NCT05240105

Brief Summary

This study aims to evaluate the so-called platform model and its suitability to determine staffing in hospitals for psychosomatic medicine and psychotherapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,961

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 11, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

January 31, 2022

Last Update Submit

February 10, 2022

Conditions

Outcome Measures

Primary Outcomes (8)

  • Administered Treatments

    units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists

    Week one of treatment: assessment of administered treatment units

  • Administered Treatments

    units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists

    Week two of treatment: assessment of administered treatment units

  • Administered Treatments

    units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists

    Week three of treatment: assessment of administered treatment units

  • Administered Treatments

    units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists

    Week four of treatment: assessment of administered treatment units

  • Administered Treatments

    units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists

    Week five of treatment: assessment of administered treatment units

  • Administered Treatments

    units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists

    Week six of treatment: assessment of administered treatment units

  • Administered Treatments

    units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists

    Week seven of treatment: assessment of administered treatment units

  • Administered Treatments

    units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists

    Week eight of treatment: assessment of administered treatment units

Secondary Outcomes (1)

  • HONOS - Health of the Nation Outcome Scales

    administered once per patient at week one of treatment

Study Arms (4)

Departments for Psychosomatic Medicine at University Clinics

no study interventions, observational group

Other: no intervention, purely observational

Clinics specialized in Psychosomatic Medicine

no study interventions, observational group

Other: no intervention, purely observational

Departments for Psychosomatic Medicine at general hospitals

no study interventions, observational group

Other: no intervention, purely observational

Departments for Psychosomatic Medicine at psychiatric hospitals

no study interventions, observational group

Other: no intervention, purely observational

Interventions

There will be no interventions. The study is purely observational and investigates differences in naturally occuring treatments at these four types of departments for Psychosomatic Medicine.

Clinics specialized in Psychosomatic MedicineDepartments for Psychosomatic Medicine at University ClinicsDepartments for Psychosomatic Medicine at general hospitalsDepartments for Psychosomatic Medicine at psychiatric hospitals

Eligibility Criteria

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

nationwide German population of psychosomatic specialist clinics and departments at University hospitals, general hospitals, or psychiatric hospitals

You may qualify if:

  • belong to the predefined nationwide population of psychosomatic specialist clinics and departments
  • the clinic management (head physician or comparable) agrees to participation in the study
  • possibility of electronic recording of the qualified therapy units for all treating professional groups.
  • patient treated in one of the selected clinics on the corresponding ward or day clinic
  • at least 18 years old

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simone University Jennissen

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study coordinator

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 15, 2022

Study Start

June 11, 2021

Primary Completion

May 31, 2023

Study Completion

December 31, 2023

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations