Be-PART: Berlin Psychometric Characterization of Patients With Cardiac ARrhyThmias
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory (BDI) - Change from Baseline at 6 months
研究概览
简要总结
To investigate the influence of different psychological parameters (e.g. depression, anxiety, personality traits, resilience, tolerance of uncertainty or heart beat perception) on treatment outcome and quality of life in patients with cardiac arrythmias.
详细描述
This longitudinal observational study examines patients with cardiac arrhythmia (such as atrial fibrillation or atrial flutter) who are undergoing a conventional standard therapy in the Department of Cardiology of the Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin. To examine the impact of psychological symptoms such as anxiety, depression, resilience and risk factors (e.g. neuroticism) on cardiac treatment outcomes, patients are evaluated with a standardized psychological assessment including established questionnaires. The baseline observation is performed before the standard treatment of the arrhythmia (e.g. pharmacological treatment or electrophysiological methods). Follow-up observations are made 3 and 6 month after the cardiological intervention.
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
- •Age of majority (min. 18 years old)
- •no severe cognitive dysfunction
- •diagnosed cardiac arrhythmias
- •reason of admission is the treatment of cardiac arrhythmia
排除标准
- •medium to severe cognitive dysfunction
- •doubt on capacity to give consent
结局指标
主要结局
Beck Depression Inventory (BDI) - Change from Baseline at 6 months
时间窗: From Baseline at 6 months (Follow-up) after standard therapy
BDI is a questionnaire measuring depression
次要结局
- Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI)(Baseline)
- NEO-FFI personality inventory(Only at baseline)
- Electrocardiography (ECG) - Change from Baseline at 6 months(From Baseline at 6 months (Follow-up) after standard therapy)
- Angstkontrollfragebogen (AKF) - 6 months after standard therapy(6 months after standard therapy)
- Resilienzskala (RS-13) - 3 months after standard therapy(3 months after standard therapy)
- Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy(6 months after standard therapy)
- ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months(From Baseline at 6 months after standard therapy)
- Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months(From Baseline at 6 months after standard therapy)
- Euroquol EQ-5D-3L - Change from Baseline at 6(From Baseline at 6 months after standard therapy)
- Heart beat Counting Task by Schandry(Baseline)
- Angstkontrollfragebogen (AKF) - Baseline(Baseline before standard therapy)
- Angstkontrollfragebogen (AKF) - 3 months after standard therapy(3 months after standard therapy)
- Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months(From Baseline at 6 months (Follow-up) after standard therapy)
- Heart rate variability - Baseline(Baseline before standard therapy)
- Resilienzskala (RS-13) - Baseline(Baseline)
- Resilienzskala (RS-13) - 6 months after standard therapy(6 months after standard therapy)
- Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline(Baseline)
- Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI)(3 months after standard therapy)
- Herzangstfragebogen (HAF-17) - Change from Baseline at 6(From Baseline at 6 months after standard therapy)
- Heart rate variability - 3 months after standard therapy(3 months after standard therapy)
- Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy(3 months after standard therapy)
- Anxiety Sensitivity Index (ASI) - 6 months after standard therapy Anxiety Sensitivity Index (ASI)(6 months after standard therapy)
- Heart rate variability - 6 months after standard therapy(6 months after Standardtherapie)
- Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months(From Baseline at 6 months after standard therapy)
- Fragebogen zu Akzeptanz und Handeln II (FAH-II) - Change from Baseline at 6 months(From Baseline at 6 months after standard therapy)
- Unsicherheitsintoleranzfragebogen (UI-18)(Baseline)
研究者
Dr. Jens Plag
MD
Charite University, Berlin, Germany