BPSD (Behavioral and Psycological Symptoms of Dementia)ESSECOANCT07778329
Psychosocial Intervention for Behavioral Symptoms in Hospitalized Patients With Dementia or Delirium
A study testing Sensory and General Stimulation With Caregiver Education and Standard Pharmacological Management in people with BPSD (Behavioral and Psycological Symptoms of Dementia), run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- BPSD (Behavioral and Psycological Symptoms of Dementia)
- What is being tested?
- Sensory and General Stimulation With Caregiver Education and Standard Pharmacological Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Sensory and General Stimulation With Caregiver Education, Standard Pharmacological Management
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory and General Stimulation With Caregiver EducationBehavioural
Also called Psychosocial Intervention, Snoezelen-Based Intervention
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.
Standard Pharmacological ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sensory and General Stimulation With Caregiver Education; Other: Standard Pharmacological Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and hospital discharge, up to 45 days
Secondary outcomes (1)
Change From Baseline in Individual Neuropsychiatric Inventory Domain Scores at Hospital Discharge
Changes in individual Neuropsychiatric Inventory (NPI) symptom domain scores from baseline to the pre-discharge assessment will be compared between the two study arms to determine which behavioral symptoms show greater improvement with the addition of the psychosocial intervention. Higher scores indicate greater symptom severity.
Measured: Baseline and hospital discharge, up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2021
- Primary completion6 Aug 2026
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPSD (Behavioral and Psycological Symptoms of Dementia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Neviani, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778329
- Sponsor's protocol ID
- 1062/2020/SPER/AOUMO
- Other IDs
- SIRER ID 925
- Acronym
- ESSECOA
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07778329
- Acronym / sponsor ID
- ESSECOA / 1062/2020/SPER/AOUMO
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Pharmacological Management | Active comparator | Other: Standard Pharmacological ManagementParticipants 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. |
| Pharmacological Management Plus Psychosocial Intervention | Experimental | Behavioral: Sensory and General Stimulation With Caregiver Education, Other: Standard Pharmacological ManagementParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory and General Stimulation With Caregiver EducationAlso: Psychosocial Intervention, Snoezelen-Based InterventionParticipants 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. | Behavioural | Pharmacological Management Plus Psychosocial Intervention |
| Standard Pharmacological ManagementBehavioral 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. | Other | Pharmacological Management Plus Psychosocial Intervention, Standard Pharmacological Management |
Primary outcome
Change From Baseline in Neuropsychiatric Inventory Total Score at Hospital Discharge
Time frame: Baseline and hospital discharge, up to 45 days
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.
1 secondary outcome
Change From Baseline in Individual Neuropsychiatric Inventory Domain Scores at Hospital Discharge
Time frame: Baseline and hospital discharge, up to 45 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory and General Stimulation With Caregiver Education and Standard Pharmacological Management in people with BPSD (Behavioral and Psycological Symptoms of Dementia), run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Neuropsychiatric Inventory Total Score at Hospital Discharge (time frame: Baseline and hospital discharge, up to 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.