Virtual Reality-Based Mindfulness for Caregivers of Psychiatric Patients

Summary

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.

Conditions

• Caregivers
• Caregivers Burnout

Interventions

DEVICE

VR (VR-Control)

Using the Meta Quest Pro headset, participants will participate in four virtual reality mindfulness exercises designed to improve relaxation and body awareness. Become's proprietary system (https://discoverbecome.com/) will be used for the sessions. The following is how the immersive "Augmented Wellbeing" sessions will be organized: 1. observing the situation in "The Secret Garden"; 2. observing the "Sunset Beach" situation; 3. observing the "Waterfall in the Meadow" situation; Reviewing the earlier sessions after viewing a scenario chosen by the participants to encourage self-determination and involvement.

DEVICE

Audio immersivo

In order to improve body awareness and relaxation, participants will participate in four audio-only mindfulness sessions (immersive mindfulness audio). The same firm, BECOME, provides the audio track, which is the same as the one used in the VR immersive sessions. The number and length of sessions completed by participants will be identical to those of the experimental group, and the sessions will follow the same format: 1. "The Secret Garden" immersive audio; 2. "Sunset Beach" immersive audio; 3. "Waterfall in the Meadow" immersive audio; Audio chosen by the participants to encourage participation and self-determination, followed by a recap of the earlier sessions.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Renato Dulbecco di Catanzaro

  collaborator UNKNOWN

• Istituto per la Ricerca e l'Innovazione Biomedica

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• Italy

Study Locations