Psychosocial Intervention for Behavioral Symptoms in Hospitalized Patients With Dementia or Delirium

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Behavioral and psychological symptoms are common among older adults hospitalized withdementia or delirium and may include agitation, wandering, delusions, hallucinations,aggression, oppositional behavior, and sleep disturbances. These symptoms can increasethe risk of falls, prolonged hospitalization, functional decline, institutionalization,and caregiver burden. Pharmacological treatment and physical restraint may be ineffectiveor may worsen clinical outcomes, while evidence on non‐pharmacological interventions inacute hospital settings remains limited.The ESSECOA study is a single‐center, randomized, controlled, open‐label trial conductedin the Geriatric Unit of the Azienda Ospedaliero‐Universitaria di Modena. It evaluateswhether adding a structured psychosocial intervention to standard pharmacologicalmanagement is more effective than standard pharmacological management alone in reducingbehavioral disturbances in hospitalized patients aged over 65 years with dementia and/ordelirium.Eligible participants are randomized to one of two parallel groups. The control groupreceives pharmacological management according to clinical guidelines and best practice.The intervention group receives the same pharmacological management plus sensory andgeneral stimulation sessions three times per week, lasting approximately 40 minutes each.The intervention is individualized according to the patient's history, preferences,target symptoms, and residual abilities. Caregivers are involved during the stimulationsessions and receive two structured educational interventions, one during hospitalizationand one before discharge, aimed at improving communication and management strategies thatcan also be used at home.The primary objective is to compare the change in behavioral symptoms between groupsusing the Neuropsychiatric Inventory (NPI). Secondary objectives are to identify whichbehavioral symptoms respond best to the non‐pharmacological approach, particularly inrelation to caregiver education. Additional assessments include delirium, cognitive andfunctional status, depression, comorbidity, antipsychotic medication use, length ofhospital stay, discharge destination, healthcare use, mortality, caregiver burden,perceived competence, and perceived needs.
Epistemonikos ID: 209620860092852b513aaecc9dd3f26309af06ee
First added on: Aug 21, 2026