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Examining the Efficacy of a Personalized Cognitive Model as Non-Pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Being a resident in a participating nursing home

• Having a formal diagnosis of neurocognitive disorder (NCD) accord-ing to DSM-5-TR (e.g. Alzheimer's disease, NCD with Lewy Bodies, Vascular NCD, …) or a medical record indicating probable dementia

• Presence of one or more BPSD symptoms at moment of inclusion in the study (measured with the NPI-Q at baseline). Symptoms measured by the NPI-Q include delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria/elated mood, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, nighttime behavior disturbances/sleep disturbances, and changes in appetite and eating behavior.

• Primary caregivers (i.e. nurses providing daily care) and patient's representative and/or a close relative/friend (i.e. informant who will fill in the premorbid personality questionnaire) are proficient in Dutch (i.e., are able to fill in the questionnaires)

• The informant who fills in the premorbid personality questionnaire knows the patient well from before the onset of neurocognitive problems

• As individuals with dementia are often legally incapacitated, informed consent will be obtained prior to participation from the resident when competent to consent, or otherwise from the resident's legal representative when legally incompetent.

Locations
Other Locations
Belgium
Alexianen Zorggroep Tienen
RECRUITING
Tienen
Contact Information
Primary
Jessica Vandezande
jessica.blanco.vandezande@vub.be
+32493704603
Backup
Gina Rossi, Prof. Dr.
gina.rossi@vub.be
+32476721678
Time Frame
Start Date: 2026-02-16
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 60
Treatments
No_intervention: Care as usual
Participants receive standard care without implementation of a theory-based, behavioral counseling intervention.
Experimental: CoMBI
Related Therapeutic Areas
Sponsors
Collaborators: Mondriaan, Alexianen Zorggroep Tienen, vzw Bejaardenzorg Grauwzusters Limburg
Leads: Vrije Universiteit Brussel

This content was sourced from clinicaltrials.gov