Virtual Reality-Based Mindfulness for Caregivers of Psychiatric Patients

Istituto per la Ricerca e l'Innovazione Biomedica

Status: Active, not recruiting

Conditions: Caregivers Burnout; Caregivers

Treatments: Device: Audio immersivo; Device: VR (VR-Control)

Study type: Interventional

Funder types: Other

Identifiers

NCT07387562

211/2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Mindfulness and virtual reality

Experimental group

Description:

To examine changes in psychological factors, the same psychometric tests will be administered to both groups before and after each intervention. This group participate in a 10-minute virtual reality-mediated mindfulness protocol.

Treatment:

Device: VR (VR-Control)

Mindfulness and audio

Experimental group

Description:

To examine changes in psychological factors, the same psychometric tests will be administered to both groups before and after each intervention. This group participate in a 10-minute immersive audio-mediated mindfulness protocol.

Treatment:

Device: Audio immersivo