[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641033":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":38,"responsibleParty":50,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":25,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":25,"overallStatus":71,"whyStopped":25,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Heart Rate Variability Biofeedback (HRV-B)","EXPERIMENTAL","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.",[13],"Behavioral: Heart Rate Variability Biofeedback",{"label":15,"type":16,"description":17,"interventionNames":18},"Music Listening","ACTIVE_COMPARATOR","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.",[19],"Behavioral: Music Listening",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Heart Rate Variability Biofeedback",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Sherry Kit Wa Chan, PhD","CONTACT","+(852) 2255 3064","kwsherry@hku.hk",{"name":35,"role":31,"phone":36,"phoneExt":25,"email":37},"Sophia M Vann-Adibe, Bachelors of Science","+85253249444","svann@hku.hk",[39],{"facility":40,"status":25,"city":41,"state":42,"zip":25,"country":41,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"Queen Mary Hospital\u002FUniversity of Hong Kong","Hong Kong","SAR China","HK",{"type":45,"coordinates":46},"Point",[47,48],114.17469,22.27832,{"lat":48,"lon":47},{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100641033","digital-heart-rate-variability-biofeedback-intervention-for-first-episode-psychosis-100641033",false,"NCT07628699","Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis","Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with first-episode-psychosis who have been in treatment for less than 5 years\n* Inclusive of affective and non-affective psychosis\n* Aged 18-55\n* 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\n* Able to provide written informed consent.\n* Patients should be stable but with symptoms present\n* Score a minimum of 7 on the Calgary Depression Scale.\n\nExclusion Criteria:\n\n* Any organic neurological or cardiac conditions\n* Prescription of cardiovascular medication\n* Active severe suicidal ideation\n* Diabetes as this can affect HRV\n* Current substance abuse\n* An ECG will be performed on each participant prior to joining the study to exclude undiagnosed cardiac conditions","ALL","18 Years","55 Years",{"count":63,"type":64},80,"ESTIMATED","INTERVENTIONAL",[67],"NA","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.",[70],"First Episode Psychosis (FEP)","NOT_YET_RECRUITING","2026-06-02",{"date":74,"type":75},"2026-06-05","ACTUAL",{"date":77,"type":64},"2026-06-01",{"date":79,"type":64},"2026-08",{"name":5,"class":6},1]