A Novel Virtual Reality Intervention for Caregivers of People With Dementia.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Caregiver Burden
- Sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in anxiety
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Cristina Festari, PhD
Researcher
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Change in anxiety
Time Frame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
State Trait Anxiety Inventory - STAI-Y
Change in distress of care after intervention
Time Frame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Zarit Burden interview - ZBI
Secondary Outcomes
- Change in sense of competence(Baseline (pre-intervention); Post-intervention (up to a week post-intervention).)
- Modulation of neural activity in brain systems regulating empathy(Baseline (pre-intervention); Post-intervention (up to a week post-intervention).)
- Change in empathy(Baseline (pre-intervention); Post-intervention (up to a week post-intervention).)