NCT03790319

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

December 14, 2018

Last Update Submit

February 11, 2019

Conditions

Keywords

StressEmotion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • The Saarbrücken Personality Questionnaire (SPF) based on the Interpersonal Reactivity Index (IRI)

    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

  • The World Health Organisation- Five Well-Being Index (WHO-5)

    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

  • General Self-efficacy Short Scale (ASKU)

    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)

    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)

    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

  • +3 more secondary outcomes

Study Arms (2)

Single Workshop 'The Emotional Backpack'

Subjects of this group are participating in one single workshop over three days.

Behavioral: The Emotional Backpack

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.

Behavioral: The Power of Feelings

Interventions

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.

Year Program 'The Power of Feelings'

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.

Single Workshop 'The Emotional Backpack'

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy adults who enrolled themselves from their own initiative into one of the included courses

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Medical University, Department of Integrative Medicine at the Immanual Hospital Berlin

Berlin, 14109, Germany

RECRUITING

Study Officials

  • Andreas Michalsen, Prof.

    Charite - Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 31, 2018

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

July 31, 2020

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations