NCT07356336 Cognitive Model for Behavioral Interventions as a Non-pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia
| NCT ID | NCT07356336 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vrije Universiteit Brussel |
| Condition | Behavioral and Psychological Symptoms of Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-02-16 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07356336 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Behavioral and Psychological Symptoms of Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07356336 currently recruiting?
Yes, NCT07356336 is actively recruiting participants. Contact the research team at jessica.blanco.vandezande@vub.be for enrollment information.
Where is the NCT07356336 trial being conducted?
This trial is being conducted at Tienen, Belgium.
Who is sponsoring the NCT07356336 clinical trial?
NCT07356336 is sponsored by Vrije Universiteit Brussel. The trial plans to enroll 60 participants.