<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04474418</url>
  </required_header>
  <id_info>
    <org_study_id>EA2/211/17</org_study_id>
    <nct_id>NCT04474418</nct_id>
  </id_info>
  <brief_title>Psychometric Characterization of Patients With Cardiac Arrhythmias</brief_title>
  <acronym>Be-PART</acronym>
  <official_title>Be-PART: Berlin Psychometric Characterization of Patients With Cardiac ARrhyThmias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the influence of different psychological parameters (e.g. depression, anxiety,&#xD;
      personality traits, resilience, tolerance of uncertainty or heart beat perception) on&#xD;
      treatment outcome and quality of life in patients with cardiac arrythmias.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This longitudinal observational study examines patients with cardiac arrhythmia (such as&#xD;
      atrial fibrillation or atrial flutter) who are undergoing a conventional standard therapy in&#xD;
      the Department of Cardiology of the Charité - Universitätsmedizin Berlin, Campus Benjamin&#xD;
      Franklin. To examine the impact of psychological symptoms such as anxiety, depression,&#xD;
      resilience and risk factors (e.g. neuroticism) on cardiac treatment outcomes, patients are&#xD;
      evaluated with a standardized psychological assessment including established questionnaires.&#xD;
      The baseline observation is performed before the standard treatment of the arrhythmia (e.g.&#xD;
      pharmacological treatment or electrophysiological methods). Follow-up observations are made 3&#xD;
      and 6 month after the cardiological intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 9, 2018</start_date>
  <completion_date type="Anticipated">August 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Beck Depression Inventory (BDI) - Change from Baseline at 6 months</measure>
    <time_frame>From Baseline at 6 months (Follow-up) after standard therapy</time_frame>
    <description>BDI is a questionnaire measuring depression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NEO-FFI personality inventory</measure>
    <time_frame>Only at baseline</time_frame>
    <description>personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiography (ECG) - Change from Baseline at 6 months</measure>
    <time_frame>From Baseline at 6 months (Follow-up) after standard therapy</time_frame>
    <description>measuring heart activity and signs of cardiac arrhythmias</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart beat Counting Task by Schandry</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessment of patients heart beat perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angstkontrollfragebogen (AKF) - Baseline</measure>
    <time_frame>Baseline before standard therapy</time_frame>
    <description>AKF is the German Version of the Anxiety Control Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angstkontrollfragebogen (AKF) - 3 months after standard therapy</measure>
    <time_frame>3 months after standard therapy</time_frame>
    <description>AKF is the German Version of the Anxiety Control Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angstkontrollfragebogen (AKF) - 6 months after standard therapy</measure>
    <time_frame>6 months after standard therapy</time_frame>
    <description>AKF is the German Version of the Anxiety Control Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI)</measure>
    <time_frame>Baseline</time_frame>
    <description>ASI is a Questionnaire measuring anxiety sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI)</measure>
    <time_frame>3 months after standard therapy</time_frame>
    <description>ASI is a Questionnaire measuring anxiety sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Sensitivity Index (ASI) - 6 months after standard therapy Anxiety Sensitivity Index (ASI)</measure>
    <time_frame>6 months after standard therapy</time_frame>
    <description>ASI is a Questionnaire measuring anxiety sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months</measure>
    <time_frame>From Baseline at 6 months (Follow-up) after standard therapy</time_frame>
    <description>BAI is a questionnaire measuring anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability - Baseline</measure>
    <time_frame>Baseline before standard therapy</time_frame>
    <description>heart rate variability is a non-invasive method to measure autonomic nervous system function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability - 3 months after standard therapy</measure>
    <time_frame>3 months after standard therapy</time_frame>
    <description>heart rate variability is a non-invasive method to measure autonomic nervous system function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability - 6 months after standard therapy</measure>
    <time_frame>6 months after Standardtherapie</time_frame>
    <description>heart rate variability is a non-invasive method to measure autonomic nervous system function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilienzskala (RS-13) - Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire to measure resilience</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilienzskala (RS-13) - 3 months after standard therapy</measure>
    <time_frame>3 months after standard therapy</time_frame>
    <description>Questionnaire to measure resilience</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilienzskala (RS-13) - 6 months after standard therapy</measure>
    <time_frame>6 months after standard therapy</time_frame>
    <description>Questionnaire to measure resilience</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire to measure self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy</measure>
    <time_frame>3 months after standard therapy</time_frame>
    <description>Questionnaire to measure self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy</measure>
    <time_frame>6 months after standard therapy</time_frame>
    <description>Questionnaire to measure self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months</measure>
    <time_frame>From Baseline at 6 months after standard therapy</time_frame>
    <description>Questionnaire to assess symptoms of psychiatric disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months</measure>
    <time_frame>From Baseline at 6 months after standard therapy</time_frame>
    <description>Questionnaire to measure psychological stress perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months</measure>
    <time_frame>From Baseline at 6 months after standard therapy</time_frame>
    <description>Questionnaire to measure body sensations related to anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Herzangstfragebogen (HAF-17) - Change from Baseline at 6</measure>
    <time_frame>From Baseline at 6 months after standard therapy</time_frame>
    <description>Questionnaire to measure anxiety with respect to cardiac symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fragebogen zu Akzeptanz und Handeln II (FAH-II) - Change from Baseline at 6 months</measure>
    <time_frame>From Baseline at 6 months after standard therapy</time_frame>
