UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To explore both the neural basis of time estimation and the effect of cognitive -behavior therapy in obsessive compulsive disorder
Title of the study (Brief title)	The time estimation and cognitive -behavior therapy in obsessive compulsive disorder
Region	Japan

Condition
Condition	obsessive compulsive disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examined the effect of CBT using time estimation. We examined brain abnormalities in both the gray matter and the white matter of patients with OCD at baseline using brain MRI in responders and non responders to subsequent CBT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The effect of CBT
Key secondary outcomes	Brain MRI , Neuropsychological tasks

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom 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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Japanese patients with OCD were recruited. Diagnoses were made based on structured interviews conducted by trained psychiatrists using the Structured Clinical Interview for DSM-IV Patient Version (SCID-P).
Key exclusion criteria	There was a previous history of mental illness or substance abuse, the patient has pacemaker, other findings in terms with the aims of this study
Target sample size	40

Research contact person
Name of lead principal investigator	Shutaro Nakaaki
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
Address	Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL	052-853-8271
Email	hzi05510@gmail.com

Public contact
Name of contact person	Nobuhiko Hashimoto
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
Address	Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL	052-853-8271
Homepage URL
Email	hashinobu@nifty.com

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences,Department of Psychiatry and Cognitive-Behavioral Medicine
Institute
Department

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

Other related organizations
Co-sponsor	Yagoto Hospital
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 04 Month 24 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2016 Year 04 Month 24 Day
Last modified on	2017 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025408