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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVrije Universiteit Brussel

About this trial

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

Qualifiers

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)

Disqualifiers

None

Trial design

Treatments tested in this trial

  • CoMBI

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Vrije Universiteit Brussel

Lead sponsor

Alexianen Zorggroep Tienen

Collaborator

vzw Bejaardenzorg Grauwzusters Limburg

Collaborator

Mondriaan

Collaborator