UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039375 |
|---|---|
| Receipt number | R000044422 |
| Scientific Title | Guided Internet-based cognitive behavioral therapy for obsessive-compulsive disorder: a randomized comparison / assessment blind test |
| Date of disclosure of the study information | 2020/02/03 |
| Last modified on | 2022/02/03 16:54:30 |
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Basic information
Public title
Guided Internet-based cognitive behavioral therapy for obsessive-compulsive disorder: a randomized comparison / assessment blind test
Acronym
Guided ICBT for OCD: a randomized comparison / assessment blind test
Scientific Title
Guided Internet-based cognitive behavioral therapy for obsessive-compulsive disorder: a randomized comparison / assessment blind test
Scientific Title:Acronym
Guided ICBT for OCD: a randomized comparison / assessment blind test
Region
| Japan |
Condition
Condition
Obsessive-compulsive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness of Guided Internet-based cognitive behavioral therapy for patients with obsessive-compulsive disorder
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Yale-Brown Obsessive-Compulsive Scale
Key secondary outcomes
Obsessive-Compulsive Inventory
Working Alliance Inventory-Short Form
EuroQol-5-Devison
Patient Health Questionnaire-9
Generalized Anxiety Disorder-7
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Guided internet cognitive behavioral therapy
Interventions/Control_2
Usual care
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for this study include being between 18 and 60 years old, having a primary diagnosis of OCD according to the Mini-International Neuropsychiatric Interview (M.I.N.I.) with the initially diagnosed OCD patients remaining symptomatic, having OCD that is at least moderate or higher in severity with a Yale-Brown Obsessive-Compulsive score of > 14, having skills to send e-mail, and having access to the e-learning system.
Key exclusion criteria
Participants with any of the following conditions will be excluded: psychosis, organic mental disorder, current high risk of suicide, substance abuse or dependence within the 12 months prior to enrollment, antisocial personality disorder, or unstable medical condition.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
260-8677
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Chiba University
Division name
Research center for child mental development
Zip code
260-8677
Address
1-8-1, Inohana, Chuouku, Chiba, Japan
TEL
043-226-2975
Homepage URL
axpa0219@chiba-u.jp
Sponsor or person
Institute
Research Center for Child Metnal Development, 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
University of Fukui
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University
Address
Research center for child mental development
Tel
0432262616
prc-jim@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
千葉大学医学部附属病院(千葉県)、福井大学医学部附属病院(福井県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
https://www.researchprotocols.org/2020/6/e18216
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
31
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 | 11 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As of July 31, 2020, 9 cases have been registered. Of these, 4 have completed the intervention or a waiting priod, and 5 are on the clinical trial. There are no reports of any adverse events at this time.
Management information
Registered date
| 2020 | Year | 02 | Month | 03 | Day |
Last modified on
| 2022 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044422
| 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 |
