Actively Recruiting
Cognitive Model for Behavioral Interventions as a Non-pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia
Led by Vrije Universiteit Brussel · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
Sponsors
V
Vrije Universiteit Brussel
Lead Sponsor
A
Alexianen Zorggroep Tienen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cognitive Model for Behavioral Interventions as a Non-pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Resident in a participating nursing home
- Formal diagnosis of neurocognitive disorder (NCD) according to DSM-5-TR or medical record indicating probable dementia
- Presence of one or more behavioral and psychological symptoms of dementia (BPSD) at study start measured by NPI-Q
- Primary caregivers and patient's representative or close relative able to complete questionnaires in Dutch
- Informant completing premorbid personality questionnaire knows the patient well before dementia onset
- Informed consent obtained from resident or legal representative if resident is legally incapacitated
You will not qualify if you...
- Nursing homes already using a structured, theory-based behavioral counseling as care as usual
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Alexianen Zorggroep Tienen
Tienen, Vlaams-Brabant, Belgium, 3300
Actively Recruiting
Research Team
J
Jessica Vandezande
CONTACT
G
Gina Rossi, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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