Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorThe University of Hong Kong

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any organic neurological or cardiac conditions

Prescription of cardiovascular medication

Active severe suicidal ideation

Diabetes as this can affect HRV

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Heart Rate Variability Biofeedback (HRV-B)Experimental treatment 1 intervention
Group B: Music ListeningActive comparator 1 intervention

Trial outcomes

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).

Time frame
5 weeks, 3 data points

Secondary outcomes

1

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).

Time frame
5 weeks, 6 data points
2

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).

Time frame
5 weeks, 2 data points
3

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.

Time frame
5 weeks, 70 data points
4

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).

Time frame
5 weeks, 2 data points.

Other outcomes

Sponsors and contacts

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