JMIR Publications

ABSTRACT

Background:

Intensive care units (ICUs) present a highly stressful environment for patients, relatives, and healthcare professionals (HCPs), often resulting in psychological distress. Despite the well-documented psychosocial burden, there is a lack of low-threshold, integrated support structures for all target groups. Based on the findings of Phase A, a complex intervention was developed involving the permanent integration of clinical psychologists into ICU teams.

Objective:

Objective This pilot study (Phase B of the IPS-Pilot project) aims to assess the feasibility of a pragmatic, cluster-randomized controlled trial (pilot RCT) to evaluate the implementation, acceptability, and potential impact of an integrated psychosocial intervention in adult ICU settings.

Methods:

A multicenter, cluster-randomized feasibility trial is conducted across eight ICUs in Germany (Ulm, Berlin, Magdeburg). The intervention group receives continuous support from study therapists (STs; clinical psychologists) embedded within the ICU team. The control group continues with usual psychosocial care (e.g., consultation-based). Mixed methods are applied: quantitative surveys at two time points (baseline and follow-up) for HCPs and relatives, and one-time follow-up for patients; qualitative interviews with STs and ICU staff after four months. Additional continuous documentation of the intervention process is conducted by STs. Data collection is pseudonymized and managed via secure, General Data Protection Regulation-compliant infrastructure.

Results:

Recruitment and baseline data collection began in July 2024. As of March 2025, 177 healthcare professionals, 82 relatives, and 72 patients have been recruited and participated in baseline assessments. Qualitative interviews were conducted with all study therapists and 22 healthcare professionals during the fourth month of the intervention. Preliminary process data suggest successful implementation of the intervention across all study sites. Final participation rates and feasibility outcomes will be analyzed and reported by mid-2025.

Conclusions:

Preliminary findings suggest that the intervention may be feasible and well accepted. The study design enables the identification of contextual barriers and facilitators, informing the development of a future effectiveness trial. Methodological triangulation ensures robust insights into real-world implementation challenges. Final results will contribute to the design of a subsequent definitive trial. Clinical Trial: Recruitment began in July 2024 and is ongoing. Study completion is anticipated for June 2025. The trial is registered on OSF (10.17605/OSF.IO/ZT5N9) and ClinicalTrials.gov (NCT06733493).