- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07809958
Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being
8. september 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
29
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Massachusetts
-
Cambridge, Massachusetts, Forente stater, 02142
- MIT Media Lab
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- High alexithymia score at screening (TAS-20 >= 50)
Exclusion Criteria:
- Severe psychiatric condition
- Any type of heart arrythmia
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
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-komparator: 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.
|
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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Center for Epidemiological Studies-Depression Scale
Tidsramme: 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)
|
|
Interoceptive accuracy
Tidsramme: 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)
|
1 week (difference between SensHB at the start of each arm and the end of each arm)
|
|
Snaith-Hamilton Pleasure Scale
Tidsramme: 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
|
Difference from measurement at the start of each arm to end of each arm (1 week span)
|
|
General Anxiety Disorder-7 Anxiety Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Interoceptive confidence
Tidsramme: 1 week (measure difference between start and end of each arm)
|
Self rated confidence in the accuracy of heartbeat count
|
1 week (measure difference between start and end of each arm)
|
|
Interoceptive awareness
Tidsramme: Start of each arm to end of each arm (1 week)
|
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
Tidsramme: 1 week (measured each day of the arm)
|
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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Pattie Maes, PhD, Massachusetts Institute of Technology
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. juni 2025
Primær fullføring (Faktiske)
19. september 2025
Studiet fullført (Faktiske)
19. september 2025
Datoer for studieregistrering
Først innsendt
23. juli 2026
Først innsendt som oppfylte QC-kriteriene
8. september 2026
Først lagt ut (Faktiske)
9. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2502001554
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Defidentified individual survey responses and sensHB accuracy data and analysis code
IPD-delingstidsramme
Available indefinitely beginning March 2026
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- SEVJE
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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