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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043020
Receipt No. R000049109
Scientific Title Development and evaluation of VR application to reduce the stigma of depression: Randomized controlled trial
Date of disclosure of the study information 2021/01/20
Last modified on 2021/01/15

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Basic information
Public title Development and evaluation of VR application to reduce the stigma of depression
Acronym Development and evaluation of VR application to reduce the stigma of depression
Scientific Title Development and evaluation of VR application to reduce the stigma of depression: Randomized controlled trial
Scientific Title:Acronym Development and evaluation of VR application to reduce the stigma of depression: Randomized controlled trial
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop and evaluate the effectiveness of the VRAS application as an educational tool compared to the video material in reducing public stigma of depression
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The stigma level measured by Depression Stigma Scale(DSS)
Key secondary outcomes The social distance measured by Attitudinal Social Distance(ASD)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The participants experience the VR application; 5min x 1
Interventions/Control_2 The participants watch the video about depression; 5min x 1
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy students over twenty years old
Key exclusion criteria 1)Currently diagnosed with depression
2)Having history of depression
3)Drop out from the intervention due to unforeseen reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Oyama
Organization School of Public Health, Graduate School of Medicine, The University of Tokyo
Division name Department of Clinical Information Engineering
Zip code 1130022
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-1893
Email hoyama@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Ayako
Middle name
Last name Kohyama
Organization School of Public Health, Graduate School of Medicine, The University of Tokyo
Division name Department of Clinical Information Engineering
Zip code 1130022
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-1893
Homepage URL
Email akohyama@m.u-tokyo.ac.jp

Sponsor
Institute University of Tokyo
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5841-0818
Email ethics@m.u-tokyo.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
2021 Year 01 Month 20 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 20
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 No longer recruiting
Date of protocol fixation
2019 Year 08 Month 04 Day
Date of IRB
2019 Year 07 Month 17 Day
Anticipated trial start date
2019 Year 09 Month 04 Day
Last follow-up date
2021 Year 03 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 15 Day
Last modified on
2021 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049109

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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