Psychometric Characterization of Patients With Cardiac Arrhythmias
- Conditions
- Cardiac ArrhythmiaPersonalityPsychological StressAnxietyDepression
- Registration Number
- NCT04474418
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Age of majority (min. 18 years old)
- no severe cognitive dysfunction
- diagnosed cardiac arrhythmias
- reason of admission is the treatment of cardiac arrhythmia
- medium to severe cognitive dysfunction
- doubt on capacity to give consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Beck Depression Inventory (BDI) - Change from Baseline at 6 months From Baseline at 6 months (Follow-up) after standard therapy BDI is a questionnaire measuring depression
- Secondary Outcome Measures
Name Time Method Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI) Baseline ASI is a Questionnaire measuring anxiety sensitivity
NEO-FFI personality inventory Only at baseline personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness
Electrocardiography (ECG) - Change from Baseline at 6 months From Baseline at 6 months (Follow-up) after standard therapy measuring heart activity and signs of cardiac arrhythmias
Angstkontrollfragebogen (AKF) - 6 months after standard therapy 6 months after standard therapy AKF is the German Version of the Anxiety Control Questionnaire
Resilienzskala (RS-13) - 3 months after standard therapy 3 months after standard therapy Questionnaire to measure resilience
Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy 6 months after standard therapy Questionnaire to measure self-efficacy
ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months From Baseline at 6 months after standard therapy Questionnaire to assess symptoms of psychiatric disorders
Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months From Baseline at 6 months after standard therapy Questionnaire to measure psychological stress perception
Euroquol EQ-5D-3L - Change from Baseline at 6 From Baseline at 6 months after standard therapy Questionnaire to measure quality of life
Heart beat Counting Task by Schandry Baseline Assessment of patients heart beat perception
Angstkontrollfragebogen (AKF) - Baseline Baseline before standard therapy AKF is the German Version of the Anxiety Control Questionnaire
Angstkontrollfragebogen (AKF) - 3 months after standard therapy 3 months after standard therapy AKF is the German Version of the Anxiety Control Questionnaire
Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months From Baseline at 6 months (Follow-up) after standard therapy BAI is a questionnaire measuring anxiety
Heart rate variability - Baseline Baseline before standard therapy heart rate variability is a non-invasive method to measure autonomic nervous system function
Resilienzskala (RS-13) - Baseline Baseline Questionnaire to measure resilience
Resilienzskala (RS-13) - 6 months after standard therapy 6 months after standard therapy Questionnaire to measure resilience
Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline Baseline Questionnaire to measure self-efficacy
Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI) 3 months after standard therapy ASI is a Questionnaire measuring anxiety sensitivity
Heart rate variability - 3 months after standard therapy 3 months after standard therapy heart rate variability is a non-invasive method to measure autonomic nervous system function
Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy 3 months after standard therapy Questionnaire to measure self-efficacy
Anxiety Sensitivity Index (ASI) - 6 months after standard therapy Anxiety Sensitivity Index (ASI) 6 months after standard therapy ASI is a Questionnaire measuring anxiety sensitivity
Heart rate variability - 6 months after standard therapy 6 months after Standardtherapie heart rate variability is a non-invasive method to measure autonomic nervous system function
Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months From Baseline at 6 months after standard therapy Questionnaire to measure body sensations related to anxiety
Herzangstfragebogen (HAF-17) - Change from Baseline at 6 From Baseline at 6 months after standard therapy Questionnaire to measure anxiety with respect to cardiac symptoms
Fragebogen zu Akzeptanz und Handeln II (FAH-II) - Change from Baseline at 6 months From Baseline at 6 months after standard therapy Questionnaire to measure psychological flexibility
Unsicherheitsintoleranzfragebogen (UI-18) Baseline Questionnaire to measure tolerance to uncertainty
Trial Locations
- Locations (1)
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany