Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis
Starting soon · Not applicable
Conditions studied: First Episode Psychosis (FEP)
In brief
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.
Key facts
- Study ID
- NCT07628699
- Run by
- The University of Hong Kong
- People needed
- 80
- Starts
- 2026-06-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Queen Mary Hospital/University of Hong Kong — Hong Kong, SAR China, Hong Kong
Full record on ClinicalTrials.gov
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