UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043218 |
|---|---|
| Receipt number | R000049319 |
| Scientific Title | VR-CBT for Rumination (Single arm, Prospective Interventional Study) |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2022/08/03 01:16:04 |
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Basic information
Public title
VR-CBT for Rumination
Acronym
VR-CBT for Rumination
Scientific Title
VR-CBT for Rumination (Single arm, Prospective Interventional Study)
Scientific Title:Acronym
VR-CBT for Rumination
Region
| Japan |
Condition
Condition
rumination
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to test the effectiveness of VR-based cognitive behavioral therapy on people suffering from rumination. The participants will experience distancing themselves from the emotions and behaviors behind rumination through the third-generation cognitive-behavioral therapy using VR, and we will evaluate whether the images experienced in VR can be fixed, suppress the appearance of rumination, and reduce depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rumination: Repetitive Thinking Questionnaire
Key secondary outcomes
Depression: Self-rating Depression Scale
Frequency of occurrence of rumination and psychological burden caused by rumination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
In addition to regular medical care, VR-CBT will be conducted; VR-CBT will be conducted in a total of five sessions.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Those who are 18 years old or older at the time of obtaining consent
2)Rumination is observed.
3)Applicants who are able to wear VR goggles.
4)Those who are able to understand instructions in Japanese necessary for conducting research.
Key exclusion criteria
1)When it is judged that it is difficult to carry out the research due to a medical condition.
2)Those who have difficulty wearing VR goggles due to sensory sensitivity, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Okada |
Organization
Kumegawa Hospital
Division name
Psycho-somatic Internal Medicine
Zip code
761-0102
Address
Koh 474-3, Shinden-cho, Takamatsu, Kagawa, Japan
TEL
087-844-3111
okadaedu@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayo |
| Middle name | |
| Last name | Matsumura |
Organization
BiPSEE, Inc.
Division name
Research Department
Zip code
160-0004
Address
4-28-7, Yotsuya, Shinku-ku, Tokyo, Japan
TEL
03-6555-3012
Homepage URL
m.matsumura@bipsee.co.jp
Sponsor or person
Institute
BiPSEE, Inc.
Institute
Department
Personal name
Funding Source
Organization
BiPSEE, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Foundation for Health and Preventive Medicine
Address
3-6-17, Nakamachi, Atsugi, Kanagawa, Japan
Tel
046-206-2112
y.sakurai@h-p-m.org
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 | 02 | Month | 01 | 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
| Delay expected |
Results Delay Reason
Due to the time required to process and analyze the data
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
| 2020 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
