Cognitive Model for Behavioral Interventions to reduce behavioral and psychological symptoms in people with dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares CoMBI, a person-centered non-pharmacological program grounded in Beck's cognitive model and nursing interventions, to usual care for nursing home residents with dementia who have one or more behavioral or psychological symptoms. CoMBI targets unmet core needs shaped by premorbid personality and environmental triggers and is delivered through individualized caregiver-led interventions in participating facilities. Outcomes include severity of behavioral and psychological symptoms (measured with the NPI-Q), caregiver burden, and quality of life, with additional analysis of whether personality, gender, cognitive level and dementia stage modify effects. The intervention is implemented in collaborating nursing homes and requires Dutch-proficient caregivers and informants for questionnaire completion.

Why it matters

Who can join: the full rules

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.

Where it's running

• Alexianen Zorggroep Tienen
  Tienen, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Study coordinator: Jessica Vandezande
• Email: jessica.blanco.vandezande@vub.be
• Phone: +32493704603

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.