- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07809958
Haptic Feedback for Improved Interoceptive Awareness and Mental Well-being
8 september 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
29
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Massachusetts
-
Cambridge, Massachusetts, Förenta staterna, 02142
- MIT Media Lab
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- High alexithymia score at screening (TAS-20 >= 50)
Exclusion Criteria:
- Severe psychiatric condition
- Any type of heart arrythmia
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 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.
|
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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Center for Epidemiological Studies-Depression Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Interoceptive confidence
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Pattie Maes, PhD, Massachusetts Institute of Technology
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 juni 2025
Primärt slutförande (Faktisk)
19 september 2025
Avslutad studie (Faktisk)
19 september 2025
Studieregistreringsdatum
Först inskickad
23 juli 2026
Först inskickad som uppfyllde QC-kriterierna
8 september 2026
Första postat (Faktisk)
9 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2502001554
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Defidentified individual survey responses and sensHB accuracy data and analysis code
Tidsram för IPD-delning
Available indefinitely beginning March 2026
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- SAV
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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