UMIN-CTR Clinical Trial

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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