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Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being

2026年9月8日 更新者:Massachusetts Institute of Technology

Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being: A Comprehensive In-the-Wild Study for Wellness

This study investigates the relationship between heart-beat haptic feedback on interoceptive awareness and mental-wellbeing. Previous research showed non-significant results in short-term emotion regulation tasks when given heartbeat haptic feedback, suggesting the need for an extended adjustment training period to build trust with interoceptive feedback systems. To address this, the experimenters propose an in-the-wild study where participants wear a Bangle.js smartwatch for one week each under two conditions: (1) Real heartbeat feedback and (2) Off-set heartbeat feedback. This design aims to examine the influence of haptic feedback on psychological characteristics, including alexithymia, anhedonia, depression, anxiety, and general mental health. The experimenters will also explore the usability and comfort levels related to prolonged wearable use, as well as the participants' ability to distinguish between real and off-set heartbeat feedback, particularly across different levels of alexithymia traits.

研究概览

研究类型

介入性

注册 (实际的)

29

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。

学习地点

    • Massachusetts
      • Cambridge、Massachusetts、美国、02142
        • MIT Media Lab

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
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • High alexithymia score at screening (TAS-20 >= 50)

Exclusion Criteria:

  • Severe psychiatric condition
  • Any type of heart arrythmia

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:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Real heartrate feedback
Participants wear a smartwatch during all waking hours which delivers vibration pulses at a frequency matching the current heart rate sensed by the smartwatch
Participants wear a smartwatch during their waking hours which delivers pulses of vibration which can be matched to the frequency of the current heart rate (real condition) or heart rate from one hour ago (sham condition)
假比较器:Sham heartrate feedback
Participants wear a smartwatch during all waking hours which delivers vibration pulses at a frequency matching the heart rate from one hour ago as measured by the smartwatch. The time delay means that feedback does not match the current heartrate but maintains the overall descriptive statistics of the participant's heartbeat.
Participants wear a smartwatch during their waking hours which delivers pulses of vibration which can be matched to the frequency of the current heart rate (real condition) or heart rate from one hour ago (sham condition)

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
Center for Epidemiological Studies-Depression Scale
大体时间:Difference from measurement at the start of each arm to end of each arm (1 week span)
Measured by the standard scoring procedure in each lab visit at the start of the week. Decrease is considered an improvement.
Difference from measurement at the start of each arm to end of each arm (1 week span)
Interoceptive accuracy
大体时间:1 week (difference between SensHB at the start of each arm and the end of each arm)
Interoceptive accuracy measured using SensHb (slope of the correlation of estimated heart rate with smartwatch-recorded heart rate measured over three 1-minute measurement periods during the in-lab questionnaire)
1 week (difference between SensHB at the start of each arm and the end of each arm)
Snaith-Hamilton Pleasure Scale
大体时间:Difference from measurement at the start of each arm to end of each arm (1 week span)
Measured at the lab visit at the start of each week. We sum the pleasure rating for each item so the score represents overall hedonic capacity (opposite of anhedonia). Increase is considered improvement
Difference from measurement at the start of each arm to end of each arm (1 week span)
General Anxiety Disorder-7 Anxiety Scale
大体时间:Difference from measurement at the start of each arm to end of each arm (1 week span)
Measured by the standard scoring procedure in each lab visit at the start of the week. Decrease is considered an improvement.
Difference from measurement at the start of each arm to end of each arm (1 week span)
Toronto Alexithymia Scale-20 Alexithymia Scale
大体时间:Difference from measurement at the start of each arm to end of each arm (1 week span)
Measured by the standard scoring procedure in each lab visit at the start of the week. Decrease is considered an improvement.
Difference from measurement at the start of each arm to end of each arm (1 week span)
General Health Questionnaire-12 General Mental Distress scale
大体时间:Difference from measurement at the start of each arm to end of each arm (1 week span)
Measured by the standard scoring procedure in each lab visit at the start of the week. Decrease is considered an improvement.
Difference from measurement at the start of each arm to end of each arm (1 week span)

次要结果测量

结果测量
措施说明
大体时间
Interoceptive confidence
大体时间:1 week (measure difference between start and end of each arm)
Self rated confidence in the accuracy of heartbeat count
1 week (measure difference between start and end of each arm)
Interoceptive awareness
大体时间:Start of each arm to end of each arm (1 week)
Multidimensional Assessment of Interoceptive Awareness -2 total score. Increase indicates improved interoceptive awareness.
Start of each arm to end of each arm (1 week)
Daily mood
大体时间:1 week (measured each day of the arm)
Brief Mood Introspection Scale (BMIS) positive-negative axis measured each day. Increase indicates increased positive affect.
1 week (measured each day of the arm)
Daily mood variability
大体时间:1 week (measured each day of the arm)
Standard deviation of the Brief Mood Introspection Scale (BMIS) positive-negative mood axis across all the days in an arm. Increase indicates increased emotional variability.
1 week (measured each day of the arm)

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。

调查人员

  • 首席研究员:Pattie Maes, PhD、Massachusetts Institute of Technology

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 (实际的)

2025年6月26日

初级完成 (实际的)

2025年9月19日

研究完成 (实际的)

2025年9月19日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年9月8日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Defidentified individual survey responses and sensHB accuracy data and analysis code

IPD 共享时间框架

Available indefinitely beginning March 2026

IPD 共享访问标准

Data are available to the general public. Data and analysis scripts can be found at https://osf.io/wfexj/overview and the preregistered analysis plan can be found at https://aspredicted.org/hnyw-cw85.pdf

IPD 共享支持信息类型

  • 树液
  • 分析代码

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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