NCT05120453

Brief Summary

The purpose of this study is to assess the interplay between self-criticism and symptom severity in patients undergoing psychotherapeutic treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,778

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

6.2 years

First QC Date

November 2, 2021

Last Update Submit

November 2, 2021

Conditions

Self-CriticismPsychological DistressIn-Patient Treatment

Outcome Measures

Primary Outcomes (2)

  • SCL-K11

    Symptom Check-List German Short Version with 11 Items

    Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks)

  • TDEQ-12 (Subscale Self-Criticism

    Theoretical Depressive Experiences Questionnaire German Short Version with 12 Items: Subscale Self-Criticism

    Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks)

Eligibility Criteria

Age17 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients undergoing in-patient treatment at the university clinic Heidelberg. The psychosomatic clinic treats patients over the course of (usually) 8 weeks.

You may qualify if:

  • Undergoing in-patient treatment at the University Clinic Heidelberg (Klinik für Allgemeine Innere Medizin und Psychosomatik)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ulrike Dinger, Prof

    University Hospital Heidelberg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 15, 2021

Study Start

January 1, 2015

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share