NCT03789929

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.

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
400

participants targeted

Target at P75+ 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

Emotional Intelligence

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)

  • 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)

The Emotional Backpack

Healthy adults participating in the offered online-course on their own initiative.

Behavioral: The Emotional Backpack

Feelings as Powers

Healthy adults participating in the offered online-course on their own initiative.

Behavioral: Feelings as Powers

Interventions

The Emotional BackpackBEHAVIORAL

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.

The Emotional Backpack
Feelings as PowersBEHAVIORAL

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.

Feelings as Powers

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-Zehlendorf, State of Berlin, 14109, Germany

RECRUITING

Study Officials

  • Andreas Michalsen, prof. Dr.

    Charite - Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Jeitler, Dr.

CONTACT

+49 30 80505 693michael.jeitler@charite.de

Vanessa Bähr

CONTACT

+49 176 32360472vanessa.baehr@charite.de

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

DE(1)