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

NCT06733493 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2025-07-01

No results posted yet for this study

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.

Conditions

  • Psychosocial Intervention
  • Intensive Care Units (ICUs)
  • Psychosocial Health

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.

Sponsors & Collaborators

  • Institute of Social Medicine and Health Systems Research, University Hospital Magdeburg

    collaborator UNKNOWN

  • University Hospital Berlin Charite

    collaborator UNKNOWN

  • Magdeburg University Hospital, Germany

    collaborator UNKNOWN

  • Harald Gündel

    lead OTHER

Principal Investigators

  • Harald Gündel, Prof. Dr. med. · Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06733493 on ClinicalTrials.gov