A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control group Psychoeducational program. |
Behavioral: Psychoeducation
6 sessions of 2 hours over 6 weeks
|
| Experimental: Experimental group Psychoeducational program combined with virtual reality. |
Behavioral: Psychoeducation + virtual reality
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).
|
Outcome Measures
Primary Outcome Measures
- Change in distress of care after intervention [Baseline (pre-intervention); Post-intervention (up to a week post-intervention).]
Zarit Burden interview - ZBI
- Change in anxiety [Baseline (pre-intervention); Post-intervention (up to a week post-intervention).]
State Trait Anxiety Inventory - STAI-Y
Secondary Outcome Measures
- Change in empathy [Baseline (pre-intervention); Post-intervention (up to a week post-intervention).]
Interpersonal Reactivity Index - IRI
- 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
Other Outcome Measures
- Persistence of medium-term effects - distress of care [2 months post-intervention.]
Zarit Burden interview - ZBI
- Persistence of medium-term effects - anxiety [2 months post-intervention.]
State Trait Anxiety Inventory - STAI-Y
- Persistence of medium-term effects - empathy [2 months post-intervention.]
Interpersonal Reactivity Index - IRI
- Persistence of medium-term effects - sense of competence [2 months post-intervention.]
Short sense of competence questionnaire - SSCQ
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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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:
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Receiving daily assistance for more than 10 hours from formal CGs;
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Being formal CGs (i.e., nurse or another paid figure);
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Being informal CGs of i) persons with moderate-to-severe AD, or ii) persons with non-AD diseases;
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Not having or being able to use a device connected to internet (e.g., smartphones or PC).
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Having received psychotherapeutic o psychological support, or having already participated to psychoeducational programs.
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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:
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Metal implants, artificial prostheses, pace-makers, prosthetic heart valves;
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Claustrophobia;
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Pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Centro San Giovanni di Dio Fatebenefratelli | Brescia | Italy | 25125 |
Sponsors and Collaborators
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Alzheimer's Association
- University of Bergamo
Investigators
- Principal Investigator: Cristina Festari, PhD, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- AACSF-22-924470