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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03790319
Other study ID # ECCT
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 several different face-to-face workshops about emotional competence and compassion are scientifically evaluated with psychometric questionnaires and heart rate variability measuring.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
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 Power of Feelings
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.
The Emotional Backpack
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.

Locations

Country Name City State
Germany Charité Medical University, Department of Integrative Medicine at the Immanual Hospital Berlin 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 The 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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