Self-CriticismInSeCurNCT05120453
Interplay of Self-Criticism and Symptom Severity Over the Course of In-patient Psychotherapeutic Treatment
An observational study of Self-Criticism and Psychological Distress, run by University Hospital Heidelberg.
Trial summary
The purpose of this study is to assess the interplay between self-criticism and symptom severity in patients undergoing psychotherapeutic treatment. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Self-Criticism, Psychological Distress, In-Patient Treatment
- How many people
- 2,778 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Mar 2021
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Undergoing in-patient treatment at the University Clinic Heidelberg (Klinik für Allgemeine Innere Medizin und Psychosomatik)
Who cannot join
- none
About this study
Official title: 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.
Read the 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.
- Conditions
- Self-Criticism, Psychological Distress, In-Patient Treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
SCL-K11
Symptom Check-List German Short Version with 11 Items
Measured: 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
Measured: Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Jan 2015
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-CriticismStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,778 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Jennissen, University Hospital Heidelberg
- Investigators
- Ulrike Dinger, Prof, Study chair, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120453
- Sponsor's protocol ID
- ST-TDEQSCL-2021
- Acronym
- InSeCur
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Interplay Between Self-critisim and Symptom Severity Over the Course of In-patient Psychotherapeutic Treatment
- ClinicalTrials.gov ID
- NCT05120453
- Acronym / sponsor ID
- InSeCur / ST-TDEQSCL-2021
- Conditions
- Self-Criticism, Psychological Distress, In-Patient Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,778 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the interplay between self-criticism and symptom severity in patients undergoing psychotherapeutic treatment.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Undergoing in-patient treatment at the University Clinic Heidelberg (Klinik für Allgemeine Innere Medizin und Psychosomatik)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Self-Criticism
Recruiting
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Rumination, Worry
Recruiting
Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion
Post-traumatic Stress Disorder (PTSD)
Recruiting
Brief Interventions for Coping with Distress
Distress, Emotional, Emotional Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Dinger, Prof study chair
University Hospital Heidelberg
Questions about this trial
What is this clinical trial studying?
An observational study of Self-Criticism and Psychological Distress, run by University Hospital Heidelberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCL-K11 (time frame: Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.