Psychometric Characterization of Patients With Cardiac Arrhythmias

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Be-PART: Berlin Psychometric Characterization of Patients With Cardiac ARrhyThmias

Conditions
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Cardiac Arrhythmia, Anxiety, Personality, Psychological Stress, Depression

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of majority (min. 18 years old) no severe cognitive dysfunction diagnosed cardiac arrhythmias reason of admission is the treatment of cardiac arrhythmia Exclusion Criteria: medium to severe cognitive dysfunction doubt on capacity to give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory (BDI) - Change from Baseline at 6 months | BDI is a questionnaire measuring depression | From Baseline at 6 months (Follow-up) after standard therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEO-FFI personality inventory | personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness | Only at baseline | 
| Electrocardiography (ECG) - Change from Baseline at 6 months | measuring heart activity and signs of cardiac arrhythmias | From Baseline at 6 months (Follow-up) after standard therapy | 
| Heart beat Counting Task by Schandry | Assessment of patients heart beat perception | Baseline | 
| Angstkontrollfragebogen (AKF) - Baseline | AKF is the German Version of the Anxiety Control Questionnaire | Baseline before standard therapy | 
| Angstkontrollfragebogen (AKF) - 3 months after standard therapy | AKF is the German Version of the Anxiety Control Questionnaire | 3 months after standard therapy | 
| Angstkontrollfragebogen (AKF) - 6 months after standard therapy | AKF is the German Version of the Anxiety Control Questionnaire | 6 months after standard therapy | 
| Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI) | ASI is a Questionnaire measuring anxiety sensitivity | Baseline | 
| Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI) | ASI is a Questionnaire measuring anxiety sensitivity | 3 months after standard therapy | 
| Anxiety Sensitivity Index (ASI) - 6 months after standard therapy Anxiety Sensitivity Index (ASI) | ASI is a Questionnaire measuring anxiety sensitivity | 6 months after standard therapy | 
| Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months | BAI is a questionnaire measuring anxiety | From Baseline at 6 months (Follow-up) after standard therapy | 
| Heart rate variability - Baseline | heart rate variability is a non-invasive method to measure autonomic nervous system function | Baseline before standard therapy | 
| Heart rate variability - 3 months after standard therapy | heart rate variability is a non-invasive method to measure autonomic nervous system function | 3 months after standard therapy | 
| Heart rate variability - 6 months after standard therapy | heart rate variability is a non-invasive method to measure autonomic nervous system function | 6 months after Standardtherapie | 
| Resilienzskala (RS-13) - Baseline | Questionnaire to measure resilience | Baseline | 
| Resilienzskala (RS-13) - 3 months after standard therapy | Questionnaire to measure resilience | 3 months after standard therapy | 
| Resilienzskala (RS-13) - 6 months after standard therapy | Questionnaire to measure resilience | 6 months after standard therapy | 
| Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline | Questionnaire to measure self-efficacy | Baseline | 
| Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy | Questionnaire to measure self-efficacy | 3 months after standard therapy | 
| Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy | Questionnaire to measure self-efficacy | 6 months after standard therapy | 
| ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months | Questionnaire to assess symptoms of psychiatric disorders | From Baseline at 6 months after standard therapy | 
| Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months | Questionnaire to measure psychological stress perception | From Baseline at 6 months after standard therapy | 
| Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months | Questionnaire to measure body sensations related to anxiety | From Baseline at 6 months after standard therapy | 
| Herzangstfragebogen (HAF-17) - Change from Baseline at 6 | Questionnaire to measure anxiety with respect to cardiac symptoms | From Baseline at 6 months after standard therapy | 
| Fragebogen zu Akzeptanz und Handeln II (FAH-II) - Change from Baseline at 6 months | Questionnaire to measure psychological flexibility | From Baseline at 6 months after standard therapy | 
| Euroquol EQ-5D-3L - Change from Baseline at 6 | Questionnaire to measure quality of life | From Baseline at 6 months after standard therapy | 
| Unsicherheitsintoleranzfragebogen (UI-18) | Questionnaire to measure tolerance to uncertainty | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrhythmia, personality, psychological symptoms