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

NCT07778329 | Active Not Recruiting

• 2 other identifiers: 1062/2020/SPER/AOUMOSIRER ID 925
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

BPSD (Behavioral and Psycological Symptoms of Dementia)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Neuropsychiatric Inventory Total Score at Hospital Discharge

  The Neuropsychiatric Inventory (NPI) assesses behavioral and psychological symptoms in participants with dementia and/or delirium. The primary outcome is the change in total NPI score from baseline to the pre-discharge assessment. The mean change will be compared between the two study arms. A between-group difference of at least 10 points is considered clinically relevant. Higher scores indicate more severe behavioral symptoms.

  Baseline and hospital discharge, up to 45 days

Secondary Outcomes (1)

• Change From Baseline in Individual Neuropsychiatric Inventory Domain Scores at Hospital Discharge

  Baseline and hospital discharge, up to 45 days

Study Arms (2)

Standard Pharmacological Management

ACTIVE COMPARATOR

Participants receive pharmacological management of behavioral disturbances according to applicable clinical guidelines and, where guidelines are unavailable, according to best clinical practice. Caregivers receive routine information about the participant's clinical condition and plan of care.

Other: Standard Pharmacological Management

Pharmacological Management Plus Psychosocial Intervention

EXPERIMENTAL

Participants receive the same standard pharmacological management as the control group plus individualized sensory and general stimulation sessions three times per week during hospitalization, lasting approximately 40 minutes each. Caregivers are involved in the stimulation sessions and receive two structured educational sessions, one during hospitalization and one before discharge.

Behavioral: Sensory and General Stimulation With Caregiver Education; Other: Standard Pharmacological Management

Interventions

Sensory and General Stimulation With Caregiver Education BEHAVIORAL

Participants receive individualized sensory and general stimulation administered by trained geriatric unit staff three times per week during hospitalization, with each session lasting approximately 40 minutes. Activities are tailored to the participant's personal history, preferences, target behavioral symptoms, and residual abilities. They may include multisensory stimulation in a Snoezelen environment and simple meaningful activities involving the senses. Caregivers participate in the stimulation sessions and receive two structured educational sessions, one during hospitalization and one before discharge, focused on communication and individualized strategies for managing behavioral symptoms at home.

Also known as: Psychosocial Intervention, Snoezelen-Based Intervention

Pharmacological Management Plus Psychosocial Intervention

Standard Pharmacological Management OTHER

Behavioral symptoms are managed according to applicable clinical guidelines and, where specific guidelines are unavailable, according to best clinical practice. Treatment is individualized by the treating physician according to the participant's target symptoms, clinical condition, and comorbidities. The protocol does not mandate a specific study drug, dose, or fixed treatment regimen. Caregivers receive routine information regarding the participant's clinical condition and plan of care.

Pharmacological Management Plus Psychosocial Intervention; Standard Pharmacological Management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

Ospedale Civile di Baggiovara

Modena, Emilia-Romagna, 41124, Italy

Location

MeSH Terms

Conditions

Behavior

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 21, 2026
• Study Start: September 1, 2021
• Primary Completion: August 6, 2026
• Study Completion: August 30, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

IT (1)