Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being
8 september 2026 bijgewerkt door: Massachusetts Institute of Technology
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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
29
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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Massachusetts
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Cambridge, Massachusetts, Verenigde Staten, 02142
- MIT Media Lab
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusion Criteria:
- High alexithymia score at screening (TAS-20 >= 50)
Exclusion Criteria:
- Severe psychiatric condition
- Any type of heart arrythmia
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
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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)
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Sham-vergelijker: 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.
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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)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Center for Epidemiological Studies-Depression Scale
Tijdsspanne: Difference from measurement at the start of each arm to end of each arm (1 week span)
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Measured by the standard scoring procedure in each lab visit at the start of the week.
Decrease is considered an improvement.
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Difference from measurement at the start of each arm to end of each arm (1 week span)
|
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Interoceptive accuracy
Tijdsspanne: 1 week (difference between SensHB at the start of each arm and the end of each arm)
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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)
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1 week (difference between SensHB at the start of each arm and the end of each arm)
|
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Snaith-Hamilton Pleasure Scale
Tijdsspanne: 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
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Difference from measurement at the start of each arm to end of each arm (1 week span)
|
|
General Anxiety Disorder-7 Anxiety Scale
Tijdsspanne: 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.
|
Difference from measurement at the start of each arm to end of each arm (1 week span)
|
|
Toronto Alexithymia Scale-20 Alexithymia Scale
Tijdsspanne: 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.
|
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
Tijdsspanne: 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.
|
Difference from measurement at the start of each arm to end of each arm (1 week span)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Interoceptive confidence
Tijdsspanne: 1 week (measure difference between start and end of each arm)
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Self rated confidence in the accuracy of heartbeat count
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1 week (measure difference between start and end of each arm)
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Interoceptive awareness
Tijdsspanne: Start of each arm to end of each arm (1 week)
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Multidimensional Assessment of Interoceptive Awareness -2 total score.
Increase indicates improved interoceptive awareness.
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Start of each arm to end of each arm (1 week)
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Daily mood
Tijdsspanne: 1 week (measured each day of the arm)
|
Brief Mood Introspection Scale (BMIS) positive-negative axis measured each day.
Increase indicates increased positive affect.
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1 week (measured each day of the arm)
|
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Daily mood variability
Tijdsspanne: 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.
|
1 week (measured each day of the arm)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Pattie Maes, PhD, Massachusetts Institute of Technology
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
26 juni 2025
Primaire voltooiing (Werkelijk)
19 september 2025
Studie voltooiing (Werkelijk)
19 september 2025
Studieregistratiedata
Eerst ingediend
23 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 september 2026
Eerst geplaatst (Werkelijk)
9 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 september 2026
Laatste update ingediend die voldeed aan QC-criteria
8 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2502001554
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Defidentified individual survey responses and sensHB accuracy data and analysis code
IPD-tijdsbestek voor delen
Available indefinitely beginning March 2026
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- SAP
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .