<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/NCT03789929</url>
  </required_header>
  <id_info>
    <org_study_id>ECCO</org_study_id>
    <nct_id>NCT03789929</nct_id>
  </id_info>
  <brief_title>Emotional Competence and Compassion Online-Training</brief_title>
  <acronym>ECCO</acronym>
  <official_title>Scientific Evaluation of Online-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 two different online-courses about emotional competence and compassion are&#xD;
      scientifically evaluated with psychometric questionnaires and heart rate variability&#xD;
      measuring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stress and stress related diseases are becoming 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 online-courses about emotional competence and compassion are&#xD;
      scientifically evaluated with psychometric questionnaires and heart rate variability&#xD;
      measuring. The courses are planned by the trainers and people register on their own&#xD;
      initiative.&#xD;
&#xD;
      The courses have a duration of 4 weeks or three months. They consist of video lectures that&#xD;
      explain the content as well as videos giving exercises about the character of the different&#xD;
      feelings and about the characteristics of emotions. They teach practices on how to use&#xD;
      feelings as an empowering force in life and how to deal 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>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">400</enrollment>
  <condition>Emotional Intelligence</condition>
  <arm_group>
    <arm_group_label>The Emotional Backpack</arm_group_label>
    <description>Healthy adults participating in the offered online-course on their own initiative.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Feelings as Powers</arm_group_label>
    <description>Healthy adults participating in the offered online-course on their own initiative.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Emotional Backpack</intervention_name>
    <description>In this 4 weeks course participants learn how to process difficult emotions that has been overwhelming in the past. They learn how they can use the support of other people and support other people in the processing emotions within a simple and easy to learn setting.</description>
    <arm_group_label>The Emotional Backpack</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Feelings as Powers</intervention_name>
    <description>In this 3 months course participants learn about the empowering potential of their feelings as well as the difficult aspects of them. In addition to that they learn techniques how to deal with difficult emotions.</description>
    <arm_group_label>Feelings as Powers</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. Dr.</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-Zehlendorf</city>
        <state>Berlin</state>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miriam Roesner</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/NCT03789929
org study id: ECCO
nct id: NCT03789929
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study two different online-courses about emotional competence and compassion are
      scientifically evaluated with psychometric questionnaires and heart rate variability
      measuring.
Stress and stress related diseases are becoming 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 online-courses about emotional competence and compassion are
      scientifically evaluated with psychometric questionnaires and heart rate variability
      measuring. The courses are planned by the trainers and people register on their own
      initiative.

      The courses have a duration of 4 weeks or three months. They consist of video lectures that
      explain the content as well as videos giving exercises about the character of the different
      feelings and about the characteristics of emotions. They teach practices on how to use
      feelings as an empowering force in life and how to deal 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: 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: The Emotional Backpack
description: Healthy adults participating in the offered online-course on their own initiative.
arm group label: Feelings as Powers
description: Healthy adults participating in the offered online-course on their own initiative.
intervention type: Behavioral
intervention name: The Emotional Backpack
description: In this 4 weeks course participants learn how to process difficult emotions that has been overwhelming in the past. They learn how they can use the support of other people and support other people in the processing emotions within a simple and easy to learn setting.
arm group label: The Emotional Backpack
intervention type: Behavioral
intervention name: Feelings as Powers
description: In this 3 months course participants learn about the empowering potential of their feelings as well as the difficult aspects of them. In addition to that they learn techniques how to deal with difficult emotions.
arm group label: Feelings as Powers
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. Dr.
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