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NCT Number: NCT07387562

Virtual Reality-Based Mindfulness for Caregivers of Psychiatric Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Caregivers Caregivers Burnout

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU "Renato Dulbecco"

Catanzaro, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • observing the situation in "The Secret Garden";
  • observing the "Sunset Beach" situation;
  • 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

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:

  • "The Secret Garden" immersive audio;
  • "Sunset Beach" immersive audio;
  • "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.

Primary outcomes

  1. State-Trait Anxiety Inventory (STAI)

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. Beck Depression Inventory (BDI-II)

    Time frame: From enrollment to the end of treatment at 4 weeks

  3. Italian Mental Health Continuum - Short Form (MHC-SF)

    Time frame: From enrollment to the end of treatment at 4 weeks

  4. Perceived Stress Scale (PSS-10)

    Time frame: From enrollment to the end of treatment at 4 weeks

  5. WHO-5

    Time frame: From enrollment to the end of treatment at 4 weeks

  6. Mindful Attention Awareness Scale (MAAS)

    Time frame: From enrollment to the end of treatment at 4 weeks

  7. Zarit Burden Interview (ZBI)

    Time frame: From enrollment to the end of treatment at 4 weeks

  8. Scale of Positive and Negative Experiences (SPANE)

    Time frame: From enrollment to the end of treatment at 4 weeks

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Collaborators

  • Azienda Ospedaliera Universitaria Renato Dulbecco

Registry information

Official study title

Mental Health Treatment in Caregivers of Psychiatric Patients: Application of Virtual Reality-Mediated Mindfulness

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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