NCT07655063

Brief Summary

This study evaluates the feasibility, acceptability and clinical impact of a virtual reality (VR)- based nature intervention in an acute psychiatric inpatient unit. Participants are randomly assigned to recieve VR nature sessions (using Nature Treks VR on Meta Quest 3) in addition to standard care, or standard care alone. The primary outcome is change in percieved stress (PSS-19) from admission to discharge. The study uses a mixed-methods design combining randomized controlled trial with a qualitative phase.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

June 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 9, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

virtual realitynature exposureAcute psychiatryInpatientMental health

Outcome Measures

Primary Outcomes (1)

  • Change in Perceived Stress Scale-10 (PSS-10) score

    Change in PSS-10 total score from baseline assessment (T0, al clinical stabilization) to discharge assessment (T2). The Perceived Stress Scale-10 (PSS-10) is a 10-item self-report questionnaire measuring the degree to which situations in one's life are appraised as stressful. Scores range from 0 to 40, with higher scores indicating greater perceived stress.

    From admission (baseline) to discharge (average 2-3 weeks)

Secondary Outcomes (10)

  • World Health Organization-Five Well-Being Index (WHO-5) score

    Through study completion, an average of 2 weeks

  • Views On Inpatient Care (VOICE) score

    Through study completion, an average of 2 weeks

  • Client's Assessment of Treatment (CAT) score

    Through study completion, an average of 2 weeks

  • Length of hospital stay

    From admission to discharge, an average of 2 weeks

  • Rate of discharge against medical advice (DAMA)

    Throughout hospitalization, an average 2 weeks.

  • +5 more secondary outcomes

Study Arms (2)

VR + Treatment as Usual

EXPERIMENTAL

Participants receive voluntary VR nature sessions (10-15 minutes, every other day) using Meta Quest 3, in addition to standar psychiatric care.

Behavioral: Virtual Reality Nature Exposure

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participantrs receive standard pharmacological and psychotherapeutic care provided by the acute psychiatry ward, without VR sessions.

Other: Treatment as Usual (TAU)

Interventions

Voluntary immersive nature sessions using Nature Treks VR softwere on Meta Quest 3 head-mounted displays. Sessions last 10-15 minutes and are offered every other day throughout hospitalization. Participants freely choose among all available nature environments within the application.

VR + Treatment as Usual

Standard pharmacological and psychotherapeutic interventions provided by the acute psychiatry ward.

Treatment as Usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 65 years. Admitted to the Acute Psychiatry Ward (regardless of voluntary or involuntary legal status).
  • Sufficient cognitive and clinical stability to provide informed consent and engage with the VR equipment, as determined by the clinical team.
  • Ability to communicate effectively in Spanish.

You may not qualify if:

  • History of photosensitive epilepsy or severe seizure disorders. Presence of active facial injuries, infections, or skin conditions that prevent the hygienic use of the VR headset.
  • Pre-existing severe vertigo, balance disorders, or high susceptibility to motion sickness.
  • Acute clinical state involving high risk of agitation or behavioral dysregulation that could compromise participant or equipment safety.
  • Severe visual or hearing impairments that cannot be corrected and would hinder the VR experience.
  • Patients who have previously participated in the study during a prior admission are not eligible for re-enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Location

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Pablo Barrio Gimenez

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 17, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 17, 2026

Record last verified: 2025-06

Locations