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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040037
Receipt No. R000045036
Scientific Title A Single-arm Trial Investigating the Effectiveness of VR(Virtual Reality)-based Cognitive Behavioral Therapy (VR-CBT) for Adult Depression
Date of disclosure of the study information 2020/04/03
Last modified on 2020/04/03

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Basic information
Public title A Single-arm Trial Investigating the Effectiveness of VR(Virtual Reality)-based Cognitive Behavioral Therapy (VR-CBT) for Adult Depression
Acronym VR-CBT study
Scientific Title A Single-arm Trial Investigating the Effectiveness of VR(Virtual Reality)-based Cognitive Behavioral Therapy (VR-CBT) for Adult Depression
Scientific Title:Acronym VR-CBT study
Region
Japan

Condition
Condition Depression
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effectiveness of VR(Virtual Reality)-based CBT on Japanese adults with depression
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Beck Depression Inventory-2 (BDI-2)
Key secondary outcomes PHQ-9
GAD-7
SDS
PDQ-5
CSQ-8

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
Behavior,custom
Interventions/Control_1 Weekly VR-based group CBT over six weeks
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Regular access to the Internet
2) A score of 10 or more on the PHQ-9
3) Ability to both understand and agree
with informed consent in Japanese
Key exclusion criteria 1) Receiving any other CBT intervention
during the trial
2) Strong suicidal ideation
3) Schizophrenia
4) Dementia
5) Any substance addiction (except
nicotine addiction) during the 12
months prior to the trial
6) (For patients receiving treatment by a
mental health practitioner)
Unavailability of practitioner's
permission for the patient to
participate in the trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name So
Middle name
Last name Mirai
Organization Tokyo Dental College
Division name Department of Psychiatry, Ichikawa General Hospital
Zip code 272-8513
Address 5-11-13, Sugano,Ichikawa, Chiba, 272-8513, Japan
TEL 0473220151
Email somirai@tdc.ac.jp

Public contact
Name of contact person
1st name So
Middle name
Last name Mirai
Organization Tokyo Dental College
Division name Department of Psychiatry, Ichikawa General Hospital
Zip code 272-8513
Address 5-11-13, Sugano,Ichikawa, Chiba, 272-8513, Japan
TEL 0473220151
Homepage URL https://peraichi.com/landing_pages/view/vrcbt?fbclid=IwAR0jEiVf9ubGIUB7CRxpGi9k9myJ-8ycN34cvvu1D5Ptz
Email somirai@tdc.ac.jp

Sponsor
Institute Department of Psychiatry, Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hiramatsu Memorial Hospital
Address 1-20 Minami 22 Nishi 14, Sapporo, Hokkaido, Japan
Tel 011-561-0708
Email terae@hiramatsu-mhp.or.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
2020 Year 04 Month 03 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 Completed
Date of protocol fixation
2020 Year 02 Month 01 Day
Date of IRB
2020 Year 01 Month 31 Day
Anticipated trial start date
2020 Year 02 Month 14 Day
Last follow-up date
2020 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
2020 Year 04 Month 03 Day
Last modified on
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045036

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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