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

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT06733493

Acronym / sponsor ID

IPS-Pilot / 01VSF22020

Conditions

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

Keywords

health services research, psychosocial intervention, health personnel, INTENSIVE CARE UNIT, Critical Care

Study type

Interventional

Recruitment status

Active, not recruiting

Enrolment

375 participants (estimated)

Lead sponsor

Harald GündelUniversity, hospital or other

Collaborators

Institute of Social Medicine and Health Systems Research, University Hospital Magdeburg, University Hospital Berlin Charite, Magdeburg University Hospital, Germany

Study start

1 Aug 2024 (actual)

Primary completion

31 Jul 2025 (estimated)

Study completion

31 Jul 2025 (estimated)

First posted

13 Dec 2024 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (participant)

Number of arms

2

Model description

Multi-center study on 3 sites and 8 ICU wards, with cluster-randomization of intervention (n=4) and control wards (n=4). Data-collection in a mixed design: * Between-subject factor: Affiliation to intervention or control ICU ward * Between-subject factor: Affiliation to the group of healthcare professionals, relatives or patients * Within-subject factor: Time of data collection (baseline or follow-up) * Healthcare professionals: baseline (first 6 weeks of treatment) and follow-up (last 6 weeks of treatment) * Relatives: baseline (during treatment of their patient in the ICU and up to 4 weeks after), follow-up (4 months after completing baseline) * Patients: No baseline data-collection since this would produce a biased sample (only mildly impaired ICU patients), follow-up (4 months after ICU stay)

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Psychosocial Safety Climate

   Time frame: 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

2. Intention to leave

   Time frame: 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.

3. Perceived Wellbeing

   Time frame: 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.

4. Health-related quality of life

   Time frame: 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.

5. Perceived Stress

   Time frame: 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.

6. Depression / Anxiety

   Time frame: 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.

7. Work-related consequences of strain

   Time frame: 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.

8. Self-efficacy, optimism and pessimism

   Time frame: 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.

9. Team cohesion at work

   Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
• Background: PubMed 40479723Nickel SF, Korger S, Schindler W, Heytens H, Krieg G, Drewitz KP, Schurmann K, Schossow L, Gehrig J, Binnebose M, Hirning C, Honig K, Niessen RK, Kirschbaum J, Erdur L, Peter S, Junne F, Rose M, Apfelbacher C, Gundel H. Integrated Psychosocial Care in Intensive Care (IPS-Pilot): Protocol for the Systematic, Multimethod Development of a Complex Intervention (Phase A). JMIR Res Protoc. 2025 Jun 6;14:e65682. doi: 10.2196/65682.
• Derived from this study: PubMed 42224383Heytens H, Korger S, Nickel SF, Schindler W, Elgner M, Sahin KA, Krieg G, Schurmann K, Gehrig J, Brenner L, Binnebose M, Rose M, Gundel H, Junne F, Apfelbacher C. Piloting a Pragmatic Randomized Controlled Trial on the Effects of Integrated Psychosocial Care in Intensive Care Units (Phase B of the Integrated Psychosocial Care-Pilot Project): Protocol for a Feasibility Study. JMIR Res Protoc. 2026 Jun 1;15:e77490. doi: 10.2196/77490.
• Registry of the study with the funderLink provided by the sponsor.
• Project Registry at OSFLink provided by the sponsor.
• Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

4 sites in 1 country: see every site and its status.