Interoceptive AwarenessNCT07809958
Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being
A study testing Heart rate feedback from smartwatch in people with Interoceptive Awareness and Interoception, run by Massachusetts Institute of Technology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interoceptive Awareness, Interoception, Alexithymia
- What is being tested?
- Heart rate feedback from smartwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2025to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High alexithymia score at screening (TAS-20 >= 50)
Who cannot join
- Severe psychiatric condition
- Any type of heart arrythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Heart rate feedback from smartwatch
- Keywords
- interoception, mental health, wearable, smartwatch, biofeedback
- Medical subject headings
- Affective Symptoms, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate feedback from smartwatchDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Heart rate feedback from smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Difference from measurement at the start of each arm to end of each arm (1 week span)
Secondary outcomes (4)
Interoceptive confidence
Self rated confidence in the accuracy of heartbeat count
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week (measured each day of the arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start26 Jun 2025
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interoceptive AwarenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pattie Maes, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809958
- Sponsor's protocol ID
- 2502001554
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Defidentified individual survey responses and sensHB accuracy data and analysis code
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being: A Comprehensive In-the-Wild Study for Wellness
- ClinicalTrials.gov ID
- NCT07809958
- Acronym / sponsor ID
- 2502001554
- Keywords
- interoception, mental health, wearable, smartwatch, biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real heartrate feedback | Experimental | Device: Heart rate feedback from smartwatchParticipants wear a smartwatch during all waking hours which delivers vibration pulses at a frequency matching the current heart rate sensed by the smartwatch |
| Sham heartrate feedback | Sham comparator | Device: Heart rate feedback from smartwatchParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- High alexithymia score at screening (TAS-20 >= 50)
Key exclusion criteria (2 listed)
- Severe psychiatric condition
- Any type of heart arrythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate feedback from smartwatchParticipants 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) | Device | Real heartrate feedback, Sham heartrate feedback |
Primary outcome
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.
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)
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
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.
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.
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.
4 secondary outcomes
Interoceptive confidence
Time frame: 1 week (measure difference between start and end of each arm)
Interoceptive awareness
Time frame: Start of each arm to end of each arm (1 week)
Daily mood
Time frame: 1 week (measured each day of the arm)
Daily mood variability
Time frame: 1 week (measured each day of the arm)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. Defidentified individual survey responses and sensHB accuracy data and analysis code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pattie Maes, PhD principal investigator
Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate feedback from smartwatch in people with Interoceptive Awareness and Interoception, run by Massachusetts Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.