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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032975
Receipt No. R000037183
Official scientific title of the study Testing the efficacy of a comprehensive behavioral intervention for tics
Date of disclosure of the study information 2018/06/14
Last modified on 2018/06/13

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Basic information
Official scientific title of the study Testing the efficacy of a comprehensive behavioral intervention for tics
Title of the study (Brief title) Testing the efficacy of a comprehensive behavioral intervention for tics
Region
Japan

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

Objectives
Narrative objectives1 To test 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 rated by YGTSS in pre-session assessment, session 6 and 9
Key secondary outcomes anxiety, premonitory urge, tic suppression ability (rated in pre-session assessment, session 6 and 9)
social functioning, QOL (rated in pre-session assessment, session 9)

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Comprehensive Behavior Interventions for Tics:
9 session, 11 weeks, including psycho-education, functional analysis, relaxation and HRV biofeedback. During HRT training, we will use electromyograph biofeedback(Nihon-Koden MEM-8301 Neuropack n1)
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
60 years-old >=
Gender Male and Female
Key inclusion criteria having a persistent motor or vocal tic disorders or Tourette's disorders
Key exclusion criteria mental retardation, under 13 in YGTSS symptom score (Under 9 score in YGTSS symptoms score when patients have an only motor or vocal tics), severe major depression, psychotic disorder or other comorbid symptoms that disturbs treating tics
Target sample size 20

Research contact person
Name of lead principal investigator Kano Yukiko
Organization the University of Tokyo
Division name Department of Child Neuropsychiatry, Graduate School of Medicine, The University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL 0358008664
Email kano-tky@umin.ac.jp

Public contact
Name of contact person Matsuda Natsumi
Organization the University of Tokyo
Division name Department of Child Neuropsychiatry, Graduate School of Medicine, The University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL 0358008664
Homepage URL
Email mknatsumi-tky@umin.ac.jp

Sponsor
Institute the University of Tokyo
Institute
Department

Funding Source
Organization Grant-in-Aid for JSPS Fellows, Grant-in-Aid for Young Scientiststs (B)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 東京大学こころの発達診療部

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 14 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 18 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
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037183

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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