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

Not Applicable

Active, not recruiting

• Conditions: Psychosocial Intervention; Intensive Care Units (ICUs); Psychosocial Health

• Registration Number: NCT06733493
• Lead Sponsor: Harald Gündel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• Affiliation to one of the 8 participating ICU wards during the duration of the study, either by: occupation as a healthcare professional, admission as a patient, relation to an admitted patient

Exclusion Criteria

• Age under 18 years old
• Inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-efficacy, optimism and pessimism	Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay	Healthcare professionals', patients', and relatives' perceived self-efficacy, optimism and pessimism measured with the german self-efficacy, optimism and pessimism questionnaire (SWOP-K9, Scholler, Fliege, \& Klapp, 1999). 9 items rated on a 4-point scale from 1 (Does not apply at all) to 4 (Applies completely) and are divided into the subscales self-efficacy, optimism and pessimism. Higher subscale means (Min=1, Max=4) for self-efficacy and optimism indicate better psychological resources; higher pessimism subscale means indicate worse outcomes.
Team cohesion at work	Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)	Team cohesion in the ICU as perceived by ICU staff in the experimental and control group, measured with the Erlangen Team Cohesion at work scale (ETC, Lieb, Erim, \& Morawa, 2024). 13 items rated on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree) and can be divided into the subsales Collegial Solidarity and Unity and Problem Management. A higher overall sum score (Min=13, Max=65) or higher subscale means (Min=1, Max=5) indicate stronger team cohesion.
Psychosocial Safety Climate	Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)	Psychosocial Safety Climate as perceived by ICU staff in the experimental and control group, measured with the German version of the Psychosocial Safety Climate (PSC-4) scale (Formazin, Ertel, Kersten, \& Nübling, 2022). 4 items (eg. "Senior management shows support for stress prevention through involvement and commitment") ranked on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). A higher sum score of the 4 items (Min = 4, Max = 20) indicates a more positive psychosocial safety climate
Intention to leave	Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)	Healthcare Professionals' Intention to leave their workplace, profession or reduce their working time, measured with the questions from the Nurses Early Exit (NEXT) study (Simon, Tackenberg, Hasselhorn, Kümmerling, Büscher, \& Müller, 2005). 3 items ranked on a 5-point Likert-scale. A higher sum score (Min=3, Max=15) indicates a higher turnover intention.
Perceived Wellbeing	Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay	Healthcare professionals', patients', and relatives' perceived well-being, measured with the german version of the WHO-5 (World Health Organization-Five) wellbeing index (Brähler, Mühlan, Albani, \& Schmidt, 2005). 5 items rated on a 6-point Likert scale ranging from 0 (At no time) to 5 (All of the time). Higher overall sumscores (Min=0, Max=25) indicate better well-being.
Health-related quality of life	Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay	Healthcare professionals', patients', and relatives' perceived health-related quality of life, measured with the german version of the Short-Form Health-Related Survey (SF-12, Drixler, Morfeld, Glaesmer, Brähler, Wirtz, 2020). 12 items with a mixed response format (2-6 options) that can be assigned to the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS and MCS are standardized (Mean = 50, SD = 10). Higher scores indicate better physical or mental health-related quality of life.
Perceived Stress	Healthcare Professionals: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment); Relatives: Baseline (during first 8 months of treatment, individually: during or up to 4 weeks after ICU admission), Follow-Up: 4 months after Base	Healthcare professionals', patients' and relatives' perception of stress, measured with the german version of the Perceived Stress Scale (PSS-10, Klein, Brähler, Dreier, Reinecke, Müller, Schmutzer, Wölfling, \& Beutel, 2016). 10 items that are rated on a 5-point Likert scale from 0 (Never) to 4 (Very often). Higher total scores (Min=0, Max=40) reflect higher perceived stress.
Depression / Anxiety	Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay	Healthcare professionals', patients', and relatives' perceived depressive and anxiety symptoms, measured with the german version of the patient health questionnaire (PHQ-4, Löwe, 2015). 4 items rated on a 4-point Likert scale from 0 (Not at all) to 3 (Nearly every day). Higher total scores (Min=0, Max=12) indicate more severe psychological distress.
Work-related consequences of strain	Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)	Emotional and cognitive irritation as perceived by ICU staff in the experimental and control group, measured with the irritation scale to measure consequencey of work-related strain (Mohr, Rigotti, \& Müller, 2007). 8 items rated on a 7-point Likert scale from 1 (Strongly disagree) to 7 (Strongly agree). Higher total scores for the overall irritation scale (Min=8, Max=56), Emotional Irritation subscale (5 items, Min=5, Max=35) and Cognitive Irritation (3 items, Min=3, Max=21) indicate higher levels of irritation.

Trial Locations

Locations (4)

Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

Psychosomatic Medicine and Psychosomatic Therapy, Medical Faculty University Hospital Magdeburg; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Institute of Social Medicine and Health Systems Research (ISMHSR); 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Medical Clinic - Department of Psychosomatic Medicine of the Charité; 🇩🇪 Berlin, Germany