Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis
2. juni 2026 oppdatert av: The University of Hong Kong
Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis: A Randomized Controlled Trial
The objective of the current study is to assess the impact of a five-week digital heart rate variability biofeedback (HRV-B) intervention or music listening on the well-being of first episode psychosis patients.
Heart rate variability (HRV) is a measure of how an individual's heart rate can adapt to a changing environment and mental and physiological challenges.
It has been well established that HRV can be regulated through actions such as slow breathing and meditation.
HRV Biofeedback (HRV-B) involves breathing at a specific frequency, usually around 6 breaths per minute, which has been shown to maximize HRV.
Research has shown that HRV-B interventions improved mental health symptoms in various populations including individuals at clinical high risk for psychosis.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sherry Kit Wa Chan, PhD
- Telefonnummer: +(852) 2255 3064
- E-post: kwsherry@hku.hk
Studer Kontakt Backup
- Navn: Sophia M Vann-Adibe, Bachelors of Science
- Telefonnummer: +85253249444
- E-post: svann@hku.hk
Studiesteder
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SAR China
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Hong Kong, SAR China, Hong Kong
- Queen Mary Hospital/University of Hong Kong
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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
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patients with first-episode-psychosis who have been in treatment for less than 5 years
- Inclusive of affective and non-affective psychosis
- Aged 18-55
- A diagnosis of schizophrenia-spectrum disorders or affective psychosis including schizoaffective disorder, bipolar affective disorders and depression with psychosis based on DSM V diagnostic criteria
- Able to provide written informed consent.
- Patients should be stable but with symptoms present
- Score a minimum of 7 on the Calgary Depression Scale.
Exclusion Criteria:
- Any organic neurological or cardiac conditions
- Prescription of cardiovascular medication
- Active severe suicidal ideation
- Diabetes as this can affect HRV
- Current substance abuse
- An ECG will be performed on each participant prior to joining the study to exclude undiagnosed cardiac conditions
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Heart Rate Variability Biofeedback (HRV-B)
The HRV-B intervention will consist of five weeks of daily HRV-B practice, based on previous empirical studies that used 5 weeks (Tatschl et al, 2020) with 6 weekly lab visits or checkins.
Participants will practice for 10 minutes in the morning and evening for a total of 20 minutes per day, using a wearable device and mobile app.
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The HRV-B intervention will consist of five weeks of daily HRV-B practice, based on previous empirical studies that used 5 weeks (Tatschl et al, 2020) with 6 weekly lab visits or checkins.
Participants will practice for 10 minutes in the morning and evening for a total of 20 minutes per day, using a wearable device and mobile app.
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Aktiv komparator: Music Listening
The control group will undergo a 5 week active control intervention consisting of daily music listening and 6 weekly check ins.
Control participants will listen to music through an app for 10 minutes in the morning and 10 minutes in the evening, for a total of 20 minutes daily, using a mobile app.
They will be instructed to avoid doing other tasks when listening to the music to ensure consistency between individuals.
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The control group will undergo a 5 week active control intervention consisting of daily music listening and 6 weekly check ins.
Control participants will listen to music through an app for 10 minutes in the morning and 10 minutes in the evening, for a total of 20 minutes daily, using a mobile app.
They will be instructed to avoid doing other tasks when listening to the music to ensure consistency between individuals.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Depression Symptoms
Tidsramme: 5 weeks, 3 data points
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The Chinese version of the Calgary Depression Scale (CDSS) will be administered to participants by a trained assessor biweekly at check-ins to assess depressive symptoms.
Minimum score: 0 (no depression) maximum score 27 (severe depression).
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5 weeks, 3 data points
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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State Paranoia
Tidsramme: 5 weeks, 6 data points
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The Chinese version of the Paranoid Ideation Checklist (Chan et al, 2011) will be completed by participants weekly during lab visits.
Minimum score: 18 (no state paranoia), maximum score 90 (severe state paranoia).
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5 weeks, 6 data points
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Psychotic Symptoms
Tidsramme: 5 weeks, 2 data points
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The Chinese version of the Positive and Negative Symptom Scale (PANSS) evaluation will be conducted by a trained assessor during intake and at the final visit to rate the severity of the patient's psychotic symptoms.
Minimum score: 30 (minimal psychotic symptoms) maximum score: 210 (severe psychotic symptoms).
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5 weeks, 2 data points
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Heart Rate Variability (HRV)
Tidsramme: 5 weeks, 70 data points
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RR Intervals (time between heart beats) are automatically stored in the Elite HRV app after every training session.
Additionally, SDNN and RMSSD as measured in the EliteHRV app will be extracted from each training session during the weekly checkins.
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5 weeks, 70 data points
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Ideas of Reference
Tidsramme: 5 weeks, 2 data points.
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The Chinese version of the Ideas of Reference Interview Scale (IRIS) will be administered to participants by a trained assessor on the initial and final lab visits.
Minimum score: 0 (no ideas of reference), maximum score 15 (endorsement of all 15 themes).
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5 weeks, 2 data points.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Chan, R. C. K., Li, X., Lai, M.-k., Li, H., Wang, Y., Cui, J., Deng, Y., & Raine, A. (2011). Paranoid Ideation Checklist [Database record]. APA PsycTests. https://doi.org/10.1037/t29207-000
- Tatschl JM, Hochfellner SM, Schwerdtfeger AR. Implementing Mobile HRV Biofeedback as Adjunctive Therapy During Inpatient Psychiatric Rehabilitation Facilitates Recovery of Depressive Symptoms and Enhances Autonomic Functioning Short-Term: A 1-Year Pre-Post-intervention Follow-Up Pilot Study. Front Neurosci. 2020 Jul 21;14:738. doi: 10.3389/fnins.2020.00738. eCollection 2020.
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 (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. august 2026
Studiet fullført (Antatt)
1. august 2026
Datoer for studieregistrering
Først innsendt
14. mai 2026
Først innsendt som oppfylte QC-kriteriene
2. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IRB UW 26-043
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
To protect the privacy of our patients we will not share IPD.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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