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Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07809958
Enrollment
29
Registered
2026-09-09
Start date
2025-06-26
Completion date
2025-09-19
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alexithymia, Anxiety, Depression Disorders, Interoception, Interoceptive Awareness

Keywords

interoception, mental health, wearable, smartwatch, biofeedback

Brief summary

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.

Interventions

DEVICEHeart rate feedback from 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)

Sponsors

Massachusetts Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Severe psychiatric condition * Any type of heart arrythmia

Design outcomes

Primary

MeasureTime frameDescription
Center for Epidemiological Studies-Depression ScaleDifference 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.
Interoceptive accuracy1 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)
Snaith-Hamilton Pleasure ScaleDifference 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
General Anxiety Disorder-7 Anxiety ScaleDifference 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.
Toronto Alexithymia Scale-20 Alexithymia ScaleDifference 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.
General Health Questionnaire-12 General Mental Distress scaleDifference 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.

Secondary

MeasureTime frameDescription
Interoceptive confidence1 week (measure difference between start and end of each arm)Self rated confidence in the accuracy of heartbeat count
Interoceptive awarenessStart of each arm to end of each arm (1 week)Multidimensional Assessment of Interoceptive Awareness -2 total score. Increase indicates improved interoceptive awareness.
Daily mood1 week (measured each day of the arm)Brief Mood Introspection Scale (BMIS) positive-negative axis measured each day. Increase indicates increased positive affect.
Daily mood variability1 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPattie Maes, PhD

Massachusetts Institute of Technology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026