AbstractBackgroundCare for community‐dwelling people with dementia (PwD) is frequently delegated to relatives, who find themselves in the role of informal caregivers (iCGs) with no practical knowledge to manage their loved ones. This situation puts iCGs at high risk for emotional distress. We will assess the efficacy of an online psycho‐educational program combined with an immersive virtual reality (VR) experience to reduce iCGs perceived stress by acting on the cognitive and affective components of empathy.MethodUsing covariate‐adaptive (by sex and baseline level of perceived stress) randomization, 100 iCGs of mild‐to‐moderate Alzheimer’s disease patients will be assigned to i) an online 6‐week psycho‐educational program (control arm); or ii) the same psycho‐educational program integrated with VR (experimental arm). VR consists of 360‐degree videos and allows caregivers to experience dementia symptoms from the patient’s perspective. The primary outcome will be a change in emotional distress, assessed with the Zarit Burden Inventory and the State‐Trait Anxiety Inventory. In addition, changes in brain activity while reading emotional stories (protocol modified from Ashar, 2017) will be assessed as a secondary outcome in a subsample of 50 participants who will undergo magnetic resonance imaging. Primary and secondary outcomes will be measured before and after the intervention. A 2‐month clinical follow‐up is also scheduled.ResultTo date, 20 iCGs (mean age: 58; range 30‐79; female: 75%; children: 55%) have been randomized to the 2 arms. The psycho‐educational program provides support for the home management of PwD, by offering knowledge on symptom management and enhancing strategies based on the cognitive component of empathy. During each session, iCGs are exposed to 30 minutes of empathy training with i) imagery exercises or ii) VR. The experimental intervention is expected to result in deeper disease comprehension and strengthen empathy’s cognitive component. At the network level, we expect to observe a greater activation of cognitive empathy circuits and a lower activation of affective empathy circuits in the experimental group.ConclusionTo our knowledge, this will be the first randomized controlled trial assessing the synergistic effect of combining traditional psycho‐educational intervention with VR in iCGs and measuring both clinical and imaging markers.
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