UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006010 |
|---|---|
| Receipt number | 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 12:36:05 |
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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
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
mnonaka@p.u-tokyo.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007111
| 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 |
