Virtual Reality-Based Mindfulness for Caregivers of Psychiatric Patients

This clinical investigation aims to compare the mental health status of caregivers of psychiatric patients before and after virtual reality-based mindfulness. The study's primary objectives are to: 1. Does immersive audio-based mindfulness have a greater positive impact on psychological well-being than virtual reality-mediated mindfulness? 2. When compared to a single session, do four sessions lead to more improvements in psychological well-being? To assess the additional impact of virtual reality-mediated mindfulness, participants in the control group will receive mindfulness via immersive audio. Those who voluntarily sign up for the study will participate in four sessions, one each week, on the same day and at the same time. Prior to and following the mindfulness intervention, self-administered psychometric assessment batteries will be completed. While the control group will use ears to complete the mindfulness session using immersive audio, the experimental group will get a virtual reality-mediated mindfulness intervention. BECOME is the company that provides the audio and video content.

NCT Number	NCT07387562
Lead Sponsor	Istituto per la Ricerca e l'Innovazione Biomedica Collaborators: Azienda Ospedaliera Universitaria Renato Dulbecco
Conditions	Caregivers, Caregivers Burnout
Enrollment	46 participants
Start Date	2025-09-01
Primary Completion	2026-06 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-02-04