    <description>Questionnaire to measure psychological flexibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Euroquol EQ-5D-3L - Change from Baseline at 6</measure>
    <time_frame>From Baseline at 6 months after standard therapy</time_frame>
    <description>Questionnaire to measure quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unsicherheitsintoleranzfragebogen (UI-18)</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire to measure tolerance to uncertainty</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cardiac Arrhythmia</condition>
  <condition>Anxiety</condition>
  <condition>Personality</condition>
  <condition>Psychological Stress</condition>
  <condition>Depression</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with cardiac arrythmias without any signs of medium or severe cognitive&#xD;
        dysfunction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of majority (min. 18 years old)&#xD;
&#xD;
          -  no severe cognitive dysfunction&#xD;
&#xD;
          -  diagnosed cardiac arrhythmias&#xD;
&#xD;
          -  reason of admission is the treatment of cardiac arrhythmia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medium to severe cognitive dysfunction&#xD;
&#xD;
          -  doubt on capacity to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jens Plag, Dr.</last_name>
    <phone>+49 30 450 510 306</phone>
    <email>jens.plag@charite.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martin Huemer, Dr.</last_name>
    <email>martin.huemer@charite.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Plag, Dr.</last_name>
      <phone>0049 30 450 517306</phone>
      <email>jens.plag@charite.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Dr. Jens Plag</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>cardiac arrhythmia, personality, psychological symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04474418
org study id: EA2/211/17
nct id: NCT04474418
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Beck Depression Inventory (BDI) - Change from Baseline at 6 months
time frame: From Baseline at 6 months (Follow-up) after standard therapy
description: BDI is a questionnaire measuring depression
measure: NEO-FFI personality inventory
time frame: Only at baseline
description: personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness
measure: Electrocardiography (ECG) - Change from Baseline at 6 months
time frame: From Baseline at 6 months (Follow-up) after standard therapy
description: measuring heart activity and signs of cardiac arrhythmias
measure: Heart beat Counting Task by Schandry
time frame: Baseline
description: Assessment of patients heart beat perception
measure: Angstkontrollfragebogen (AKF) - Baseline
time frame: Baseline before standard therapy
description: AKF is the German Version of the Anxiety Control Questionnaire
measure: Angstkontrollfragebogen (AKF) - 3 months after standard therapy
time frame: 3 months after standard therapy
description: AKF is the German Version of the Anxiety Control Questionnaire
measure: Angstkontrollfragebogen (AKF) - 6 months after standard therapy
time frame: 6 months after standard therapy
description: AKF is the German Version of the Anxiety Control Questionnaire
measure: Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI)
time frame: Baseline
description: ASI is a Questionnaire measuring anxiety sensitivity
measure: Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI)
time frame: 3 months after standard therapy
description: ASI is a Questionnaire measuring anxiety sensitivity
measure: Anxiety Sensitivity Index (ASI) - 6 months after standard therapy Anxiety Sensitivity Index (ASI)
time frame: 6 months after standard therapy
description: ASI is a Questionnaire measuring anxiety sensitivity
measure: Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months
time frame: From Baseline at 6 months (Follow-up) after standard therapy
description: BAI is a questionnaire measuring anxiety
measure: Heart rate variability - Baseline
time frame: Baseline before standard therapy
description: heart rate variability is a non-invasive method to measure autonomic nervous system function
measure: Heart rate variability - 3 months after standard therapy
time frame: 3 months after standard therapy
description: heart rate variability is a non-invasive method to measure autonomic nervous system function
measure: Heart rate variability - 6 months after standard therapy
time frame: 6 months after Standardtherapie
description: heart rate variability is a non-invasive method to measure autonomic nervous system function
measure: Resilienzskala (RS-13) - Baseline
time frame: Baseline
description: Questionnaire to measure resilience
measure: Resilienzskala (RS-13) - 3 months after standard therapy
time frame: 3 months after standard therapy
description: Questionnaire to measure resilience
measure: Resilienzskala (RS-13) - 6 months after standard therapy
time frame: 6 months after standard therapy
description: Questionnaire to measure resilience
measure: Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline
time frame: Baseline
description: Questionnaire to measure self-efficacy
measure: Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy
time frame: 3 months after standard therapy
description: Questionnaire to measure self-efficacy
measure: Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy
time frame: 6 months after standard therapy
description: Questionnaire to measure self-efficacy
measure: ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months
time frame: From Baseline at 6 months after standard therapy
description: Questionnaire to assess symptoms of psychiatric disorders
measure: Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months
time frame: From Baseline at 6 months after standard therapy
description: Questionnaire to measure psychological stress perception
measure: Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months
time frame: From Baseline at 6 months after standard therapy
description: Questionnaire to measure body sensations related to anxiety
measure: Herzangstfragebogen (HAF-17) - Change from Baseline at 6
time frame: From Baseline at 6 months after standard therapy
description: Questionnaire to measure anxiety with respect to cardiac symptoms
measure: Fragebogen zu Akzeptanz und Handeln II (FAH-II) - Change from Baseline at 6 months
time frame: From Baseline at 6 months after standard therapy
description: Questionnaire to measure psychological flexibility
measure: Euroquol EQ-5D-3L - Change from Baseline at 6
time frame: From Baseline at 6 months after standard therapy
description: Questionnaire to measure quality of life
measure: Unsicherheitsintoleranzfragebogen (UI-18)
time frame: Baseline
description: Questionnaire to measure tolerance to uncertainty
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Plag, Dr.
phone: +49 30 450 510 306
email: jens.plag@charite.de
last name: Martin Huemer, Dr.
email: martin.huemer@charite.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Dr. Jens Plag
investigator title: MD
mesh term: Arrhythmias, Cardiac
mesh term: Stress, Psychological
sharing ipd: Undecided