Cognitive Model for Behavioral Interventions to reduce behavioral and psychological symptoms in people with dementia
Examining the Efficacy of a Personalized Cognitive Model as Non-Pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia
This project will try a person-centered, non-drug program called CoMBI to see if it reduces behavioral and psychological symptoms in people with dementia living in nursing homes and eases caregiver burden.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Vrije Universiteit Brussel Academic / other |
| Locations | 1 site (Tienen, Vlaams-Brabant) |
| Trial ID | NCT07356336 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are nursing home residents with a formal diagnosis of neurocognitive disorder and at least one current behavioral or psychological symptom, with a Dutch-proficient primary caregiver and an informant available to provide premorbid personality information.
Not a fit: People without current BPSD, those not residing in participating nursing homes, or those lacking a Dutch-speaking caregiver or informant are unlikely to be eligible or benefit from this program.
Why it matters
Potential benefit: If successful, CoMBI could reduce BPSD, lower caregiver burden, and improve quality of life without adding medication-related risks.
How similar studies have performed: Previous non-pharmacological, person-centered interventions have shown mixed results, with some trials reducing BPSD and caregiver burden while others found limited effects, so CoMBI builds on promising but variable prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tienen, Vlaams-Brabant
- Alexianen Zorggroep Tienen — Tienen, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Study coordinator: Jessica Vandezande
- Email: jessica.blanco.vandezande@vub.be
- Phone: +32493704603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.