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NCT07628699
Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis
Conditions: First Episode Psychosis (FEP)
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: The University of Hong Kong
Location: Queen Mary Hospital/University of Hong Kong Hong Kong SAR China
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07628699). StuddyBuddy aggregates publicly available trial information.