- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05120453
Interplay of Self-Criticism and Symptom Severity Over the Course of In-patient Psychotherapeutic Treatment (InSeCur)
November 2, 2021 updated by: Simone Jennissen, University Hospital Heidelberg
Assessment of the Interplay Between Self-critisim and Symptom Severity Over the Course of In-patient Psychotherapeutic Treatment
The purpose of this study is to assess the interplay between self-criticism and symptom severity in patients undergoing psychotherapeutic treatment.
Study Overview
Status
Completed
Detailed Description
Participants are recruited at the University Clinic Heidelberg at the beginning of their (usually) 8-week in-patient treatment, consisting of somatic and psychotherapeutic aspects.
After informed consent, patients routinely fill out weekly questionnaires about their self-criticism and their symptom severity.
The overall aim of this study is to disentangle stable (between-person) effects of both self-criticism and symptom severity from within-person effects happening over time in order to better understand what drives what, or in other words, their dynamic interplay.
The analysis is based on the weekly assessment of the patients.
All patients receive the standard care of the in-patient treatment.
Study Type
Observational
Enrollment (Actual)
2778
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
Inclusion Criteria:
- Undergoing in-patient treatment at the University Clinic Heidelberg (Klinik für Allgemeine Innere Medizin und Psychosomatik)
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SCL-K11
Time Frame: Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks)
|
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
Time Frame: Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ulrike Dinger, Prof, University Hospital Heidelberg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
March 30, 2021
Study Completion (Actual)
March 30, 2021
Study Registration Dates
First Submitted
November 2, 2021
First Submitted That Met QC Criteria
November 2, 2021
First Posted (Actual)
November 15, 2021
Study Record Updates
Last Update Posted (Actual)
November 15, 2021
Last Update Submitted That Met QC Criteria
November 2, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ST-TDEQSCL-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.