Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT06042595
Brief Summary:
The study aims to develop a prediction model of premature treatment termination in psychosomatic hospitals using a machine learning approach.
Detailed Description:
The aim of the study is to identify risk factors that lead to or predict premature treatment termination in psychosomatic hospitals. In the long-term, the study shall help to develop more precise prediction models that can enhance communication between therapists and patients about potential dropout and- if necessary- adaption of treatment in using a feedback loop.
Since it is still not clear which variables play a major role in predicting treatment termination in psychosomatic hospitals, the study design is exploratory and includes a broad range of intake patient characteristics. The purpose of this study is hereby, to develop a prediction model based on the information that are routinely assessed at intake. Therefore, three kind of variables are planned to be included: (1) demographic and other clinical variables (e.g. age, gender, ICD-10 diagnoses), (2) psychological questionnaire data (e.g. PHQ, SF-12, EB-45, IIP-32, OPD-SFK), and (3) physiological data (e.g. routine laboratory data, blood pressure). For the study, all patients that started inpatient psychotherapy at the medical centre Heidelberg between 2015 and January 2022 will be included, resulting in a sample size of approximately N = 2000. As the average dropout rate based on meta analytical results is around 20%, one can assume that up to 400 patients prematurely dropped out of treatment.
To calculate the prediction model, it is planned to use a machine learning approach which is highly functional in big data sets. Using a Random Forest Model for binary outcomes (regular treatment length vs. premature treatment termination) it is envisioned to identify variables that contribute to the prediction of premature treatment termination at intake. Additionally, waiting list effects will be considered by taking into account the waiting duration between the initial intake interview and the moment of the hospital admission. Therefore, the study will, for the first time, investigate a prediction model for premature treatment termination in inpatient psychotherapy including clinically relevant physiological data as well as waiting time effects in preparation of the psychosomatic treatment.
Study:
NCT06042595
Study Brief:
Protocol Section:
NCT06042595