Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being

NCT07809958 | Completed

• 1 other identifier: 2502001554
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Interoceptive Awareness; Interoception; Alexithymia; Anxiety; Depression Disorders

Keywords

interoception; mental health; wearable; smartwatch; biofeedback

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Interoceptive confidence

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

• Interoceptive awareness

  Start of each arm to end of each arm (1 week)

• Daily mood

  1 week (measured each day of the arm)

• Daily mood variability

  1 week (measured each day of the arm)

Study Arms (2)

Real heartrate feedback

EXPERIMENTAL

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

Sham heartrate feedback

SHAM COMPARATOR

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

Interventions

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)

Real heartrate feedback; Sham heartrate feedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe psychiatric condition
• Any type of heart arrythmia

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead

Study Sites (1)

MIT Media Lab

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Affective Symptoms; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Pattie Maes, PhD

  Massachusetts Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: September 9, 2026
• Study Start: June 26, 2025
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Available indefinitely beginning March 2026
• 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

Locations

US (1)