Virtual Reality-Based Mindfulness for Caregivers of Psychiatric Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• State-Trait Anxiety Inventory (STAI) — From enrollment to the end of treatment at 4 weeks
• Beck Depression Inventory (BDI-II) — From enrollment to the end of treatment at 4 weeks
• Italian Mental Health Continuum - Short Form (MHC-SF) — From enrollment to the end of treatment at 4 weeks
• Perceived Stress Scale (PSS-10) — From enrollment to the end of treatment at 4 weeks
• WHO-5 — From enrollment to the end of treatment at 4 weeks
• Mindful Attention Awareness Scale (MAAS) — From enrollment to the end of treatment at 4 weeks
• Zarit Burden Interview (ZBI) — From enrollment to the end of treatment at 4 weeks
• Scale of Positive and Negative Experiences (SPANE) — From enrollment to the end of treatment at 4 weeks

Trial sites (1)

More Istituto per la Ricerca e l'Innovazione Biomedica trials in Italy