NCT07356336 · RECRUITING
Cognitive Model for Behavioral Interventions as a Non-pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia
This trial tests CoMBI, a person-centered behavioral approach, to see whether training nursing home staff to use it reduces agitation, anxiety, depression, and other difficult behavioral symptoms in people already living with dementia. It also measures whether it eases caregiver burden and improves residents' quality of life. This is a Phase NA trial, meaning it is evaluating a care practice rather than a drug — no approval process is involved.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: Exclusion criterion for nursing homes is: - Already applying a structured (theory-based) behavioral counseling as CAU.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-11