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Emotional Competence and Compassion Online-Training (ECCO)

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ClinicalTrials.gov Identifier: NCT03789929
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany

Brief Summary:
In this study two different online-courses about emotional competence and compassion are scientifically evaluated with psychometric questionnaires and heart rate variability measuring.

Condition or disease Intervention/treatment
Emotional Intelligence Behavioral: The Emotional Backpack Behavioral: Feelings as Powers

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Scientific Evaluation of Online-Trainings for Emotional Competence, Compassion and Relationship Competences
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2020

Group/Cohort Intervention/treatment
The Emotional Backpack
Healthy adults participating in the offered online-course on their own initiative.
Behavioral: The Emotional Backpack
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.

Feelings as Powers
Healthy adults participating in the offered online-course on their own initiative.
Behavioral: Feelings as Powers
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.




Primary Outcome Measures :
  1. 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 ]
    Assessing full scale, range 0-108, higher score meaning a better outcome


Secondary Outcome Measures :
  1. 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 ]
    Assessing full scale, range 16-80, higher score meaning a better outcome

  2. 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 ]
    Assessing full scale, range 0-100, higher score meaning a better outcome

  3. 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 ]
    Assessing full scale, range 3-15, higher score meaning a better outcome

  4. 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 ]
    Assessing full scale, range 0-42, lower score meaning a better outcome

  5. 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 ]
    Assessing full scale, range 15-90, higher score meaning a better outcome

  6. 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 ]
    Assessing full scale, range 0-40, lower score meaning a better outcome

  7. 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 ]
    Assessing full scale, range 0-100, higher score meaning a better outcome

  8. Heart Rate Variability (HRV) [ Time Frame: Assessing change from baseline to 3 and 6 months after baseline in the yearly program ]
    24h measuring



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy adults who enrolled themselves from their own initiative into one of the included courses
Criteria

Inclusion Criteria:

  • 18-85 years
  • participation in one of the included courses
  • e-mail address

Exclusion Criteria:

  • participation in another study
  • no verbal communication (german) possible
  • dementia or another disease that limits cognitive abilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789929


Contacts
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Contact: Michael Jeitler, Dr. +49 30 80505 693 michael.jeitler@charite.de
Contact: Vanessa Bähr +49 176 32360472 vanessa.baehr@charite.de

Locations
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Germany
Charité Medical University, Department of Integrative Medicine at the Immanual Hospital Berlin Recruiting
Berlin-Zehlendorf, Berlin, Germany, 14109
Contact: Miriam Roesner    030 - 80505 - 682    m.roesner@immanuel.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Andreas Michalsen, prof. Dr. Charite - Universitätsmedizin Berlin

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Responsible Party: Andreas Michalsen, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03789929     History of Changes
Other Study ID Numbers: ECCO
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
Stress
Emotion