UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048440 |
|---|---|
| Receipt number | R000055185 |
| Scientific Title | A Multi-Institutional Randomized Controlled Trial of a Remote Administration and Group Setting Comprehensive Behavioral Intervention for Tics |
| Date of disclosure of the study information | 2022/07/23 |
| Last modified on | 2023/08/25 16:30:30 |
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Basic information
Public title
A Multi-Institutional Randomized Controlled Trial of a Remote Administration and Group Setting Comprehensive Behavioral Intervention for Tics
Acronym
A Multi-Institutional Randomized Controlled Trial of a Remote Administration and Group Setting Comprehensive Behavioral Intervention for Tics
Scientific Title
A Multi-Institutional Randomized Controlled Trial of a Remote Administration and Group Setting Comprehensive Behavioral Intervention for Tics
Scientific Title:Acronym
RCT of Remote Group CBIT
Region
| Japan |
Condition
Condition
Tic disorder/Tourette syndrome
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the efficacy and safety of a Remote Administration and Group Setting Comprehensive Behavioral Intervention for Tics (CBIT)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
YGTSS (pre, post, 1 month later, 6 month later, 1 year later)
Key secondary outcomes
CGI-S, CGI-I, SUDS, PUTS, PGI-I, PTQ
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Remote Administration and Group Setting CBIT
Interventions/Control_2
Remote and group CBIT follows the CBIT manual developed by Woods and colleagues in terms of number and components of treatment sessions, distribution of CBIT contents, and length of intervention.
Interventions/Control_3
Participants attend each session in groups of four.
Each session last approximately 60 minutes.
Sessions are conducted remotely using a web conferencing system (Zoom).
Sessions are conducted by two clinical psychologists (a session leader and a support).
Sessions 1-8 will be conducted weekly, following Session 9 held 3-4 weeks later.
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
| 7 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who visited a institution by March 31, 2023
2) Diagnosis of tic disorder (chronic tic or Tourette's) according to DSM-5 diagnostic criteria
3) CGI-S score between 4 to 6
4) Patients with no change in treatment for more than 6 weeks
5) Patients with a PC or tablet at home and a communication environment that allows use of Zoom
6) Patients for whom written consent can be obtained from the individual and his/her guardian
Key exclusion criteria
1) Patients with other psychiatric disorders except ADHD and mild OCD , abused children, and patients with severe physical illness
2) Patients with an IQ below 85 on the most recent intelligence test (WISC-IV)
3) Patients who are deemed ineligible by the physician in charge
4) Patients who have received Habit Reversal Method or CBIT in the past
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Inoue |
Organization
Dokkyo Medical university Saitama Medical Center
Division name
Child Development and Psychosomatic Medicine Center
Zip code
343-8555
Address
2-1-50 Minami-Koshigaya, Koshigaya-shi, Saitama, 343-8555 Japan
TEL
048-965-1111
tinoue@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Inoue |
Organization
Dokkyo Medical university Saitama Medical Center
Division name
Child Development and Psychosomatic Medicine Center
Zip code
343-8555
Address
2-1-50 Minami-Koshigaya, Koshigaya-shi, Saitama, 343-8555 Japan
TEL
048-965-1111
Homepage URL
tinoue@dokkyomed.ac.jp
Sponsor or person
Institute
Child Development and Psychosomatic Medicine Center Dokkyo Medical university Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
THE UNIVERS FOUNATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethical Committee of Dokkyo Medical University Saitama Medical Center
Address
2-1-50 Minami-Koshigaya, Koshigaya-shi, Saitama, 343-8555 Japan
Tel
048-965-1111
tinoue@dokkyomed.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 07 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055185
| Research Plan | |
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| 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 |
