Caregiver BurdenVirtualCareNCT05780476
A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)
A study testing Psychoeducation and Psychoeducation + virtual reality in people with Caregiver Burden, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial summary
This clinical trial aims to explore if a virtual reality experience increases the beneficial effect of psychoeducational programs in informal caregivers of people with mild-to-moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Psychoeducation and Psychoeducation + virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteItaly
- Study dates
- 27 Oct 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being an unpaid informal caregiver (CG; i.e., family members or friends) living with or caring for a person with Alzheimer's Disease (AD) for at least 4 hours a day for at least six months before enrolment;
- Caring for a person with a diagnosis of AD at prodromal or mild stage (i.e., Mini-Mental State Examination score:18-24) and still living at home.
Who cannot join
- Receiving daily assistance for more than 10 hours from formal CGs;
- Being formal CGs (i.e., nurse or another paid figure);
- Being informal CGs of i) persons with moderate-to-severe AD, or ii) persons with non-AD diseases;
- Not having or being able to use a device connected to internet (e.g., smartphones or PC).
- Having received psychotherapeutic o psychological support, or having already participated to psychoeducational programs.
- Only a family member for person with dementia is accepted.
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- Exclusion Criteria for experimental group (Psychoeducation + VR):
- Medical history of epilepsy.
- Exclusion Criteria for subsample of caregivers assess with MRI:
- Metal implants, artificial prostheses, pace-makers, prosthetic heart valves;
- Claustrophobia;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125
About this study
Official title: A Novel Virtual Reality Intervention for Caregivers of People With Dementia.
This clinical trial aims to explore if a virtual reality experience increases the beneficial effect of psychoeducational programs in informal caregivers of people with mild-to-moderate Alzheimer's disease. This study will test changes in psychological distress and neural activity in brain systems that regulate stress and empathic care.
Participants will be randomized into two arms: the control group will participate in an online psychoeducational intervention, while the experimental group will participate in the psychoeducational intervention combined with virtual reality.
- Conditions
- Caregiver Burden
- Being tested
- Psychoeducation, Psychoeducation + virtual reality
- Keywords
- Informal caregiver, Virtual reality, Psychoeducation intervention
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
6 sessions of 2 hours over 6 weeks
Psychoeducation + virtual realityBehavioural
6 sessions of 2 hours over 6 weeks. Virtual reality experience will be carry out in the last 30 minutes of each meeting. Virtual reality consists of 360-degree videos depicting everyday situations and allowing the caregivers to feel the specific symptoms of dementia (e.g., disorientation, agnosia, apraxia and memory loss).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Psychoeducational program. Receives: Behavioral: Psychoeducation |
| Experimental group | Experimental | Psychoeducational program combined with virtual reality. Receives: Behavioral: Psychoeducation + virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distress of care after intervention
Zarit Burden interview - ZBI
Measured: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Change in anxiety
State Trait Anxiety Inventory - STAI-Y
Measured: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Secondary outcomes (3)
Change in empathy
Interpersonal Reactivity Index - IRI
Measured: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Change in sense of competence
Short sense of competence questionnaire - SSCQ
Measured: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Modulation of neural activity in brain systems regulating empathy
Task fMRI
Measured: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start27 Oct 2022
- Primary completion27 Feb 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association, University of Bergamo
- Responsible party
- Principal investigator, Cristina Festari, PhD, IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Cristina Festari, PhD, Principal investigator, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780476
- Sponsor's protocol ID
- AACSF-22-924470
- Acronym
- VirtualCare
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Morganti F, Palena N, Savoldelli P, Greco A. Take the First-Person Perspective to Become Dementia-Friendly: The Use of 360 degrees Video for Experiencing Everyday-Life Challenges With Cognitive Decline. Front Psychol. 2020 Jun 30;11:1117. doi: 10.3389/fpsyg.2020.01117. eCollection 2020.
PubMed 32695039Morganti F, Gattuso M, Singh Solorzano C, Bonomini C, Rosini S, Ferrari C, Pievani M, Festari C. Virtual Reality-Based Psychoeducation for Dementia Caregivers: The Link between Caregivers' Characteristics and Their Sense of Presence. Brain Sci. 2024 Aug 23;14(9):852. doi: 10.3390/brainsci14090852.
PubMed 39335348Festari C, Bonomini C, Rosini S, Gattuso M, Singh Solorzano C, Zanetti O, Corbo D, Agnelli G, Quattrini G, Ferrari C, Gasparotti R, Pievani M, Morganti F. Virtual Reality Combined With Psychoeducation to Improve Emotional Well-Being in Informal Caregivers of Alzheimer's Disease Patients: Rationale and Study Design of a Randomized Controlled Trial. Int J Geriatr Psychiatry. 2024 Sep;39(9):e6145. doi: 10.1002/gps.6145.
