Psychometric Characterization of Patients With Cardiac Arrhythmias

Depression Clinical Trial

— Be-PART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474418
• Other study ID #: EA2/211/17
• Status: Recruiting
• Start date: October 9, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2020
• Source: Charite University, Berlin, Germany
• Contact: Jens Plag, Dr.
• Phone: +49 30 450 510 306
• Email: jens.plag[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Depression
• Personality
• Psychological Stress
• Stress, Psychological

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NEO-FFI personality inventory	personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness	Only at baseline
Secondary	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
Secondary	Heart beat Counting Task by Schandry	Assessment of patients heart beat perception	Baseline
Secondary	Angstkontrollfragebogen (AKF) - Baseline	AKF is the German Version of the Anxiety Control Questionnaire	Baseline before standard therapy
Secondary	Angstkontrollfragebogen (AKF) - 3 months after standard therapy	AKF is the German Version of the Anxiety Control Questionnaire	3 months after standard therapy
Secondary	Angstkontrollfragebogen (AKF) - 6 months after standard therapy	AKF is the German Version of the Anxiety Control Questionnaire	6 months after standard therapy
Secondary	Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI)	ASI is a Questionnaire measuring anxiety sensitivity	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Heart rate variability - Baseline	heart rate variability is a non-invasive method to measure autonomic nervous system function	Baseline before standard therapy
Secondary	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
Secondary	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
Secondary	Resilienzskala (RS-13) - Baseline	Questionnaire to measure resilience	Baseline
Secondary	Resilienzskala (RS-13) - 3 months after standard therapy	Questionnaire to measure resilience	3 months after standard therapy
Secondary	Resilienzskala (RS-13) - 6 months after standard therapy	Questionnaire to measure resilience	6 months after standard therapy
Secondary	Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline	Questionnaire to measure self-efficacy	Baseline
Secondary	Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy	Questionnaire to measure self-efficacy	3 months after standard therapy
Secondary	Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy	Questionnaire to measure self-efficacy	6 months after standard therapy
Secondary	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
Secondary	Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months	Questionnaire to measure psychological stress perception	From Baseline at 6 months after standard therapy
Secondary	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
Secondary	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
Secondary	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
Secondary	Euroquol EQ-5D-3L - Change from Baseline at 6	Questionnaire to measure quality of life	From Baseline at 6 months after standard therapy
Secondary	Unsicherheitsintoleranzfragebogen (UI-18)	Questionnaire to measure tolerance to uncertainty	Baseline