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NCT Number: NCT07809958

Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being

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.

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Key information

Conditions

Interoceptive Awareness Affective Symptoms Alexithymia Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Disorders Interoception Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MIT Media Lab

Cambridge, Massachusetts, 02142, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Severe psychiatric condition
  • Any type of heart arrythmia

Treatment and study plan

Heart rate feedback from smartwatch

Device

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)

Primary outcomes

  1. Center for Epidemiological Studies-Depression Scale

    Time frame: 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.

  2. Interoceptive accuracy

    Time frame: 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)

  3. Snaith-Hamilton Pleasure Scale

    Time frame: 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

  4. General Anxiety Disorder-7 Anxiety Scale

    Time frame: 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.

  5. Toronto Alexithymia Scale-20 Alexithymia Scale

    Time frame: 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.

  6. General Health Questionnaire-12 General Mental Distress scale

    Time frame: 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.

Secondary outcomes

  1. Interoceptive confidence

    Time frame: 1 week (measure difference between start and end of each arm)

    Self rated confidence in the accuracy of heartbeat count

  2. Interoceptive awareness

    Time frame: Start of each arm to end of each arm (1 week)

    Multidimensional Assessment of Interoceptive Awareness -2 total score. Increase indicates improved interoceptive awareness.

  3. Daily mood

    Time frame: 1 week (measured each day of the arm)

    Brief Mood Introspection Scale (BMIS) positive-negative axis measured each day. Increase indicates increased positive affect.

  4. Daily mood variability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts Institute of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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