Caregiver Burden
Conditions
Keywords
Informal caregiver, Virtual reality, Psychoeducation intervention
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.
Interventions
BEHAVIORALPsychoeducation
6 sessions of 2 hours over 6 weeks
BEHAVIORALPsychoeducation + 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).
Sponsors
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Alzheimer's Association
University of Bergamo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two-arm randomized controlled design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORCristina Festari, PhD
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
Outcome results
None listed