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

Efficacy of a Psychosocial Intervention (Sensory and General Stimulation and Caregiver Education) in Patients With Behavioral Disturbances Associated With Dementia or Delirium Hospitalized in an Acute Care Hospital: The ESSECOA Longitudinal Study

Behavioral and psychological symptoms are common among older adults hospitalized with dementia or delirium and may include agitation, wandering, delusions, hallucinations, aggression, oppositional behavior, and sleep disturbances. These symptoms can increase the risk of falls, prolonged hospitalization, functional decline, institutionalization, and caregiver burden. Pharmacological treatment and physical restraint may be ineffective or may worsen clinical outcomes, while evidence on non-pharmacological interventions in acute hospital settings remains limited.

The ESSECOA study is a single-center, randomized, controlled, open-label trial conducted in the Geriatric Unit of the Azienda Ospedaliero-Universitaria di Modena. It evaluates whether adding a structured psychosocial intervention to standard pharmacological management is more effective than standard pharmacological management alone in reducing behavioral disturbances in hospitalized patients aged over 65 years with dementia and/or delirium.

Eligible participants are randomized to one of two parallel groups. The control group receives pharmacological management according to clinical guidelines and best practice. The intervention group receives the same pharmacological management plus sensory and general 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 stimulation sessions and receive two structured educational interventions, one during hospitalization and one before discharge, aimed at improving communication and management strategies that can also be used at home.

The primary objective is to compare the change in behavioral symptoms between groups using the Neuropsychiatric Inventory (NPI). Secondary objectives are to identify which behavioral symptoms respond best to the non-pharmacological approach, particularly in relation to caregiver education. Additional assessments include delirium, cognitive and functional status, depression, comorbidity, antipsychotic medication use, length of hospital stay, discharge destination, healthcare use, mortality, caregiver burden, perceived competence, and perceived needs.

Inclusion Criteria:

• Age older than 65 years.
• Diagnosis of dementia and/or delirium.
• Availability of a caregiver who also assists the participant at home and is willing to participate in the caregiver education program.
• Presence of behavioral disturbances, defined as a Neuropsychiatric Inventory (NPI) total score of 24 or higher, or a score of 12 in at least one NPI symptom domain.
• No clinical condition at hospital admission that would prevent delivery of the non-pharmacological intervention, including isolation for SARS-CoV-2 infection or another condition requiring isolation, deep sedation, coma, or severe respiratory failure.
• Written informed consent provided by the participant, when capable of providing consent, or by the participant's legal guardian or legally authorized representative.
• Written informed consent provided by the caregiver.

Exclusion Criteria:

• Age younger than 65 years.
• No diagnosis of dementia or delirium.
• No available caregiver, or caregiver unwilling or unable to participate in the education program.
• NPI total score lower than 24 and no individual NPI symptom domain score of 12.
• Clinical condition present at admission or developing during hospitalization that prevents delivery of the non-pharmacological intervention, including isolation for SARS-CoV-2 infection or another condition requiring isolation, deep sedation, coma, or severe respiratory failure.
• Informed consent not obtained from the participant, when capable of providing consent, or from the participant's legal guardian or legally authorized representative.
• Informed consent not obtained from the caregiver.