Study of Heart Rate Variability as a Clinical Marker in a Population of Anxio-depressive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Beck depression inventory (BDI)
研究概览
简要总结
The heart rate (HR) is regulated by the autonomic nervous system (ANS) and results from a balance between the sympathetic nervous system (SNS) that accelerates the heart rate and the parasympathetic nervous system that slows the HR via the vagus nerve.
Low HRV is linked to poor emotional and cognitive regulation. Values for HRV are generally lower in depressed patients.
The aim of this study is to determine how HRV could be a clinical marker that can be used in routine psychiatry practice in patients with anxio-depressive disorders, to determine the severity of symptoms and the degree of response to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of the CHU Brugmann Hospital with an anxious or depressive disorder
排除标准
- 未提供
结局指标
主要结局
Beck depression inventory (BDI)
时间窗: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
Multiple choice (4 choices) questionnaire with 21 items. The end score can vary between 0 and 63. Score interpretation: 1-10: These ups and downs are considered normal. 11-16 Mild mood disturbance. 17-20 Borderline clinical depression. 21-30 Moderate depression. 31-40 : Severe depression. Over 40 :Extreme depression.
State trait Anxiety inventory (STAI)
时间窗: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Maslach Burnout inventory (MBI)
时间窗: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
The Maslach Burnout Inventory (MBI) is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout. All MBI items are scored using a 7 level frequency scale from "never" to "daily." Initial development had 3 components: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Scales should not be combined to form a single burnout scale.
Root mean square of successive differences (RMSSD)
时间窗: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
The Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR intervals. It reflects the activity of the parasympathetic nervous system.
High frequency percentage in the spectral analysis of the heart RR interval
时间窗: Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline
Spectral analysis of the RR interval is an indirect, noninvasive measurement tool of heart rate variability. High-frequency RR signals (0.15 to 0.4 Hz) reflect a parasympathetic activity and thus an influence of the vagal nerve on the heart. A high frequency heart variability is associated with a better perception of emotions and with pro-social behaviors.
次要结局
- Toronto Alexithymia scale (TAS 20)(Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline)
- Difficulties in Emotion Regulation Scale (DERS-18)(Measured only once at one visit taking place minimum 3 months and maximum 6 months after baseline)
研究者
Tatiana Besse-Hammer
Head of clinical research unit
Brugmann University Hospital