UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062513 |
|---|---|
| Receipt number | R000058061 |
| Scientific Title | An Observational Study on the Effects of Social Skills Training Using Virtual Reality on Social Functioning |
| Date of disclosure of the study information | 2026/08/07 |
| Last modified on | 2026/08/07 17:00:12 |
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Basic information
Public title
An Observational Study on the Effects of Social Skills Training Using Virtual Reality on Social Functioning
Acronym
eSOLV
Scientific Title
An Observational Study on the Effects of Social Skills Training Using Virtual Reality on Social Functioning
Scientific Title:Acronym
eSOLV
Region
| Japan |
Condition
Condition
Regardless of the target disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of Social Skills Training (SST) using Virtual Reality (VR) on the function of interpersonal interaction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SLOF total score
Key secondary outcomes
Background information: age, gender, diagnosis, prescribed medications, duration of illness
Cognitive function tests: Continuous Performance Test (CPT), The Rivermead Behavioural Memory Test (RBMT)
Adverse events: The simulator sickness questionnaire (SSQ)
Psychiatric symptoms: The clinical global impressions scale severe (CGI-S), CGI improvement (CGI-I)
Social functioning: global assessment of functioning (GAF)
Pre-symptomatic IQ: Japanese Adult Reading Test (JART)
Eye movements: data acquired from VR device viewpoints
Discussion of users during VRSST
Impressions at the end of the VRSST program
Sub-scales of each rating scale
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients (regardless of disease) receiving treatment at the Department of Neuropsychiatry, Kansai Medical University General Medical Center
Patients who have given consent to participate in the study
Key exclusion criteria
Patients determined by the principal investigator to be inappropriate as research subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshiteru |
| Middle name | |
| Last name | Takekita |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry, Faculty of Medicine
Zip code
570-8506
Address
10-15 fumizono-cho, Moriguchi Osaka, Japan
TEL
0669921001
takekity@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Koshikawa |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry, Faculty of Medicine
Zip code
570-8506
Address
10-15 fumizono-cho, Moriguchi Osaka, Japan
TEL
0669921001
Homepage URL
koshikay@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Yoshiteru Takekita
Funding Source
Organization
Kansai Medical 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
Institutional Review Board in Kansai Medical University
Address
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
Tel
0669921001
rinriirb@hirakata.kmu.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
関西医科大学総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058061
