<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/NCT03790319</url>
  </required_header>
  <id_info>
    <org_study_id>ECCT</org_study_id>
    <nct_id>NCT03790319</nct_id>
  </id_info>
  <brief_title>Emotional Competence and Compassion Training</brief_title>
  <acronym>ECCT</acronym>
  <official_title>Scientific Evaluation of Trainings for Emotional Competence, Compassion and Relationship Competences</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>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study several different face-to-face workshops about emotional competence and&#xD;
      compassion are scientifically evaluated with psychometric questionnaires and heart rate&#xD;
      variability measuring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stress and stress related diseases are a huge health burden in modern societies.&#xD;
      Psycho-emotional stress plays a key role in stress regulation. Therefore this study aims to&#xD;
      investigate the effects of online-courses addressing emotion regulation.&#xD;
&#xD;
      For this aim several different workshops about emotional competence and compassion are&#xD;
      scientifically evaluated with psychometric questionnaires and heart rate variability&#xD;
      measuring. The workshops are planned by the trainers and people register on their own&#xD;
      initiative.&#xD;
&#xD;
      The seminars are either single workshops over three days or a yearly program consisting of&#xD;
      three three-day-workshops. They consist of lectures and exercises about the character of the&#xD;
      different feelings, about the characteristics of emotions and teach practices on how to dael&#xD;
      with difficult emotions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27)</measure>
    <time_frame>Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program</time_frame>
    <description>Assessing full scale, range 0-108, higher score meaning a better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Saarbrücken Personality Questionnaire (SPF) based on the Interpersonal Reactivity Index (IRI)</measure>
    <time_frame>Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program</time_frame>
    <description>Assessing full scale, range 16-80, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The World Health Organisation- Five Well-Being Index (WHO-5)</measure>
    <time_frame>Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program</time_frame>
    <description>assessing full scale, range 0-100, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Self-efficacy Short Scale (ASKU)</measure>
    <time_frame>Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program</time_frame>
    <description>Assessing full scale, range 3-15, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program</time_frame>
    <description>Assessing full scale, range 0-42, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful Attention Awareness Scale (MAAS)</measure>
    <time_frame>Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program</time_frame>
    <description>Assessing full scale, range 15-90, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS-10)</measure>
    <time_frame>Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program</time_frame>
    <description>Assessing full scale, range 0-40, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Short Form (MOS SF-36)</measure>
    <time_frame>Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program</time_frame>
    <description>Assessing full scale, range 0-100, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability (HRV)</measure>
    <time_frame>Assessing change from baseline to 3 and 6 months after baseline in the yearly program</time_frame>
    <description>24h measuring</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Emotional Intelligence</condition>
  <arm_group>
    <arm_group_label>Single Workshop 'The Emotional Backpack'</arm_group_label>
    <description>Subjects of this group are participating in one single workshop over three days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Year Program 'The Power of Feelings'</arm_group_label>
    <description>Subjects of this group are participating in three workshops of over 3 days each in a continuing group over nine months. They are animated to deal with the content inbetween the workshops through biweekly e-mails and to exchange in couples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Power of Feelings</intervention_name>
    <description>Three workshops of three days each teach about the five basic feelings rage, sadness, fear, shame and joy and talk about the powerful and destructive qualities they can have. In addition to that they are about how to deal with emotions, which are defined as unfelt feelings of the past.&#xD;
Smaller lectures give the participants an overview about the themes. Through exercises the participants can make experiences p.e. about each of the feelings. Another element is the sharing in dyads or small groups about actual feelings to practice emotional disclosure and to build a culture of openness and compassion.</description>
    <arm_group_label>Year Program 'The Power of Feelings'</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Emotional Backpack</intervention_name>
    <description>One workshop of three days teach about how to deal with emotions, which are defined as unfelt feelings of the past. They show a way to work in couples with a form of emotional disclosure that helps process emotions that have been overwhelming in the past.&#xD;
Smaller lectures give the participants an overview about the themes. Through exercises the participants can make experiences p.e. about each of the feelings. Another element is the sharing in dyads or small groups about actual feelings to practice emotional disclosure and to build a culture of openness and compassion.</description>
    <arm_group_label>Single Workshop 'The Emotional Backpack'</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        healthy adults who enrolled themselves from their own initiative into one of the included&#xD;
        courses&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-85 years&#xD;
&#xD;
          -  participation in one of the included courses&#xD;
&#xD;
          -  e-mail address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participation in another study&#xD;
&#xD;
          -  no verbal communication (german) possible&#xD;
&#xD;
          -  dementia or another disease that limits cognitive abilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Michalsen, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite - Universitätsmedizin Berlin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Jeitler, Dr.</last_name>
    <phone>+49 30 80505 693</phone>
    <email>michael.jeitler@charite.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vanessa Bähr</last_name>
    <phone>+49 176 32360472</phone>
    <email>vanessa.baehr@charite.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Charité Medical University, Department of Integrative Medicine at the Immanual Hospital Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miriam Rösner</last_name>
      <phone>030 - 80505 - 682</phone>
      <email>m.roesner@immanuel.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Andreas Michalsen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Emotion</keyword>
  <!-- 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/NCT03790319
org study id: ECCT
nct id: NCT03790319
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study several different face-to-face workshops about emotional competence and
      compassion are scientifically evaluated with psychometric questionnaires and heart rate
      variability measuring.
