UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of cognitive behavior therapy for obsessive-compulsive disorder
Title of the study (Brief title)	Effectiveness of cognitive behavior therapy for obsessive-compulsive disorder
Region	Japan

Condition
Condition	Obsessive-compulsive disorder
Classification by specialty	Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effectiveness of cognitive behavioral therapy for Obsessive-compulsive disorder in Japanese clinical setting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Yale and Brown Obsessive-Compulsive Scale
Key secondary outcomes	OCI:Obsessive-Compulsive Inventory PHQ-9 GAD-7 SDS EQ-5D

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	18 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	Primary diagnosis of obsessive-compulsive disorder
Key exclusion criteria	Individual with who have histories of substance abuse, active sucidality, severe mental and physical condition, intelligence quotient < 80, Schizophrenia, Mood disorder, Antisocial Personality Disorder, Borderline Personality Disorder
Target sample size	10

Research contact person
Name of lead principal investigator	Akiko Nakagawa
Organization	Graduate School of Medicine, Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	043-226-2975
Email	akikon@chiba-u.jp

Public contact
Name of contact person	Masaru Kuno
Organization	Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	043-226-2975
Homepage URL
Email	m-kuno@chiba-u.jp

Sponsor
Institute	Research Center for Child Mental Development, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	千葉大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 12 Month 05 Day
Anticipated trial start date	2012 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 10 Day
Last modified on	2017 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013030