UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032975 |
|---|---|
| Receipt number | R000037183 |
| Scientific Title | Testing the efficacy of a comprehensive behavioral intervention for tics |
| Date of disclosure of the study information | 2018/06/14 |
| Last modified on | 2019/06/18 12:12:47 |
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Basic information
Public title
Testing the efficacy of a comprehensive behavioral intervention for tics
Acronym
Testing the efficacy of a comprehensive behavioral intervention for tics
Scientific Title
Testing the efficacy of a comprehensive behavioral intervention for tics
Scientific Title:Acronym
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
| 1st name | Yukiko |
| Middle name | |
| Last name | Kano |
Organization
the University of Tokyo
Division name
Department of Child Neuropsychiatry, Graduate School of Medicine, The University of Tokyo
Zip code
1138654
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL
0358008664
kano-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Matsuda |
Organization
the University of Tokyo
Division name
Department of Child Neuropsychiatry, Graduate School of Medicine, The University of Tokyo
Zip code
1138654
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL
0358008664
Homepage URL
mknatsumi-tky@umin.ac.jp
Sponsor or person
Institute
the University of Tokyo
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
The University of Tokyo, Graduate school of medicine
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 13 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037183
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
