per day, lasting approximately 5 minutes or longer, at least 5 days per week for 4 weeks. Participants will receive daily Remind messages, weekly study check-ins, and remote technical support as needed.
行为的：Exhale™ Meditation App
A culturally adapted meditation application designed for Black women that provides guided meditation and mindfulness content addressing stress, rest, grounding, self-care, and culturally relevant experiences. Participants will manually select sessions and complete approximately 5 minutes or longer of practice at least 5 days per week for 4 weeks.
有源比较器：Levelhead Mindfulness App
Participants assigned to Levelhead will use a general science-based mindfulness application. Participants will be asked to complete at least one mindfulness session per day, totaling approximately 5 minutes or longer, at least 5 days per week for 4 weeks. Participants will receive daily Remind messages, weekly study check-ins, and remote technical support as needed.
行为的：Levelhead Mindfulness App
A general science-based mindfulness application that provides brief lessons addressing topics such as stress, focus, gratitude, and well-being. Participants will complete approximately 5 minutes or longer of mindfulness practice at least 5 days per week for 4 weeks.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Participant Retention Rate at Week 4
大体时间：Baseline through Week 4
Percentage of enrolled participants who complete the 4-week intervention and post-intervention assessment. The feasibility benchmark is greater than 75%.
Baseline through Week 4
Percentage of Eligible Individuals Who Consent and Enroll
大体时间：From recruitment opening through enrollment of the final participant, up to 6 months.
Recruitment rate will equal the number of eligible individuals who consent and enroll divided by the total number determined eligible, multiplied by 100. The feasibility benchmark is greater than 70%.
From recruitment opening through enrollment of the final participant, up to 6 months.
Percentage of Recommended Practice Days Completed
大体时间：During the 4-week intervention
Adherence will be calculated from participant self-reports as completed practice days divided by 20 recommended practice days, multiplied by 100. The benchmark is greater than 75%.
During the 4-week intervention
Assessment Completion Rate
大体时间：Baseline and Week 4
Percentage of expected baseline and post-intervention questionnaires completed by enrolled participants. The benchmark is greater than 75%.
Baseline and Week 4
Participant Satisfaction With Assigned App
大体时间：Week 4
Satisfaction will be measured with the assigned-app satisfaction questionnaire. Items are rated from 1 to 5, with higher scores indicating greater satisfaction. Results will be summarized overall and by intervention arm.
Week 4
Assigned-App Usability Measured by the System Usability Scale
大体时间：Week 4
The 10-item System Usability Scale produces a total score from 0 to 100. Higher scores indicate better perceived usability.
Week 4

次要结果测量

结果测量
措施说明
大体时间
Change in Perceived Stress Scale-10 Score
大体时间：Baseline to Week 4
The PSS-10 contains 10 items and produces a total score from 0 to 40. Higher scores indicate greater perceived stress. Change from baseline will be reported overall and by arm.
Baseline to Week 4
Change in Index of Race-Related Stress-Brief Score
大体时间：Baseline to Week 4
The 22-item IRRS-B produces a total score from 0 to 88. Higher scores indicate greater race-related stress. Change from baseline will be reported overall and by arm.
Baseline to Week 4
Change in POMS-SF Depression Subscale Score
大体时间：Baseline to Week 4
The six-item depression subscale produces a score from 0 to 24. Higher scores indicate greater depressive mood disturbance.
Baseline to Week 4
Change in POMS-SF Tension/Anxiety Subscale Score
大体时间：Baseline to Week 4
The six-item tension/anxiety subscale produces a score from 0 to 24. Higher scores indicate greater tension or anxiety.
Baseline to Week 4
Change in Insomnia Severity Index Score
大体时间：Baseline to Week 4
The seven-item Insomnia Severity Index produces a total score from 0 to 28. Higher scores indicate more severe insomnia symptoms.
Baseline to Week 4

其他结果措施

结果测量
措施说明
大体时间
Participant-Reported Cultural Relevance and App Feedback
大体时间：Week 4 and, when applicable, within approximately 1 week after Week 4
Cultural relevance, perceived usefulness, barriers, benefits, and recommendations will be assessed through post-intervention items and brief open-ended feedback. Optional remote interviews may provide additional qualitative feedback.
Week 4 and, when applicable, within approximately 1 week after Week 4

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Arizona State University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月16日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年9月2日

首先提交符合 QC 标准的

2026年9月2日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月16日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00023706

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be made publicly available. Aggregate or de-identified summary findings may be disseminated through presentations, publications, or participant summaries. Any future sharing of de-identified participant data would require additional institutional review and must be consistent with the informed consent form and Arizona State University requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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