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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013113
Receipt No. R000015301
Scientific Title The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,
Date of disclosure of the study information 2014/02/09
Last modified on 2015/08/09

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Basic information
Public title The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,
Acronym The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,
Scientific Title The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,
Scientific Title:Acronym The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,
Region
Japan

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

Objectives
Narrative objectives1 In this study, we examined the existence of regional structural abnormalities in both the gray matter (GM) and the white matter (WM) of patients with OCD at baseline using a voxel-based morphometry (VBM) approach in responders and non-responders to subsequent meta BT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The difference of regional structural abnormalities in both GM and WM at baseline using an optimized VBM approach in both responders and non-responders to meta-BT
Key secondary outcomes Neuropsychological tasks

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Meta 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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Japanese patients with OCD were recruited at Nagoya City University Hospital. 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
1st name
Middle name
Last name Shutaro Nakaaki
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8271
Email hzi05510@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiko Hashimoto
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8271
Homepage URL
Email hashinobu@nifty.com

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

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

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋市立大学大学院医学研究科 精神・認知・行動医学分野

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 09 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 Completed
Date of protocol fixation
2013 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 09 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 09 Day
Last modified on
2015 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015301

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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