CaregiversNCT07387562
Virtual Reality-Based Mindfulness for Caregivers of Psychiatric Patients
A study testing Audio immersivo in people with Caregivers and Caregivers Burnout, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Caregivers Burnout
- What is being tested?
- Audio immersivo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health Treatment in Caregivers of Psychiatric Patients: Application of Virtual Reality-Mediated Mindfulness
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:
- Does immersive audio-based mindfulness have a greater positive impact on psychological well-being than virtual reality-mediated mindfulness?
- 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.
Read more
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.
Read the detailed 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.
- Conditions
- Caregivers, Caregivers Burnout
- Being tested
- VR (VR-Control), Audio immersivo
- Keywords
- caregivers, vr, virtual reality, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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:
- "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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Audio immersivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI)
Measured: From enrollment to the end of treatment at 4 weeks
Beck Depression Inventory (BDI-II)
Measured: From enrollment to the end of treatment at 4 weeks
Italian Mental Health Continuum - Short Form (MHC-SF)
Measured: From enrollment to the end of treatment at 4 weeks
Perceived Stress Scale (PSS-10)
Measured: From enrollment to the end of treatment at 4 weeks
WHO-5
Measured: From enrollment to the end of treatment at 4 weeks
Mindful Attention Awareness Scale (MAAS)
Measured: From enrollment to the end of treatment at 4 weeks
Zarit Burden Interview (ZBI)
Measured: From enrollment to the end of treatment at 4 weeks
Scale of Positive and Negative Experiences (SPANE)
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Renato Dulbecco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387562
- Sponsor's protocol ID
- 211/2025
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Treatment in Caregivers of Psychiatric Patients: Application of Virtual Reality-Mediated Mindfulness
- ClinicalTrials.gov ID
- NCT07387562
- Acronym / sponsor ID
- 211/2025
- Conditions
- Caregivers, Caregivers Burnout
- Keywords
- caregivers, vr, virtual reality, mindfulness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Renato Dulbecco
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does immersive audio-based mindfulness have a greater positive impact on psychological well-being than virtual reality-mediated mindfulness?
- 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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and virtual reality | Experimental | Device: VR (VR-Control)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. |
| Mindfulness and audio | Experimental | Device: Audio immersivoTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Mindfulness and virtual reality |
| Audio immersivoIn 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. | Device | Mindfulness and audio |
Primary outcome
State-Trait Anxiety Inventory (STAI)
Time frame: From enrollment to the end of treatment at 4 weeks
Beck Depression Inventory (BDI-II)
Time frame: From enrollment to the end of treatment at 4 weeks
Italian Mental Health Continuum - Short Form (MHC-SF)
Time frame: From enrollment to the end of treatment at 4 weeks
Perceived Stress Scale (PSS-10)
Time frame: From enrollment to the end of treatment at 4 weeks
WHO-5
Time frame: From enrollment to the end of treatment at 4 weeks
Mindful Attention Awareness Scale (MAAS)
Time frame: From enrollment to the end of treatment at 4 weeks
Zarit Burden Interview (ZBI)
Time frame: From enrollment to the end of treatment at 4 weeks
Scale of Positive and Negative Experiences (SPANE)
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio immersivo in people with Caregivers and Caregivers Burnout, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.