NCT05780476

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

February 28, 2023

Last Update Submit

March 26, 2026

Conditions

Caregiver Burden

Keywords

Informal caregiverVirtual realityPsychoeducation intervention

Outcome Measures

Primary Outcomes (2)

  • Change in distress of care after intervention

    Zarit Burden interview - ZBI

    Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

  • Change in anxiety

    State Trait Anxiety Inventory - STAI-Y

    Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

Secondary Outcomes (3)

  • Change in empathy

    Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

  • Change in sense of competence

    Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

  • Modulation of neural activity in brain systems regulating empathy

    Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

Other Outcomes (4)

  • Persistence of medium-term effects - distress of care

    2 months post-intervention.

  • Persistence of medium-term effects - anxiety

    2 months post-intervention.

  • Persistence of medium-term effects - empathy

    2 months post-intervention.

  • +1 more other outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Psychoeducational program.

Behavioral: Psychoeducation

Experimental group

EXPERIMENTAL

Psychoeducational program combined with virtual reality.

Behavioral: Psychoeducation + virtual reality

Interventions

PsychoeducationBEHAVIORAL

6 sessions of 2 hours over 6 weeks

Control group
Psychoeducation + virtual realityBEHAVIORAL

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).

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Medical history of epilepsy.
  • Metal implants, artificial prostheses, pace-makers, prosthetic heart valves;
  • Claustrophobia;
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, Italy, 25125, Italy

Location

Related Publications (4)

  • 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.

    PMID: 32695039BACKGROUND

  • Morganti 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.

    PMID: 39335348RESULT

  • Festari 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.

    PMID: 39267224RESULT

  • Singh 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.

    PMID: 40908671DERIVED

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Cristina Festari, PhD

    IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-arm randomized controlled design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 22, 2023

Study Start

October 27, 2022

Primary Completion

February 27, 2025

Study Completion

July 31, 2025

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

IT(1)