NCT06733493

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Harald Gündel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2024-12-13
• Last updated: 2025-07-01

Locations

4 sites across 1 country: Germany