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Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II) (BEGIN II)

2026年9月2日 更新者：Balachundhar Subramaniam、Beth Israel Deaconess Medical Center

This study is testing whether a short, daily, app-based meditation can help young adults feel better in their everyday lives.

Adults aged 18-40 years who live in the United States and have not meditated regularly (defined as more than four times per week at any point in their lives) are invited to participate.

Participants will be randomly assigned to one of three groups for 4 weeks:

  1. Intervention group: Participants will complete a 7-minute Miracle of Mind meditation each day using a mobile app.
  2. Active comparator group: Participants will listen to a neutral 7-minute audio lesson each day.
  3. Control group: Participants will continue their usual daily routine without adding anything new.

All participants will complete brief online surveys at the start of the study and several times during the 4-week study period. Surveys will ask about mood, stress, anxiety, overall well-being, and mindfulness.

Participants who already wear a smartwatch, such as a Fitbit or Apple Watch, may choose to share heart rate and related data so that researchers can examine whether meditation may also affect physical signs of stress.

Investigators will compare changes over time among the three groups to determine whether the daily 7-minute meditation helps young adults feel better, experience less stress, and become more emotionally resilient.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

354

阶段

  • 不适用

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

是的

描述

Inclusion Criteria:

  • Individuals between the ages of 18-40 years
  • Currently residing in the USA
  • Individuals who are English speaking
  • Willing and able to download an application on iOS/Android

Exclusion Criteria:

  • Individuals who are non-English speaking
  • Unable to access an iOS/Android smartphone
  • Individuals who regularly practice any form of meditation >4 times per week
  • Individuals scoring 9-12 on the PHQ-4, or ≥3 on either the PHQ-2 or GAD-2 subscale

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：预防
  • 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：Intervention arm: Daily Miracle of Mind meditation
Participants in this group will use a study app to do a 7-minute Miracle of Mind guided meditation once a day for 4 weeks. The meditation is voice-guided, done while seated, and uses simple breathing techniques. No prior meditation experience is required.
行为的：Miracle of Mind meditation
Miracle of Mind is a 7-minute meditation that incorporates breath and awareness to enhance mental health and clarity. The practice involves voice-guided seated meditation with simple breathing techniques. This is a simple, safe intervention that does not require any previous meditation experience.
有源比较器：Active control arm: Daily neutral audio learning
Participants in this group will use the same study app to listen to a neutral 7-minute audio lesson once a day for 4 weeks. The lessons cover general educational topics and are designed not to be emotional, inspirational, or related to psychology.
行为的：Neutral audio learning task
Active control participants are asked to listen to an approximately 7-minute neutral audio learning task daily in the 3Cs app for the duration of the study. A total of 28 audio learning tasks were sourced from the SDG Academy and Harvard University YouTube and SoundCloud content were screened prior to inclusion.
无干预：Passive control arm: Usual routine
Participants in this group will not receive any new activity through the app and will continue their usual daily routine for 4 weeks. They will complete the same study surveys as the other groups but will not be asked to meditate or listen to audio lessons.

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
Well-being
大体时间："Baseline, Week 2 and Week 4"
To assess whether a 7-minute digital meditation practiced daily for 4 weeks improves mental well-being, as measured by the World Health Organization-Five Well-Being Index (WHO-5). The WHO-5 total raw score ranges from 0 to 25 where higher scores indicate better mental well-being.
"Baseline, Week 2 and Week 4"

次要结果测量

结果测量
措施说明
大体时间
Mindfulness
大体时间："Baseline and 4 weeks"
To assess whether the 7-minute digital meditation practiced daily for 4 weeks improves mindfulness, as measured by the Mindful Attention Awareness Scale (MAAS). The MAAS mean score ranges from 1 to 6; higher scores indicate greater dispositional mindfulness and attention to present-moment experiences.
"Baseline and 4 weeks"
Overall health
大体时间："Baseline, Week 2 and Week 4"
To assess whether the 7-minute digital meditation practiced daily for 4 weeks improves overall health, as measured by the Whole Person Health Index (WPHI). The WPHI is a 9-item self-reported measure where total scores range from 9 to 45. Higher scores indicate better overall self-reported whole-person health.
"Baseline, Week 2 and Week 4"
Stress
大体时间："Baseline, Week 1, Week 2, Week 3 and Week 4"
To assess whether the 7-minute digital meditation practiced daily for 4 weeks reduces psychological distress, as measured by the Schwartz Outcome Scale-10 (SOS-10). The SOS-10 total score ranges from 0 to 60. Higher scores indicate better psychological well-being and functioning, and lower levels of psychological distress.
"Baseline, Week 1, Week 2, Week 3 and Week 4"
Anxiety
大体时间："Baseline, Week 1, Week 2, Week 3 and Week 4"
To assess whether the 7-minute digital meditation practiced daily for 4 weeks reduces anxiety, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 8a. The PROMIS Anxiety Short Form 8a includes 8 items, each scored from 1 to 5. The summed raw score ranges from 8 to 40, with higher scores indicating greater anxiety symptoms and a worse outcome.
"Baseline, Week 1, Week 2, Week 3 and Week 4"
Positive and Negative Affect
大体时间："Baseline, Week 1, Week 2, Week 3 and Week 4"

To assess whether the 7-minute digital meditation practiced daily for 4 weeks improves emotional well-being, as measured by the Scale of Positive and Negative Experience (SPANE). The SPANE is a 12-item self-reported measure consisting of two 6-item subscales: Positive Experience (SPANE-P) and Negative Experience (SPANE-N).

The SPANE-P score ranges from 6 to 30, with higher scores indicating more frequent positive emotions. The SPANE-N score ranges from 6 to 30, with higher scores indicating more frequent negative emotions and a worse outcome.

The SPANE Balance score (SPANE-B) is calculated as SPANE-P minus SPANE-N and ranges from -24 to 24. Higher scores indicate a more favorable balance of positive relative to negative emotional experiences and a better outcome.
"Baseline, Week 1, Week 2, Week 3 and Week 4"

其他结果措施

结果测量
措施说明
大体时间
Heart Rate
大体时间：From enrollment to Week 4
To assess differences between study groups in trajectories of heart rate during the 4-week study period, using heart rate data collected from participants' compatible wearable devices. Heart rate will be expressed in beats per minute (bpm).
From enrollment to Week 4
Heart Rate Variability
大体时间：From enrollment to Week 4
To assess differences between study groups in trajectories of heart rate variability during the 4-week study period, using heart rate variability data collected from participants' compatible wearable devices. Heart rate variability will be reported using the pre-specified device-derived metric and units, such as milliseconds (ms). Higher values generally indicate greater beat-to-beat variability.
From enrollment to Week 4
Breathing Rate
大体时间：From enrollment to Week 4
To assess differences between study groups in trajectories of breathing rate during the 4-week study period, using respiratory-rate data collected from participants' compatible wearable devices. Breathing rate will be expressed in breaths per minute. Higher values indicate a higher breathing rate
From enrollment to Week 4
Step Counts
大体时间：From enrollment to Week 4
To assess differences between study groups in daily physical activity during the 4-week study period, using daily step-count data collected from participants' compatible wearable devices. Step count will be reported as the total number of steps per day. Values range from 0 upward, with higher values indicating more ambulatory physical activity.
From enrollment to Week 4
Sleep
大体时间：From enrollment to Week 4
To assess differences between study groups in sleep time, efficiency and average deep sleep duration during the 4-week study period, using sleep data collected from participants' compatible wearable devices.
From enrollment to 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

Beth Israel Deaconess Medical Center

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15日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年4月10日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月26日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年8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

  • 2026P000078

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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