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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06042595
Other study ID # Dropout-Prediction-2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date January 2022

Study information

Verified date September 2023
Source University Hospital Heidelberg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 2023
Est. completion date January 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - bipolar, acute psychotic or substance abuse disorder

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychotherapy
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Heidelberg

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
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