PubMed 39267224Singh Solorzano C, Bonomini C, Rosini S, Passeggia I, Zanetti O, Pievani M, Frisoni GB, Festari C. The psychological impact of the disclosure of the diagnosis of Alzheimer's disease on informal caregivers. Alzheimers Dement. 2025 Sep;21(9):e70412. doi: 10.1002/alz.70412.
PubMed 40908671
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Virtual Reality Intervention for Caregivers of People With Dementia.
- ClinicalTrials.gov ID
- NCT05780476
- Acronym / sponsor ID
- VirtualCare / AACSF-22-924470
- Conditions
- Caregiver Burden
- Keywords
- Informal caregiver, Virtual reality, Psychoeducation intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Collaborators
- Alzheimer's Association, University of Bergamo
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 22 Mar 2023 (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.
This clinical trial aims to explore if a virtual reality experience increases the beneficial effect of psychoeducational programs in informal caregivers of people with mild-to-moderate Alzheimer's disease. This study will test changes in psychological distress and neural activity in brain systems that regulate stress and empathic care.
Participants will be randomized into two arms: the control group will participate in an online psychoeducational intervention, while the experimental group will participate in the psychoeducational intervention combined with virtual reality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: PsychoeducationPsychoeducational program. |
| Experimental group | Experimental | Behavioral: Psychoeducation + virtual realityPsychoeducational program combined with virtual reality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being an unpaid informal caregiver (CG; i.e., family members or friends) living with or caring for a person with Alzheimer's Disease (AD) for at least 4 hours a day for at least six months before enrolment;
- Caring for a person with a diagnosis of AD at prodromal or mild stage (i.e., Mini-Mental State Examination score:18-24) and still living at home.
Key exclusion criteria (12 listed)
- Receiving daily assistance for more than 10 hours from formal CGs;
- Being formal CGs (i.e., nurse or another paid figure);
- Being informal CGs of i) persons with moderate-to-severe AD, or ii) persons with non-AD diseases;
- Not having or being able to use a device connected to internet (e.g., smartphones or PC).
- Having received psychotherapeutic o psychological support, or having already participated to psychoeducational programs.
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 |
|---|---|---|
| Psychoeducation6 sessions of 2 hours over 6 weeks | Behavioural | Control group |
| Psychoeducation + virtual reality6 sessions of 2 hours over 6 weeks. Virtual reality experience will be carry out in the last 30 minutes of each meeting. Virtual reality consists of 360-degree videos depicting everyday situations and allowing the caregivers to feel the specific symptoms of dementia (e.g., disorientation, agnosia, apraxia and memory loss). | Behavioural | Experimental group |
Primary outcome
Change in distress of care after intervention
Time frame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Zarit Burden interview - ZBI
Change in anxiety
Time frame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
State Trait Anxiety Inventory - STAI-Y
3 secondary outcomes
Change in empathy
Time frame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Change in sense of competence
Time frame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Modulation of neural activity in brain systems regulating empathy
Time frame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 32695039Morganti F, Palena N, Savoldelli P, Greco A. Take the First-Person Perspective to Become Dementia-Friendly: The Use of 360 degrees Video for Experiencing Everyday-Life Challenges With Cognitive Decline. Front Psychol. 2020 Jun 30;11:1117. doi: 10.3389/fpsyg.2020.01117. eCollection 2020.
- Results publication: PubMed 39335348Morganti F, Gattuso M, Singh Solorzano C, Bonomini C, Rosini S, Ferrari C, Pievani M, Festari C. Virtual Reality-Based Psychoeducation for Dementia Caregivers: The Link between Caregivers' Characteristics and Their Sense of Presence. Brain Sci. 2024 Aug 23;14(9):852. doi: 10.3390/brainsci14090852.
- Results publication: PubMed 39267224Festari C, Bonomini C, Rosini S, Gattuso M, Singh Solorzano C, Zanetti O, Corbo D, Agnelli G, Quattrini G, Ferrari C, Gasparotti R, Pievani M, Morganti F. Virtual Reality Combined With Psychoeducation to Improve Emotional Well-Being in Informal Caregivers of Alzheimer's Disease Patients: Rationale and Study Design of a Randomized Controlled Trial. Int J Geriatr Psychiatry. 2024 Sep;39(9):e6145. doi: 10.1002/gps.6145.
- Derived from this study: PubMed 40908671Singh Solorzano C, Bonomini C, Rosini S, Passeggia I, Zanetti O, Pievani M, Frisoni GB, Festari C. The psychological impact of the disclosure of the diagnosis of Alzheimer's disease on informal caregivers. Alzheimers Dement. 2025 Sep;21(9):e70412. doi: 10.1002/alz.70412.
- Individual participant dataSharing planned: Undecided
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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.
Cristina Festari, PhD principal investigator
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation and Psychoeducation + virtual reality in people with Caregiver Burden, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 1 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in distress of care after intervention (time frame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05780476, which also lists 4 linked publications.
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 1 Apr 2026.