Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Alzheimer Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Int J Geriatr Psychiatry. 2024 Sep;39(9):e6145. doi: 10.1002/gps.6145.
Care for community-dwelling people with dementia is frequently delegated to relatives, who find themselves in the role of informal caregivers with no practical management knowledge. This situation exposes caregivers to increased risk for emotional wellbeing. The current study aims to test whether the integration of the efficacy of an immersive virtual reality (VR) experience into an online psychoeducational program impacts caregiver empathy and therefore emotional wellbeing.
One-hundred informal caregivers of mild-to-moderate Alzheimer's disease (AD) patients will be enrolled and randomly assigned to (i) an online psychoeducational program (control arm); or (ii) an online psychoeducational program integrated with VR (experimental arm). VR will consist of 360-degree videos involving the caregivers to an immersive experience of dementia symptoms from the patient's perspective. Before, after the intervention and after 2 months, all participants will complete validated clinical scales for caregiver burden and anxiety (primary outcomes) and sense of competence and dispositional empathy (secondary outcomes). A subsample of 50 participants will also undergo MRI exam, including structural and functional (resting-state and task-functional MRI [fMRI]) sequences. The fMRI task paradigm will use emotional stimuli to evaluate the neural correlate of empathy, by stressing its cognitive and affective components. The main outcome will be the change in the clinical assessment; the secondary outcome will be the change in brain connectivity of networks subserving the empathic and emotional functioning.
We expect that the psychoeducational program will decrease anxiety and stress, enabling caregivers to perceive themselves capable of managing AD patients at home, educating them on symptom handling and boosting their cognitive empathy. In the experimental intervention, the VR-based experience will act as an add-on to psychoeducation, leading to greater improvement in the assessed clinical dimensions. VR should, in fact, enable a deeper understanding of disease symptoms and improve caregivers' cognitive empathy. We expect that the experimental intervention will result in deeper comprehension of disease symptoms and further strengthen caregivers' cognitive empathy. At the neural level, we expect to observe increased activation in circuits subserving cognitive empathy and decreased activation in circuits underlying affective empathy.
To the best of our knowledge, this will be the first randomized controlled trial assessing the effect of combining psychoeducational interventions with VR-based experience in caregivers, and assessing both clinical and imaging outcomes.
Registered in ClinicalTrials.gov (NCT05780476).
照料社区内患有痴呆症的人群通常由亲属承担，他们在没有实际管理知识的情况下成为非正式照护者。这种情况使照护者面临更大的情绪健康风险。本研究旨在测试将沉浸式虚拟现实 (VR) 体验的功效融入在线心理教育计划是否会影响照护者的同理心，从而影响其情绪健康。
将招募 100 名轻度至中度阿尔茨海默病 (AD) 患者的非正式照护者，并将他们随机分配到（i）在线心理教育计划（对照组）；或（ii）在线心理教育计划与 VR 相结合（实验组）。VR 将包括 360 度视频，让照护者从患者的角度沉浸式体验痴呆症症状。在干预前、干预后和 2 个月后，所有参与者将完成经过验证的照护者负担和焦虑（主要结局）以及能力感和倾向性同理心（次要结局）的临床量表。一个 50 名参与者的子样本将接受 MRI 检查，包括结构和功能（静息态和任务功能 MRI [fMRI]）序列。fMRI 任务范式将使用情绪刺激来评估同理心的神经相关性，强调其认知和情感成分。主要结果将是临床评估的变化；次要结果将是同理心和情绪功能的网络的脑连接变化。
我们预计心理教育计划将降低焦虑和压力，使照护者能够感知自己有能力在家中管理 AD 患者，对他们进行症状处理教育，并提高他们的认知同理心。在实验组中，基于 VR 的体验将作为心理教育的附加内容，导致评估的临床维度有更大的改善。实际上，VR 应该能够更深入地了解疾病症状，并提高照护者的认知同理心。我们预计实验组干预将导致对疾病症状的更深入理解，并进一步增强照护者的认知同理心。在神经水平上，我们预计会观察到认知同理心相关回路的激活增加，而情感同理心相关回路的激活减少。
据我们所知，这将是第一项评估将基于 VR 的体验与心理教育干预相结合对照护者进行干预，并评估临床和影像学结果的随机对照试验。
ClinicalTrials.gov 注册（NCT05780476）。
