Cognitive Model for Behavioral Interventions as a Non-pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia

The goal of this study is to evaluate whether the Cognitive Model for Behavioral Interventions (CoMBI), a person-centered, non-pharmacological intervention, can reduce behavioral and psychological symptoms of dementia (BPSD) in people with dementia living in nursing homes. The study also aims to examine whether CoMBI can reduce caregiver burden and improve quality of life in people with dementia. The main questions it aims to answer are: Does CoMBI reduce the severity of behavioral and psychological symptoms of dementia compared to care as usual? Does a reduction in BPSD lead to lower caregiver burden and improved quality of life for people with dementia? Do personal factors, such as personality (dys)functioning, gender, level of cognitive impairment and stage of dementia, influence the effectiveness of CoMBI? Researchers will compare CoMBI to care as usual to determine whether CoMBI leads to better outcomes for people with dementia and their caregivers. Participants will: Receive care in residential long-term care facilities where care staff are trained to apply CoMBI. Be observed and assessed repeatedly over time as part of a stepped-wedge cluster randomized trial design.

NCT Number	NCT07356336
Lead Sponsor	Vrije Universiteit Brussel Collaborators: Alexianen Zorggroep Tienen, vzw Bejaardenzorg Grauwzusters Limburg, Mondriaan
Conditions	Behavioral and Psychological Symptoms of Dementia
Enrollment	60 participants
Start Date	2026-02-16
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-11