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.

Background: Intensive care units (ICUs) present a highly stressful environment for patients, relatives, and health care professionals, 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 study therapists into ICU teams. Objective: This pilot study (phase B of the Integrated Psychosocial Care [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 8 ICUs in Germany (Ulm, Berlin, and Magdeburg). The intervention group received continuous support from study therapists embedded within the ICU team. The control group continues with usual psychosocial care (eg, consultation-based). Mixed methods are applied: quantitative surveys at 2 time points (baseline and follow-up) for health care professionals and relatives, and 1-time follow-up for patients; qualitative interviews with study therapists and health care professionals after 4 months. Additional continuous documentation of the intervention process is conducted by study therapists. Data collection was pseudonymized and managed via secure, General Data Protection Regulation-compliant infrastructure. Results: Funding for the IPS-Pilot project was awarded in January 2023. Recruitment and baseline data collection for phase B began in July 2024 and were ongoing at the time of manuscript submission (May 2025). By March 2025, 177 health care professionals and 82 relatives had completed baseline questionnaires. In addition, all planned qualitative process interviews with all 4 study therapists and 22 health care professionals were conducted in month 4 of the intervention. Data collection took place through June 2025. The initial study results are scheduled to be published in 2026, following the completion of data analysis. 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.