UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044422