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

Study Overview
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Brief Summary
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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.

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

Conditions
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Caregiver Burden

Intervention / Treatment
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* Behavioral: Psychoeducation
* Behavioral: Psychoeducation + virtual reality


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm randomized controlled design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Psychoeducational program. | Behavioral: Psychoeducation<br>* 6 sessions of 2 hours over 6 weeks<br>|
| Experimental: Experimental group<br>Psychoeducational program combined with virtual reality. | Behavioral: Psychoeducation + virtual reality<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Informal caregiver, Virtual reality, Psychoeducation intervention