NCT07778329 · ACTIVE NOT RECRUITING
Psychosocial Intervention for Behavioral Symptoms in Hospitalized Patients With Dementia or Delirium
This trial is testing whether adding a structured psychosocial program to standard drug treatment reduces behavioral symptoms like agitation, aggression, and sleep disturbances in hospitalized dementia or delirium patients over 65. The add-on includes personalized sensory stimulation sessions and caregiver education. It is a Phase NA randomized controlled trial, meaning it is evaluating a non-drug approach in a real clinical setting rather than testing a new drug for approval.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-21