Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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