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

Not Applicable

Recruiting

• Conditions: Caregiver Burden

• Registration Number: NCT05780476
• Lead Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-27
• Study First Submitted: 2023-02-28
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-22
• Last Update Posted: 2023-03-22
• Primary Completion: 2024-12-30
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in anxiety	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).	State Trait Anxiety Inventory - STAI-Y
Change in distress of care after intervention	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).	Zarit Burden interview - ZBI

Secondary Outcome Measures

Name	Time	Method
Change in sense of competence	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).	Short sense of competence questionnaire - SSCQ
Modulation of neural activity in brain systems regulating empathy	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).	Task fMRI
Change in empathy	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).	Interpersonal Reactivity Index - IRI

Trial Locations

Locations (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli; 🇮🇹 Brescia, Italy