A Novel Virtual Reality Intervention for Caregivers of People With Dementia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in anxiety
时间窗: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
State Trait Anxiety Inventory - STAI-Y
Change in distress of care after intervention
时间窗: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Zarit Burden interview - ZBI
次要结局
- 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).)
研究者
Cristina Festari, PhD
Researcher
IRCCS Centro San Giovanni di Dio Fatebenefratelli