Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: First Episode Psychosis (FEP)
• Intervention / Treatment: Behavioral: Heart Rate Variability Biofeedback; Behavioral: Music Listening

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherry Kit Wa Chan, PhD; Phone Number: +(852) 2255 3064; Email: kwsherry@hku.hk
• Study Contact Backup: Name: Sophia M Vann-Adibe, Bachelors of Science; Phone Number: +85253249444; Email: svann@hku.hk

Study Locations

• Hong Kong
  • SAR China
    • Hong Kong, SAR China, Hong Kong
      • Queen Mary Hospital/University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Heart Rate Variability Biofeedback; 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Symptoms	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).	5 weeks, 3 data points

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Paranoia	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).	5 weeks, 6 data points
Psychotic Symptoms	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).	5 weeks, 2 data points
Heart Rate Variability (HRV)	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.	5 weeks, 70 data points
Ideas of Reference	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).	5 weeks, 2 data points.

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB UW 26-043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect the privacy of our patients we will not share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No