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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03789929
Other study ID # ECCO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date July 31, 2020

Study information

Verified date February 2019
Source Charite University, Berlin, Germany
Contact Michael Jeitler, Dr.
Phone +49 30 80505 693
Email michael.jeitler@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date July 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Germany Charité Medical University, Department of Integrative Medicine at the Immanual Hospital Berlin Berlin-Zehlendorf 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 Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27) Assessing full scale, range 0-108, higher score meaning a better outcome 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
Secondary Saarbrücken Personality Questionnaire (SPF) based on the Interpersonal Reactivity Index (IRI) Assessing full scale, range 16-80, higher score meaning a better outcome 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
Secondary The World Health Organisation- Five Well-Being Index (WHO-5) Assessing full scale, range 0-100, higher score meaning a better outcome 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
Secondary General Self-efficacy Short Scale (ASKU) Assessing full scale, range 3-15, higher score meaning a better outcome 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
Secondary Hospital Anxiety and Depression Scale (HADS) Assessing full scale, range 0-42, lower score meaning a better outcome 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
Secondary Mindful Attention Awareness Scale (MAAS) Assessing full scale, range 15-90, higher score meaning a better outcome 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
Secondary Perceived Stress Scale (PSS-10) Assessing full scale, range 0-40, lower score meaning a better outcome 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
Secondary Medical Outcomes Study Short Form (MOS SF-36) Assessing full scale, range 0-100, higher score meaning a better outcome 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
Secondary Heart Rate Variability (HRV) 24h measuring Assessing change from baseline to 3 and 6 months after baseline in the yearly program
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