Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Heart Rate Variability Biofeedback, Music Listening.
- Who it may be relevant to
- Registry conditions: First Episode Psychosis (FEP). Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis: A Randomized Controlled Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Depression Symptoms [Time frame: 5 weeks, 3 data points]
Secondary outcome measures (4)
- State Paranoia [Time frame: 5 weeks, 6 data points]
- Psychotic Symptoms [Time frame: 5 weeks, 2 data points]
- Heart Rate Variability (HRV) [Time frame: 5 weeks, 70 data points]
- Ideas of Reference [Time frame: 5 weeks, 2 data points.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Queen Mary Hospital/University of Hong Kong — Hong Kong
Publications
- 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
- 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
Identifiers
NCT: NCT07628699 · IRB UW 26-043