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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Collaborators revised (3)v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 1, 2026 to Feb 16, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07356336
Lead Sponsor Vrije Universiteit Brussel
Collaborators: Alexianen Zorggroep Tienen, woonzorggroep Begralim, Mondriaan GGZ
Conditions
(from sponsor)		 Behavioral and Psychological Symptoms of Dementia
Related terms Behavior
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov