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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039375
Receipt No. 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 2020/08/04

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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
Email 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
Email axpa0219@chiba-u.jp

Sponsor
Institute Research Center for Child Metnal Development, Chiba University
Institute
Department

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
Email 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
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 Open public recruiting
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
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044422

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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