Virtual Reality-Based Mindfulness for Caregivers of Psychiatric Patients

NCT07387562 | Active Not Recruiting

• 1 other identifier: 211/2025
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does immersive audio-based mindfulness have a greater positive impact on psychological well-being than virtual reality-mediated mindfulness?
2. 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.

Conditions

Caregivers; Caregivers Burnout

Keywords

caregivers; vr; virtual reality; mindfulness

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Mindfulness and virtual reality

EXPERIMENTAL

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.

Device: VR (VR-Control)

Mindfulness and audio

EXPERIMENTAL

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.

Device: Audio immersivo

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.

Mindfulness and virtual reality

Audio immersivo DEVICE

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.

Mindfulness and audio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Azienda Ospedaliero Universitaria Renato Dulbecco di Catanzaro: collaborator

Study Sites (1)

AOU "Renato Dulbecco"

Catanzaro, Catanzaro, 88100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)