UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033878 |
|---|---|
| Receipt number | R000038188 |
| Scientific Title | Treatment Utilizing Virtual Reality for Social Anxiety Disorder: A Feasibility Study |
| Date of disclosure of the study information | 2018/08/24 |
| Last modified on | 2023/05/28 07:55:31 |
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Basic information
Public title
Treatment Utilizing Virtual Reality for Social Anxiety Disorder: A Feasibility Study
Acronym
Treatment Utilizing Virtual Reality for Social Anxiety Disorder: A Feasibility Study
Scientific Title
Treatment Utilizing Virtual Reality for Social Anxiety Disorder: A Feasibility Study
Scientific Title:Acronym
Treatment Utilizing Virtual Reality for Social Anxiety Disorder: A Feasibility Study
Region
| Japan |
Condition
Condition
social anxiety disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate whether the interview in which facial expressions are changed by using the virtual reality technology can be effectively and safely performed for patients with social anxiety disorder
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety of the system
Key secondary outcomes
LSAS-J score decrease at 8 weeks
LSAS-J score decrease at the end of the intervention (16 weeks)
LSAS-J score decrease at 24 weeks
FNE score decrease at 8 weeks
FNE score decrease at the end of the intervention (16 weeks)
CSQ-8 score at 8 weeks
CSQ-8 score at the end of the intervention (16 weeks)
WAI-SF score at the end of first sessions
WAI-SF score at the end of eighth sessions
WAI-SF score at the end of sixteenth sessions
dropout rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
40 minutes interview via WEB conference system (once a week over 16 weeks) in which the clinician's facial expression will be altered (smily or sadly) utilizing virtual reality technology
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with SAD (DSM-5) who are not decisionally impaired
Key exclusion criteria
History of organic mental disorders
Coexistence of substance use disorders within 12 months
History of bipolar disorder or psychotic disorder
Received other structured psychotherapy within 12 months
Coexistence of serious or unstable physical illness
Patients with moderate to severe suicidality
Judged inappropriate for the purpose of this research for other reasons by the Research Director
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Gen |
| Middle name | |
| Last name | Shiihashi |
Organization
Shonan Keiiku hospital
Division name
Doctors
Zip code
252-0816
Address
4360 Endo, Hujisawa city, Kanagawa, Japan
TEL
0466-48-0050
g-shiihashi@keiiku.gr.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Horigome |
Organization
Shonan Keiiku hospital
Division name
Doctors
Zip code
252-0816
Address
4360 Endo, Hujisawa city, Kanagawa, Japan
TEL
0466-48-0050
Homepage URL
toshirou.ho@gmail.com
Sponsor or person
Institute
Shonan Keiiku hospital
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K., Otsuka Pharmaceutical, Mochida Pharmaceutical, Shionogi, Takeda Pharmaceutical, etc
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
Shonan Keiiku hospital
Address
4360 Endo, Hujisawa city, Kanagawa, Japan
Tel
0466-48-0050
k-miyazaki@keiiku.gr.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
湘南慶育病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
https://doi.org/10.3389/fpsyg.2023.1030050
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3389/fpsyg.2023.1030050
Number of participants that the trial has enrolled
4
Results
Results suggest that this system is safe to use and may be effective in treating social anxiety disorder.
Results date posted
| 2023 | Year | 05 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1 male, 3 females, mean age; 31.0 years
Participant flow
Recruitment of the participants was conducted through referrals from their primary psychiatrists.
Adverse events
none
Outcome measures
WAI-SF, CSQ-8, LSAS-J, FNE
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038188
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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