CompletedNot Applicable

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

Italy127 participantsStarted 2022-10-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Change in distress of care after intervention

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

Change in anxiety

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

Trial details

NCT IDNCT05780476

SponsorIRCCS Centro San Giovanni di Dio Fatebenefratelli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-27