Anxiety, Cardiac Arrhythmia, Depression, Personality, Psychological Stress
Conditions
Keywords
cardiac arrhythmia, personality, psychological symptoms
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.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Angstkontrollfragebogen (AKF) - 6 months after standard therapy | 6 months after standard therapy | AKF is the German Version of the Anxiety Control Questionnaire |
| Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI) | Baseline | ASI is a Questionnaire measuring anxiety sensitivity |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NEO-FFI personality inventory | Only at baseline | personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness |
| Resilienzskala (RS-13) - 3 months after standard therapy | 3 months after standard therapy | 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 |
| Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy | 3 months after standard therapy | Questionnaire to measure self-efficacy |
| 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 |
| 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 |
| Euroquol EQ-5D-3L - Change from Baseline at 6 | From Baseline at 6 months after standard therapy | Questionnaire to measure quality of life |
| Unsicherheitsintoleranzfragebogen (UI-18) | Baseline | Questionnaire to measure tolerance to uncertainty |
| Resilienzskala (RS-13) - Baseline | Baseline | Questionnaire to measure resilience |
Countries
Germany
Contacts
Primary ContactJens Plag, Dr.
Backup ContactMartin Huemer, Dr.
Outcome results
None listed