to study search History

My inner Team - Cloud Service

Organizational Data

DRKS-ID:
DRKS00030491
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2022-10-19
Last update in DRKS:
2022-10-20
Registration type:
Retrospective

Acronym/abbreviation of the study

MiT-2020

URL of the study

https://www.meeves.de/studie

Brief summary in lay language

Brief Description: It is an autonomously functioning cloud service (web application). The purpose of the software is to preventively and / or acutely reduce chronic stress and build resilience. The person using it goes through an individual coaching process following a systematic approach and without human supervision. The study is to verify whether even a single session yields significant health benefits for the user. It compares whether the person feels better after the session than before the session (precisely: whether the session helped). The background to this is to have applications that build on each other certified as a "course" in a further development step (§20 SBG V - Zentrale Prüfstelle Prävention der Krankenkassen). Study participants: These are anonymous adult users to whom the program was offered for free use without announcement and without preparation within the framework of an e-mail distribution list. Optionally, a questionnaire could be filled out at the end. Hypothesis: The program is designed to enable a process of awareness. The person using the program learns something new about himself and learns to systemically reorganize his "inner team". As a result, resources become available and emotions are processed. The person feels better, which has a positive effect on his resilience factors. This is to be verified by questioning.

Brief summary in scientific language

proof of effectiveness and functionality, User experience of Cloud Software: My inner Team

Health condition or problem studied

Free text:
healthy subjects
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
Normal average randomly selected adult people have the opportunity to go through a coaching process. It can be assumed that people do not suffer from severe mental disorders.

Endpoints

Primary outcome:
The aim is to find out whether even a single complete psychological coaching can have a health benefit for a user. Immediately after the session, it is measured whether the session has helped the person in terms of the initial state or not. At the end of the session, a questionnaire will be offered for the measurement. Target group: Adults, Internet-savvy, German-speaking people without severe psychological symptoms.
Secondary outcome:
This is a single-endpoint, reprospective study.

Study Design

Purpose:
Prevention
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other / Privaträume der anwendenden Menschen

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2022-03-01
Planned study completion date:
No Entry
Actual Study Completion Date:
2022-10-12
Target Sample Size:
1309
Final Sample Size:
1309

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
internet capable, German language

Exclusion Criteria

severe mental symptoms

Addresses

Primary Sponsor

Mindful Digital Products
Hans-Jürgen Meeves
Binnenfeldredder 42
21031 Hamburg
Germany
Telephone:
04072104688
Fax:
No Entry
Contact per E-Mail
URL:
http://www.meeves.de
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

eigene Praxis
Prof. Dr. med. Jürgen Sperner
Lindenplatz 6
23554 Lübeck
Germany
Telephone:
0451-38444930
Fax:
0451-3844490
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Mindful Digital Products
Hans-Jürgen Meeves
Binnenfeldredder 42
21031 Hamburg
Germany
Telephone:
04072104688
Fax:
No Entry
Contact per E-Mail
URL:
http://www.meeves.de

Principal Investigator

eigene Praxis
Prof. Dr. med. Jürgen Sperner
Lindenplatz 6
23554 Lübeck
Germany
Telephone:
0451-38444930
Fax:
0451-3844490
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Mindful Digital Products
Binnenfeldredder 42
21031 Hamburg
Germany
Telephone:
04072104688
Fax:
No Entry
Contact per E-Mail
URL:
http://www.meeves.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Ärztekammer Hamburg
Weidestraße 122 b
22083 Hamburg
Germany
Telephone:
+49-40-2022990
Fax:
+40-40-202299410
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-09-20
Ethics committee number:
2022-300253-WF
Vote of the Ethics Committee:
No approval required according to the EC
Date of the vote:
2022-09-26

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
unique selling points

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry