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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006010
Receipt No. R000007111
Scientific Title Examining the effectiveness of cognitive behavioral therapy for tic disorders
Date of disclosure of the study information 2011/07/20
Last modified on 2015/02/11

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Basic information
Public title Examining the effectiveness of cognitive behavioral therapy for tic disorders
Acronym Examining the effectiveness of cognitive behavioral therapy for tic disorders
Scientific Title Examining the effectiveness of cognitive behavioral therapy for tic disorders
Scientific Title:Acronym Examining the effectiveness of cognitive behavioral therapy for tic disorders
Region
Japan

Condition
Condition tic disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effectiveness of cognitive behavioral therapy for tic disorders and to clarify the factors related to treatment outcome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes tic symptoms of patients after 5 weeks and 10 weeks
Key secondary outcomes social functioning and Quality of Life of patients after 10 weeks

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
Behavior,custom
Interventions/Control_1 Comprehensive Behavioral Intervention for Tics
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
9 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.moderate or severe tic symptoms, measured by Yale Global Tic Severity Scale total score greater than 13(9 for patients with motor or vocal tics only)
Key exclusion criteria 1.IQ<75
2.severe comorbid symptoms
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukiko Kano
Organization The University of Tokyo, Graduate school of medicine
Division name Department of child neuropsychiatry
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Maiko Nonaka
Organization University of Tokyo Hospital
Division name Department of child psychiatry
Zip code
Address
TEL 03-5800-8664
Homepage URL
Email mnonaka@p.u-tokyo.ac.jp

Sponsor
Institute University of Tokyo Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.tandfonline.com/doi/abs/10.1080/02739615.2014.979922
Number of participants that the trial has enrolled
Results
Severity of tic symptoms, social impairment caused by tic, and subjective distress associated with tics were improved after intervention. However, premonitory urges measured by PUTS were not improved. 
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
2011 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2014 Year 07 Month 01 Day
Date of closure to data entry
2014 Year 09 Month 01 Day
Date trial data considered complete
2014 Year 09 Month 01 Day
Date analysis concluded
2014 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 20 Day
Last modified on
2015 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007111

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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