Virtual Reality-Based Mindfulness for Caregivers of Psychiatric Patients

N/AActive Not RecruitingNCT07387562

Istituto per la Ricerca e l'Innovazione Biomedica46 enrolled

Overview

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.

In a sample of caregivers who visit the Department of Psychiatry at the "Renato Dulbecco" University Hospital in Catanzaro, the effects of the combined VR plus immersive audio treatment will be compared with the effects of immersive audio stimulation alone using a randomized controlled trial (RCT) design. The main goal is to evaluate how much the experimental group's caregivers' mental health has improved both before and after therapy. The following self-report measures will be used for assessment: The World Health Organization Well-Being Index (WHO-5), the Zarit Burden Interview (ZBI), the Perceived Stress Scale (PSS-10), the Italian Mental Health Continuum-Short Form (MHC-SF), the Scale of Positive and Negative Experiences (SPANE), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Pittsburgh Sleep Quality Index (PSQI). Assessing variations in treatment effectiveness between the experimental and control groups is the secondary goal.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Interventions

VR (VR-Control)DEVICE

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 immersivoDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years. * Being the primary caregiver of a psychiatric patient with a clinically confirmed diagnosis for at least 6 months. * Willingness to participate for the entire duration of the study. * Signed informed consent. Exclusion Criteria: * Active psychiatric diagnosis in the acute phase. * Previous regular use of mindfulness techniques or other relaxation techniques at any point in life. * Current use of psychotropic medications by the caregiver. * Photosensitive epilepsy (due to VR headset use). * Severe cognitive or sensory impairment. * Binocular vision abnormalities. * Hearing aids.