UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040837 |
|---|---|
| Receipt number | R000046623 |
| Scientific Title | A Randomized Controlled trial Investigating the Effectiveness of VR(Virtual Reality)-based Cognitive Behavioral Therapy (VR-CBT) for Adult Depression in the Covid-19 Pandemic |
| Date of disclosure of the study information | 2020/06/24 |
| Last modified on | 2023/05/07 13:06:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Randomized Controlled trial Investigating the Effectiveness of VR(Virtual Reality)-based Cognitive Behavioral Therapy (VR-CBT) for Adult Depression in the Covid-19 Pandemic
Acronym
VR-CBT study (RCT)
Scientific Title
A Randomized Controlled trial Investigating the Effectiveness of VR(Virtual Reality)-based Cognitive Behavioral Therapy (VR-CBT) for Adult Depression in the Covid-19 Pandemic
Scientific Title:Acronym
VR-CBT study (RCT)
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
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BDI-2 (baseline, 7 weeks post-interbention and 3 months follow-up)
Key secondary outcomes
PHQ-9
GAD-7
SDS
PDQ-5
HPQ(persentism)
CSQ-8
dropout
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
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
Weekly web-based group psycho-education over six weeks
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 5 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
100
Research contact person
Name of lead principal investigator
| 1st name | Mirai |
| Middle name | |
| Last name | So |
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
somirai@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Mirai |
| Middle name | so |
| Last name | So |
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
somirai@tdc.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
Society for the Promotion of Science
Grant-in-Aid for Scientific Research
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
Department of Psychiatry, Tokyo Dental College Ichikawa General Hospital
Address
5-11-13, Sugano,Ichikawa, Chiba, 272-8513, Japan
Tel
047-322-0151
irb@tdc.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
| 2020 | Year | 06 | 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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | 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 | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046623
