UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061822 |
|---|---|
| Receipt number | R000070679 |
| Scientific Title | A Multicenter Study on the Improvement of Interpersonal Skills and Social Functioning in Patients with Schizophrenia through Virtual Reality-Based Social Skills Training (VR-SST) |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/07 17:59:51 |
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Basic information
Public title
A study to examine the effects of virtual reality-based social skills training on interpersonal skills and social functioning in people with schizophrenia
Acronym
VR-SST Study for People with Schizophrenia
Scientific Title
A Multicenter Study on the Improvement of Interpersonal Skills and Social Functioning in Patients with Schizophrenia through Virtual Reality-Based Social Skills Training (VR-SST)
Scientific Title:Acronym
Multicenter Study of VR-SST for Patients with Schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treatment and care
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the total score of the Brief Negative Symptom Scale (BNSS) from baseline to post-intervention
Key secondary outcomes
Intervention completion rate, missing data rate, Patient Health Questionnaire-9 Japanese version (PHQ-9), EQ-5D-5L, UCLA Loneliness Scale, Satisfaction With Life Scale (SWLS), Social Functioning Scale (SFS), Quality of Life Scale (QLS), and adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the VR-SST group will receive VR-SST using FACEDUO once a week for 60 minutes over six months, for a total of 24 sessions. The program consists of 19 mandatory contents and 5 optional contents selected according to each participant's needs and preferences.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
1. Patients who meet the DSM-5 diagnostic criteria for schizophrenia
2. Patients who have been stably attending psychiatric day care for at least one month
3. Patients aged 18 years or older and under 60 years
4. Patients judged by their attending psychiatrist to be able to participate in the study
5. Patients who receive an explanation of the study and provide written informed consent
Key exclusion criteria
Exclusion Criteria
Patients who meet any of the following criteria will be excluded:
1. Patients who have difficulty understanding the study and cannot provide sufficient informed consent
2. Patients whose capacity to consent is considered uncertain based on confirmation of understanding during the explanation process
3. Patients whose psychiatric symptoms are unstable and who are judged by their attending psychiatrist to be unsuitable for participation
4. Patients who score 1 or higher on item 9 of the PHQ-9, which assesses suicidal ideation
5. Patients with a history of seizure disorders, including epilepsy
6. Patients with a history of severe motion sickness or who are expected to be at high risk of VR sickness
7. Patients with severe cognitive impairment or other conditions that make participation in VR-SST difficult
8. Patients with intellectual disability
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Anzai |
Organization
Teikyo Heisei University
Division name
Graduate School of Clinical Psychology
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima, Tokyo
TEL
03-5843-3111
nanzai@nifty.com
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Anzai |
Organization
Teikyo Heisei University
Division name
Graduate School of Clinical Psychology
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima, Tokyo
TEL
03-5843-3111
Homepage URL
nanzai@nifty.com
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Nobuo Anzai
Funding Source
Organization
Teikyo Heisei University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo Heisei University Research Ethics Committee for Studies Involving Human Participants
Address
2-51-4 Higashi-Ikebukuro, Toshima, Tokyo
Tel
03-5843-3111
rec@thu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2028 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2028 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 07 | Day |
Last modified on
| 2026 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070679
