Behavioral and Psychological Symptoms of DementiaNCT07356336
Cognitive Model for Behavioral Interventions as a Non-pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia
A study testing CoMBI in people with Behavioral and Psychological Symptoms of Dementia, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Behavioral and Psychological Symptoms of Dementia
- What is being tested?
- CoMBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Feb 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Already applying a structured (theory-based) behavioral counseling as CAU.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Alexianen Zorggroep Tienen
Tienen, Vlaams-Brabant, 3300
Eva Dierckx, Prof. Dr., +322629 36 22, eva.dierckx@vub.be
About this study
Official title: Examining the Efficacy of a Personalized Cognitive Model as Non-Pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia
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:
Read more
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.
Read the detailed description
Behavioral and Psychological Symptoms of Dementia (BPSD), also referred to as neuropsychiatric symptoms, are highly prevalent across all types of dementia and represent a major clinical and societal challenge. These symptoms are associated with accelerated disease progression, reduced quality of life for people with dementia, and substantial burden for both formal and informal caregivers. In residential long-term care facilities, where BPSD are particularly common, management often relies heavily on psychotropic medication despite risks, including increased morbidity and mortality. International guidelines therefore recommend person-centered, non-pharmacological interventions as first-line treatment. However, existing non-pharmacological approaches show mixed effects, face implementation barriers, and often insufficiently account for individual differences such as premorbid personality, despite growing evidence that personality plays a key role in the development and severity of BPSD.
The Cognitive Model for Behavioral Interventions (CoMBI) is a person-centered, non-pharmacological intervention designed to address these limitations. CoMBI is grounded in the assumption that BPSD partly emerge when underlying core needs are insufficiently met. These core needs are shaped by premorbid personality characteristics and are activated by specific environmental triggers. Drawing on Beck's cognitive model of personality disorders and nursing interventions from the Nursing Intervention Classification, CoMBI distinguishes distinct personality profiles, each associated with characteristic unmet needs and triggering situations. For each profile, tailored intervention strategies have been developed to compensate for unmet needs by modifying environmental factors and caregiver responses.
The CoMBI training provides caregivers with a structured framework to understand BPSD in relation to premorbid personality and unmet core needs. Care staff are trained to assess BPSD, identify personality-related core needs and triggering events, and implement tailored interventions. This is well documented in a CoMBI care plan, specifying which interventions will be applied and the desired behavioral outcomes. The care plan can be reevaluated every care team meeting.
To empirically demonstrate the effectiveness of CoMBI, we will conduct a stepped-wedge cluster randomized trial (SW-CRT) with repeated measures. All units of the participating nursing homes will initially receive care as usual (CAU) and will sequentially transition to the CoMBI condition. Outcome measurements will be conducted every four weeks, including at the time each unit changes from CAU to CoMBI. Outcomes are assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q), the Global Deterioration Scale (GDS), Qualidem and the Montreal Cognitive Assessment (MoCA). To properly identify the core needs for CoMBI, two personality questionnaires will be administered, namely the Personality Inventory for DSM-5 Brief Form + Modified (PID-5-BF+M) and the Level of Personality Functioning Scale Brief Form 2.0 (LPFS-BF 2.0).
- Being tested
- CoMBI
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoMBIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | No intervention | Participants receive standard care without implementation of a theory-based, behavioral counseling intervention. |
| CoMBI | Experimental | Not described Receives: Behavioral: CoMBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.
Secondary outcomes (3)
Montreal Cognitive Assessment (MoCA)
The MoCA is a brief (10-15 minute) 30-point cognitive screening instrument which has been prov-en useful in identifying cognitive symptoms associated with dementia.
Measured: Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.
the Global Deterioration Scale
The GDS, describes clinical characteristics (e.g., memory, sleep, social impairment) for stages of cognitive function for those suffering from a primary degenerative dementia. Primary caregivers estimate the level of where an individual is in the disease process by observing that individual's behavioral characteristics and comparing them to the GDS stage descriptions.
