Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis

NCT07628699 | Not Yet Recruiting

• 1 other identifier: IRB UW 26-043
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

First Episode Psychosis (FEP)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• State Paranoia

  5 weeks, 6 data points

• Psychotic Symptoms

  5 weeks, 2 data points

• Heart Rate Variability (HRV)

  5 weeks, 70 data points

• Ideas of Reference

  5 weeks, 2 data points.

Study Arms (2)

Heart Rate Variability Biofeedback (HRV-B)

EXPERIMENTAL

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

Music Listening

ACTIVE COMPARATOR

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

Interventions

Heart Rate Variability Biofeedback BEHAVIORAL

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.

Heart Rate Variability Biofeedback (HRV-B)

Music Listening BEHAVIORAL

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.

Music Listening

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital/University of Hong Kong

Hong Kong, SAR China, Hong Kong

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 32792897 BACKGROUND

Central Study Contacts

Sherry Kit Wa Chan, PhD

CONTACT

+(852) 2255 3064; kwsherry@hku.hk

Sophia M Vann-Adibe, Bachelors of Science

CONTACT

+85253249444; svann@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)