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Completed

NCT Number: NCT05780476

A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, Italy, 25125

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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.

Treatment and study plan

Psychoeducation

Behavioral

6 sessions of 2 hours over 6 weeks

Psychoeducation + virtual reality

Behavioral

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).

Primary outcomes

  1. Change in distress of care after intervention

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

    Zarit Burden interview - ZBI

  2. Change in anxiety

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

    State Trait Anxiety Inventory - STAI-Y

Secondary outcomes

  1. Change in empathy

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

    Interpersonal Reactivity Index - IRI

  2. Change in sense of competence

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

    Short sense of competence questionnaire - SSCQ

  3. Modulation of neural activity in brain systems regulating empathy

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

    Task fMRI

Other outcomes

  1. Persistence of medium-term effects - distress of care

    Time frame: 2 months post-intervention.

    Zarit Burden interview - ZBI

  2. Persistence of medium-term effects - anxiety

    Time frame: 2 months post-intervention.

    State Trait Anxiety Inventory - STAI-Y

  3. Persistence of medium-term effects - empathy

    Time frame: 2 months post-intervention.

    Interpersonal Reactivity Index - IRI

  4. Persistence of medium-term effects - sense of competence

    Time frame: 2 months post-intervention.

    Short sense of competence questionnaire - SSCQ

Sponsors and collaborators

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Other

Collaborators

  • Alzheimer's Association
  • University of Bergamo

Registry information

Official study title

A Novel Virtual Reality Intervention for Caregivers of People With Dementia.

Acronym: VirtualCare

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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