Study Protocol for a Pilot Randomized Controlled Trial of a Psychosocial Care Intervention in Intensive Care
Launched by HARALD GÜNDEL · Dec 10, 2024
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new support program called the IPS-psychosocial care intervention, which aims to improve the mental and emotional well-being of patients, their families, and ICU staff. The researchers want to see if this program can create a better atmosphere and safety for everyone involved in the care process. They will compare eight intensive care units (ICUs) that use the IPS intervention with eight that continue to provide standard care, to determine if the new approach provides any benefits.
To participate in the trial, you must be connected to one of the eight participating ICUs, either as a healthcare worker, a patient, or a family member of a patient. Unfortunately, people under 18 years old or those who cannot give permission to participate cannot join. If you are eligible, you can expect to contribute to valuable research that could lead to improvements in psychosocial support during critical care, helping not just patients but also their loved ones and healthcare providers.
Gender
ALL
Eligibility criteria
- 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
About Harald Gündel
Harald Gündel is a dedicated clinical trial sponsor focused on advancing medical research and healthcare innovation. With a commitment to ethical standards and regulatory compliance, the organization actively facilitates the design, implementation, and management of clinical trials across various therapeutic areas. Leveraging a robust network of researchers and institutions, Harald Gündel aims to enhance patient outcomes through the development of novel therapies and treatment modalities. Through meticulous oversight and a patient-centered approach, the sponsor strives to contribute significantly to the scientific community and improve global health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ulm, Baden Württemberg, Germany
Magdeburg, Sachsen Anhalt, Germany
Magdeburg, Sachsen Anhalt, Germany
Berlin, , Germany
Ulm, , Germany
Patients applied
Trial Officials
Harald Gündel, Prof. Dr. med.
Principal Investigator
Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm,
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported