- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790319
Emotional Competence and Compassion Training (ECCT)
Scientific Evaluation of Trainings for Emotional Competence, Compassion and Relationship Competences
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Berlin, Germany, 14109
- Recruiting
- Charité Medical University, Department of Integrative Medicine at the Immanual Hospital Berlin
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Contact:
- Miriam Rösner
- Phone Number: 030 - 80505 - 682
- Email: m.roesner@immanuel.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single Workshop 'The Emotional Backpack'
Subjects of this group are participating in one single workshop over three days.
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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. |
|
Year Program 'The Power of Feelings'
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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Assessing full scale, range 0-108, higher score meaning a better outcome
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
|
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
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Assessing full scale, range 0-42, lower score meaning a better outcome
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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
|
|
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
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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
|
|
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
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Assessing full scale, range 0-40, lower score meaning a better outcome
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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
|
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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
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Assessing full scale, range 0-100, higher score meaning a better outcome
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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
|
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Heart Rate Variability (HRV)
Time Frame: Assessing change from baseline to 3 and 6 months after baseline in the yearly program
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24h measuring
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Assessing change from baseline to 3 and 6 months after baseline in the yearly program
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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
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Assessing full scale, range 16-80, higher score meaning a better outcome
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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
|
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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
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andreas Michalsen, Prof., Charité - Universitätsmedizin Berlin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.