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ACTIVE NOT RECRUITING
NCT06733493
NA

Study Protocol for a Pilot Randomized Controlled Trial of a Psychosocial Care Intervention in Intensive Care

Sponsor: Harald Gündel

View on ClinicalTrials.gov

Summary

This Pilot-RCT is part of a feasibility study that aims to learn if the IPS-psychosocial care intervention and an RCT on its efficacy are feasible in patients, relatives and staff on icu wards. The Pilot-RCT will examine outcomes, that might indicate an improvement in psychosocial safety climate and other health- and wellbeing-related measures due to the administration of the intervention that is described in the following. The main question the Pilot-RCT aims to answer is: Is there evidence that the IPS intervention improves the psychosocial safety climate and other components of psychosocial well-being in ICU teams, patients and their relatives? Researchers will compare four intervention groups (icu wards with implementation of the IPS-Intervention) with four control groups (icu wards with regular supply of psychosocial care) to see if the comparison of two groups in this RCT is feasible. The IPS-Intervention consists of a ward psychologist who works as part of the ICU team and takes care of the staff, patients and relatives in accordance to the intervention manual that was developed in a prior phase of this project.

Official title: Integrated Psychosocial Care in Intensive Care: Piloting of an Innovative Care Approach (IPS Pilot) - Study Protocol for a Pilot Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

375

Start Date

2024-08-01

Completion Date

2025-07-31

Last Updated

2025-07-01

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

integrated psychosocial care

Employment of a psychologist in psychotherapeutic training as a member of the multiprofessional team at the ICU ward for the duration of one year. Tasks: Psychosocial Support for staff, patients and their relatives.

Locations (4)

Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm

Ulm, Baden-Wurttemberg, Germany

Psychosomatic Medicine and Psychosomatic Therapy, Medical Faculty University Hospital Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Institute of Social Medicine and Health Systems Research (ISMHSR)

Magdeburg, Saxony-Anhalt, Germany

Medical Clinic - Department of Psychosomatic Medicine of the Charité

Berlin, State of Berlin, Germany