Stress and stress related diseases are a huge health burden in modern societies.
      Psycho-emotional stress plays a key role in stress regulation. Therefore this study aims to
      investigate the effects of online-courses addressing emotion regulation.

      For this aim several different workshops about emotional competence and compassion are
      scientifically evaluated with psychometric questionnaires and heart rate variability
      measuring. The workshops are planned by the trainers and people register on their own
      initiative.

      The seminars are either single workshops over three days or a yearly program consisting of
      three three-day-workshops. They consist of lectures and exercises about the character of the
      different feelings, about the characteristics of emotions and teach practices on how to dael
      with difficult emotions.
observational model: Cohort
time perspective: Prospective
measure: Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27)
time frame: Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program
description: Assessing full scale, range 0-108, higher score meaning a better outcome
measure: The Saarbrücken Personality Questionnaire (SPF) based on the Interpersonal Reactivity Index (IRI)
time frame: Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program
description: Assessing full scale, range 16-80, higher score meaning a better outcome
measure: The World Health Organisation- Five Well-Being Index (WHO-5)
time frame: Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program
description: assessing full scale, range 0-100, higher score meaning a better outcome
measure: General Self-efficacy Short Scale (ASKU)
time frame: Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program
description: Assessing full scale, range 3-15, higher score meaning a better outcome
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program
description: Assessing full scale, range 0-42, lower score meaning a better outcome
measure: Mindful Attention Awareness Scale (MAAS)
time frame: Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program
description: Assessing full scale, range 15-90, higher score meaning a better outcome
measure: Perceived Stress Scale (PSS-10)
time frame: Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program
description: Assessing full scale, range 0-40, lower score meaning a better outcome
measure: Medical Outcomes Study Short Form (MOS SF-36)
time frame: Assessing change from baseline to 3 months and 6 months after baseline in single workshops and baseline to 3, 6, 9 and 12 months after baseline in the yearly program
description: Assessing full scale, range 0-100, higher score meaning a better outcome
measure: Heart Rate Variability (HRV)
time frame: Assessing change from baseline to 3 and 6 months after baseline in the yearly program
description: 24h measuring
arm group label: Single Workshop 'The Emotional Backpack'
description: Subjects of this group are participating in one single workshop over three days.
arm group label: Year Program 'The Power of Feelings'
description: Subjects of this group are participating in three workshops of over 3 days each in a continuing group over nine months. They are animated to deal with the content inbetween the workshops through biweekly e-mails and to exchange in couples.
intervention type: Behavioral
intervention name: The Power of Feelings
description: Three workshops of three days each teach about the five basic feelings rage, sadness, fear, shame and joy and talk about the powerful and destructive qualities they can have. In addition to that they are about how to deal with emotions, which are defined as unfelt feelings of the past.
Smaller lectures give the participants an overview about the themes. Through exercises the participants can make experiences p.e. about each of the feelings. Another element is the sharing in dyads or small groups about actual feelings to practice emotional disclosure and to build a culture of openness and compassion.
arm group label: Year Program 'The Power of Feelings'
intervention type: Behavioral
intervention name: The Emotional Backpack
description: One workshop of three days teach about how to deal with emotions, which are defined as unfelt feelings of the past. They show a way to work in couples with a form of emotional disclosure that helps process emotions that have been overwhelming in the past.
Smaller lectures give the participants an overview about the themes. Through exercises the participants can make experiences p.e. about each of the feelings. Another element is the sharing in dyads or small groups about actual feelings to practice emotional disclosure and to build a culture of openness and compassion.
arm group label: Single Workshop 'The Emotional Backpack'
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Michalsen, Prof.
role: Principal Investigator
affiliation: Charite - Universitätsmedizin Berlin
last name: Michael Jeitler, Dr.
phone: +49 30 80505 693
email: michael.jeitler@charite.de
last name: Vanessa Bähr
phone: +49 176 32360472
email: vanessa.baehr@charite.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Andreas Michalsen
investigator title: Principal Investigator