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Aug. 22, 2024 |
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Mar. 09, 2026 |
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jRCT1032240289 |
Exploratory study on the effectiveness of VR therapy in improving mental health |
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VR therapy and mental health |
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May. 01, 2025 |
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11 |
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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. |
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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. |
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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. |
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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. |
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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 |
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Mar. 31, 2026 |
Yes |
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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. |
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https://jrct.mhlw.go.jp/latest-detail/jRCT1032240289 |
Katsuta Narimasa |
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Juntendo University, Faculty of Medicine |
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2-1-1 Hongo Bunkyo-ku, Tokyo |
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+81-3-5802-1071 |
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nkatsuta@juntendo.ac.jp |
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Katsuta Narimasa |
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Juntendo University, Faculty of Medicine |
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2-1-1 Hongo Bunkyo-ku, Tokyo |
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+81-3-5802-1071 |
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nkatsuta@juntendo.ac.jp |
Complete |
Aug. 22, 2024 |
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| Dec. 06, 2024 | ||
| 20 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1) Adults aged 18 to 60 years |
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1) Patients whose health may be adversely affected by the use of VR devices (symptoms of severe epilepsy or dizziness) |
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| 18age old over | ||
| 60age old not | ||
Both |
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Patients with anxiety and insomnia. |
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Participants will wear the Meta Quest 2 and watch VR for a total of eight sessions over a four-week period. |
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Virtual Reality |
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D000076142 |
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D000076142 |
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Virtual Reality |
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Rate of change in Generalized Anxiety Disorder-7 (GAD-7) |
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Rate of change in Pittsburgh sleep quality index (PSQI) |
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| Juntendo Clinical Research and Trial center | |
| 2-1-1 Hongo Bunkyo-ku, Tokyo | |
+81-3-5802-1584 |
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| crbjun@juntendo.ac.jp | |
| Approval | |
Aug. 14, 2024 |
none |