UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038185 |
|---|---|
| Receipt number | R000041080 |
| Scientific Title | Effectiveness Research of web-camera delivered cognitive-behavioral therapy for the group of treatment as usual after randomized control trial of web-camera delivered cognitive-behavioral therapy for child with obsessive-compulsive disorder |
| Date of disclosure of the study information | 2019/10/02 |
| Last modified on | 2021/12/22 10:48:35 |
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Basic information
Public title
Effectiveness Research of web-camera delivered cognitive-behavioral therapy for the group of treatment as usual after randomized control trial of web-camera delivered cognitive-behavioral therapy for child with obsessive-compulsive disorder
Acronym
Effectiveness Research of web-camera delivered cognitive-behavioral therapy for the group of treatment as usual after randomized control trial of web-camera delivered cognitive-behavioral therapy for child with obsessive-compulsive disorder
Scientific Title
Effectiveness Research of web-camera delivered cognitive-behavioral therapy for the group of treatment as usual after randomized control trial of web-camera delivered cognitive-behavioral therapy for child with obsessive-compulsive disorder
Scientific Title:Acronym
Effectiveness Research of web-camera delivered cognitive-behavioral therapy for the group of treatment as usual after randomized control trial of web-camera delivered cognitive-behavioral therapy for child with obsessive-compulsive disorder
Region
| Japan |
Condition
Condition
obsessive-compulsive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate the effectiveness of web-camera delivered cognitive behavioral therapy for children with obsessive compulsive disorder in treatment as usual group after randomized controlled trials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of CY-BOCS(Child Yale-Brown obsessive-compulsive scale) at 16 weeks from the beginning.
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cognitive behavioral therapy
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
| 10 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary diagnosis of obsessive-compulsive disorder
Key exclusion criteria
psychotic disorder
active suicidality
organic brain disorder
antisocial personality disorder
mental retardation
other severe mental / physical condition
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kuno |
Organization
Chiba university
Division name
Research center for child mental development
Zip code
2608670
Address
1-8-1, Inohana, Chuouku, Chiba, Japan
TEL
0432262975
m-kuno@chiba-u.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Kuno |
Organization
Chiba university
Division name
Research center for child mental development
Zip code
2608670
Address
1-8-1, Inohana, Chuouku, Chiba, Japan
TEL
0432262975
Homepage URL
m-kuno@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
japan society for the promotion of science
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
Chiba University Hospital Clinical Research Center
Address
1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN
Tel
0432227171
shiken@office.chiba-u.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
| 2019 | Year | 10 | Month | 02 | 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
4
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
| 2019 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041080
| 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 |
