NCT06042595

Brief Summary

The study aims to develop a prediction model of premature treatment termination in psychosomatic hospitals using a machine learning approach.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,023

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
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

7 years

First QC Date

August 11, 2023

Last Update Submit

September 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Premature treatment termination (vs. treatment completion)

    Premature treatment termination will be classified based on the treatment duration. Classification will be made retrospectively for each patient based on the duration of the inpatient treatment and if applicable (duration \< 49 days) on the hospital discharge letter to screen for reasons of the shorter treatment duration.

    Premature treatment termination will be operationalized as a dummy variable. Regular treatment duration is 8 weeks of inpatient psychotherapy. Data will be reported for 7 years of continuous study enrolment (01/2015 - 01/2022).

Interventions

PsychotherapyBEHAVIORAL

Patients treated at the inpatient psychotherapy unit of the University Hospital receive 8 to 10 weeks of multimodal psychotherapeutic treatment. Treatment consists of individual as well as group psychodynamic therapy. Additionally, patients receive an individual combination of music, art, relaxation and body-oriented group therapy. Therapeutic treatment is provided by a multiprofessional, interdisciplinary team of psychotherapists with either a medical or psychology degree, art and music therapists, specialist nurses, social workers, and physiotherapists.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients being treated at the inpatient unit of University Hospital Heidelberg, department for psychosomatic medicine.

You may qualify if:

  • patients of at least 18 years of age
  • included in inpatient psychotherapy treatment program in a hospital for psychosomatic medicine
  • provided information about admission and discharge date

You may not qualify if:

  • bipolar, acute psychotic or substance abuse disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Ulrike Dinger-Ehrenthal, Prof. Dr.

    Department of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Heinrich-Heine University Düsseldorf

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2023

First Posted

September 18, 2023

Study Start

January 1, 2015

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because study data is provided by mental health patients and is therefore subject to strict protection.