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

NCT07356336 | Recruiting

• 1 other identifier: 25398_CoMBI_BPSD_WZC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Behavioral and Psychological Symptoms of Dementia

Outcome Measures

Primary Outcomes (2)

• Neuropsychiatric Inventory - Questionnaire (NPI-Q)

  The Neuropsychiatric Inventory - Questionnaire (NPI-Q) (de Jonghe et al., 2003; Kaufer et al., 2000) is a validated informant evaluation of BPSD measuring severity (rating 0-3) and caregiver distress (0-5) of 12 BPSD domains (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturb-ance, nighttime behaviors, appetite/eating).

  Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.

• Qualidem

  The Qualidem (Ettema et al., 2007) is a forty-item validated behavior observation-scale for patients (i.e. nursing homes) with up to severe dementia and can be administered in 15 minutes. Nine sub-scales (care relationship, positive affect, negative affect, restless tense behavior, positive self-image, social relations, social isolation, feeling at home, having something to do) provide a QoL-profile that can be used to evaluate the effects of intervention.

  Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.

Secondary Outcomes (3)

• Montreal Cognitive Assessment (MoCA)

  Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.

• the Global Deterioration Scale

  Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.

• the Level of Personality Functioning-scale brief form 2.0 informant version (LPFS-BF 2.0)

  Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.

Study Arms (2)

Care as usual

NO INTERVENTION

Participants receive standard care without implementation of a theory-based, behavioral counseling intervention.

CoMBI

EXPERIMENTAL

Behavioral: CoMBI

Interventions

CoMBI BEHAVIORAL

CoMBI describes a four-step approach. First, the primary caregiver systematically observes and assesses the resident's BPSD using the NPI-Q. Second, the person's core needs are identified. An informant completes the PID-5-BF+M. The results of the PID-5-BF+M together with the overview of the different personality types, help identify the resident's core needs. Third, the care team selects one core need based on the most prominent and challenging BPSD. They choose a maximum of three interventions, which can focus on the substantive contact, attitude and environment of the resident. Finally, The selected interventions are further specified and personalized so that they are appropriate for the person with dementia, taking into account their life history This is documented in a CoMBI care plan, specifying which interventions will be applied and the desired behavioral outcomes.

CoMBI

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• \- Already applying a structured (theory-based) behavioral counseling as CAU.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Alexianen Zorggroep Tienen: collaborator
• vzw Bejaardenzorg Grauwzusters Limburg: collaborator
• Mondriaan: collaborator

Study Sites (1)

Alexianen Zorggroep Tienen

Tienen, Vlaams-Brabant, 3300, Belgium

RECRUITING

MeSH Terms

Conditions

Behavior

Central Study Contacts

Jessica Vandezande

CONTACT

+32493704603; jessica.blanco.vandezande@vub.be

Gina Rossi, Prof. Dr.

CONTACT

+32476721678; gina.rossi@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)