"CoMBI-SMI Multicenter Study: A Person-Centered Cognitive-Behavioral Intervention for Severe Mental Illness"
Launched by VRIJE UNIVERSITEIT BRUSSEL · May 27, 2025
Trial Information
Current as of July 01, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The "CoMBI-SMI Multicenter Study" is looking into a new approach called Cognitive Model for Behavioral Interventions for Severe Mental Illness (CoMBI-SMI). This study aims to find out if this method can help improve the lives of adults with severe mental illness by reducing challenging behaviors, like aggression or repetitive actions, and easing their psychological symptoms. It involves participants from various locations, including the Netherlands, Belgium, and the Caribbean.
To join the study, individuals must be at least 18 years old and have severe mental illness along with behavioral issues, but they should not have dementia. Participants will initially receive their regular treatment, and then, after the care teams are trained in the new approach, they will experience four weeks of CoMBI-SMI care. Throughout the study, participants will fill out questionnaires about their behaviors, symptoms, and overall quality of life. The findings could lead to better support for both patients and the caregivers who help them manage challenging behaviors.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Psychogeriatric inpatients aged 18 years and older
- • Clinical diagnosis of a severe mental illness (SMI)
- • Presence of behavioral problems not understood by caregivers
- • Willingness and ability to participate in the study
- Exclusion Criteria:
- • - Diagnosis of dementia
About Vrije Universiteit Brussel
The Vrije Universiteit Brussel (VUB) is a distinguished research university located in Brussels, Belgium, known for its commitment to innovative education and cutting-edge research across various disciplines. As a clinical trial sponsor, VUB actively engages in advancing medical knowledge and improving patient care through rigorous scientific investigations. The university fosters collaborations with healthcare institutions and industry partners, ensuring that its clinical trials adhere to the highest ethical standards and regulatory requirements. VUB's research initiatives are driven by a multidisciplinary approach, leveraging expertise from fields such as medicine, health sciences, and biomedical engineering to address pressing health challenges and contribute to the development of novel therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Heerlen, Limburg, Netherlands
Patients applied
Trial Officials
van Alphen, Prof. dr.
Principal Investigator
Mondriaan
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported