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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033878
Receipt No. 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 2019/08/24

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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 Misa
Middle name
Last name Wakaki
Organization Shonan Keiiku hospital
Division name Doctors
Zip code 252-0816
Address 4360 Endo, Hujisawa city, Kanagawa, Japan
TEL 0466-48-0050
Email m-wakaki@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
Email toshirou.ho@gmail.com

Sponsor
Institute Shonan Keiiku hospital
Institute
Department

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
Email 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
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
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
2019 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038188

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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