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Japanese

Aug. 22, 2024

Mar. 09, 2026

jRCT1032240289

Exploratory study on the effectiveness of VR therapy in improving mental health

VR therapy and mental health

May. 01, 2025

11

The mean age was 35.0 years, and 60% were women. The primary diagnoses were anxiety/adjustment disorder (40%), mood disorder (30%), somatic symptom disorder (20%), and insomnia (10%). Furthermore, 80% were taking psychotropic medications. The mean baseline scores for each clinical scale were 9.9 for the GAD-7, 12.6 for the PHQ-9, and 10.3 for the PSQI.

Eleven patients who met the eligibility criteria were enrolled; one patient discontinued during the second week due to device-related stress, while 10 patients completed the study and were included in the analysis.

Regarding safety, although three subjects (30%) reported minor and transient discomfort such as eye strain and dizziness, no serious adverse events (SAEs) were observed, and no intervention discontinuations occurred due to simulator sickness.

Anxiety symptoms (GAD-7) scores decreased in 9 of 10 participants, with the overall mean score decreasing from 9.9 to 5.9 points (mean change -4.0 points, effect size Cohen's dz = 1.43). Depressive symptoms (PHQ-9) improved in 7 of 10 participants, with the mean score decreasing from 12.6 to 8.5 points (mean change -4.1 points, dz = 0.91). Sleep index (PSQI) scores decreased in 8 of 10 participants, with the mean score decreasing from 10.3 to 8.3 points (mean change -2.0 points, dz = 0.95), although the improvement was more limited than for anxiety and depression.

This exploratory study demonstrated that a 4-week, home-based self-guided VR-scenery relaxation intervention for outpatients with comorbid insomnia and anxiety symptoms was feasible, safe, and generally well tolerated. The completion rate was high (91%), and protocol adherence among completers was also good. No serious adverse events were observed, and reported discomfort was primarily mild and transient. Although there were individual differences in willingness to reuse, it appears feasible for home admini

Mar. 31, 2026

Yes

The data obtained in this study may be used for secondary purposes without linking it to personal identifying information, only if approved after review by an appropriate ethical review committee.

https://jrct.mhlw.go.jp/latest-detail/jRCT1032240289

Katsuta Narimasa

Juntendo University, Faculty of Medicine

2-1-1 Hongo Bunkyo-ku, Tokyo

+81-3-5802-1071

nkatsuta@juntendo.ac.jp

Katsuta Narimasa

Juntendo University, Faculty of Medicine

2-1-1 Hongo Bunkyo-ku, Tokyo

+81-3-5802-1071

nkatsuta@juntendo.ac.jp

Complete

Aug. 22, 2024

Dec. 06, 2024
20

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Adults aged 18 to 60 years
2) Patients currently receiving treatment for anxiety and insomnia
3) Patients with a score of 5 or higher on the Generalized Anxiety Disorder Questionnaire (GAD-7)
4) Patients with a score of 6 or higher on the Pittsburgh Sleep Quality Index (PSQI)
5) Patients who understand and consent to using VR devices

1) Patients whose health may be adversely affected by the use of VR devices (symptoms of severe epilepsy or dizziness)
2) Pregnant or potentially pregnant patients
3) Patients with restrictive physical conditions (severe visual or hearing impairments)
4) Patients who are unable to create an environment requiring Wi-Fi connection
5) Patients with a score of less than 5 on the Generalized Anxiety Disorder Questionnaire (GAD-7)
6) Patients with a score of less than 6 on the Pittsburgh Sleep Quality Index (PSQI)
7) Other individuals who the principal investigator judges to be unsuitable based on their current medical history, medical treatment history, disease name, etc.

18age old over
60age old not

Both

Patients with anxiety and insomnia.

Participants will wear the Meta Quest 2 and watch VR for a total of eight sessions over a four-week period.
This will be up to two times a week, and each session will last 20 minutes.

Virtual Reality

D000076142

D000076142

Virtual Reality

Rate of change in Generalized Anxiety Disorder-7 (GAD-7)

Rate of change in Pittsburgh sleep quality index (PSQI)

Juntendo Clinical Research and Trial center
2-1-1 Hongo Bunkyo-ku, Tokyo

+81-3-5802-1584

crbjun@juntendo.ac.jp
Approval

Aug. 14, 2024

none

History of Changes

No Publication date
4 Mar. 31, 2026 (this page) Changes
3 Sept. 05, 2025 Detail Changes
2 April. 10, 2025 Detail Changes
1 Aug. 22, 2024 Detail