Measured: 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)
Higher total scores indicate higher dysfunctioning.
Measured: Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start16 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral and Psychological Symptoms of DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Alexianen Zorggroep Tienen, woonzorggroep Begralim, Mondriaan GGZ
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356336
- Sponsor's protocol ID
- 25398_CoMBI_BPSD_WZC
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a Personalized Cognitive Model as Non-Pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia
- ClinicalTrials.gov ID
- NCT07356336
- Acronym / sponsor ID
- 25398_CoMBI_BPSD_WZC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Alexianen Zorggroep Tienen, woonzorggroep Begralim, Mondriaan GGZ
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Behavioral and Psychological Symptoms of Dementia (BPSD), also referred to as neuropsychiatric symptoms, are highly prevalent across all types of dementia and represent a major clinical and societal challenge. These symptoms are associated with accelerated disease progression, reduced quality of life for people with dementia, and substantial burden for both formal and informal caregivers. In residential long-term care facilities, where BPSD are particularly common, management often relies heavily on psychotropic medication despite risks, including increased morbidity and mortality. International guidelines therefore recommend person-centered, non-pharmacological interventions as first-line treatment. However, existing non-pharmacological approaches show mixed effects, face implementation barriers, and often insufficiently account for individual differences such as premorbid personality, despite growing evidence that personality plays a key role in the development and severity of BPSD.
The Cognitive Model for Behavioral Interventions (CoMBI) is a person-centered, non-pharmacological intervention designed to address these limitations. CoMBI is grounded in the assumption that BPSD partly emerge when underlying core needs are insufficiently met. These core needs are shaped by premorbid personality characteristics and are activated by specific environmental triggers. Drawing on Beck's cognitive model of personality disorders and nursing interventions from the Nursing Intervention Classification, CoMBI distinguishes distinct personality profiles, each associated with characteristic unmet needs and triggering situations. For each profile, tailored intervention strategies have been developed to compensate for unmet needs by modifying environmental factors and caregiver responses.
The CoMBI training provides caregivers with a structured framework to understand BPSD in relation to premorbid personality and unmet core needs. Care staff are trained to assess BPSD, identify personality-related core needs and triggering events, and implement tailored interventions. This is well documented in a CoMBI care plan, specifying which interventions will be applied and the desired behavioral outcomes. The care plan can be reevaluated every care team meeting.
To empirically demonstrate the effectiveness of CoMBI, we will conduct a stepped-wedge cluster randomized trial (SW-CRT) with repeated measures. All units of the participating nursing homes will initially receive care as usual (CAU) and will sequentially transition to the CoMBI condition. Outcome measurements will be conducted every four weeks, including at the time each unit changes from CAU to CoMBI. Outcomes are assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q), the Global Deterioration Scale (GDS), Qualidem and the Montreal Cognitive Assessment (MoCA). To properly identify the core needs for CoMBI, two personality questionnaires will be administered, namely the Personality Inventory for DSM-5 Brief Form + Modified (PID-5-BF+M) and the Level of Personality Functioning Scale Brief Form 2.0 (LPFS-BF 2.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as usual | No intervention | –Participants receive standard care without implementation of a theory-based, behavioral counseling intervention. |
| CoMBI | Experimental | Behavioral: CoMBI |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Already applying a structured (theory-based) behavioral counseling as CAU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoMBICoMBI 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. | Behavioural | CoMBI |
Primary outcome
Neuropsychiatric Inventory - Questionnaire (NPI-Q)
Time frame: Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.
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).
Qualidem
Time frame: Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.
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.
3 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.
the Global Deterioration Scale
Time frame: 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)
Time frame: Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoMBI in people with Behavioral and Psychological Symptoms of Dementia, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Vandezande (+32493704603, jessica.blanco.vandezande@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Inventory - Questionnaire (NPI-Q) (time frame: Before the start of CAU, before the start of CoMBI and after four weeks of CoMBI training.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.