Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis: A Randomized Controlled Trial
| Registry | NCT07628699 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | The University of Hong Kong (Other) |
| Conditions | First Episode Psychosis (FEP) |
| Interventions | Heart Rate Variability Biofeedback, Music Listening (Behavioral) |
| Dates | start 2026-06-01 (estimated), primary completion 2026-08-01 (estimated), completion 2026-08-01 (estimated), first posted 2026-06-05, last updated 2026-06-05 |
| Locations | 1 site in Hong Kong |
Related Papers Related Patents Related Grants Related Experts
All trials for First Episode Psychosis (FEP) All trials of Heart Rate Variability Biofeedback All trials of Music Listening
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Heart Rate Variability Biofeedback (HRV-B) | Experimental | 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. |
| Music Listening | Active comparator | 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. |
Sex: All, ages: 18 Years to 55 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Queen Mary Hospital/University of Hong Kong | Hong Kong, SAR China | Hong Kong |