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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Alexithymia; Interoception; Depression Disorders; Interoceptive Awareness
• Intervention / Treatment: Device: Heart rate feedback from smartwatch

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • MIT Media Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Severe psychiatric condition
• Any type of heart arrythmia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Heart 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)
Sham Comparator: 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.	Device: Heart 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center for Epidemiological Studies-Depression Scale	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	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	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	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	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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interoceptive confidence	Self rated confidence in the accuracy of heartbeat count	1 week (measure difference between start and end of each arm)
Interoceptive awareness	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	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	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)

Collaborators and Investigators

• Sponsor: Massachusetts Institute of Technology
• Investigators: Principal Investigator: Pattie Maes, PhD, Massachusetts Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Actual): September 19, 2025
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: biofeedback; mental health; wearable; smartwatch; interoception
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Anxiety Disorders; Affective Symptoms; Psychological Well-Being
• Other Study ID Numbers: 2502001554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Defidentified individual survey responses and sensHB accuracy data and analysis code
• IPD Sharing Time Frame: Available indefinitely beginning March 2026
• IPD Sharing Access Criteria: 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 Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No