UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038085 |
|---|---|
| Receipt number | R000043320 |
| Scientific Title | An investigation into the efficacy of modulated CBT for patients with acquired brain injury suffering from anger management difficulties. -A multi-center randomized controlled trial. |
| Date of disclosure of the study information | 2019/09/24 |
| Last modified on | 2023/03/27 09:30:09 |
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Basic information
Public title
An investigation into the efficacy of modulated CBT for patients with acquired brain injury suffering from anger management difficulties. -A multi-center randomized controlled trial.
Acronym
An investigation into the efficacy of modulated CBT for patients with acquired brain injury suffering from anger management difficulties. -A multi-center randomized controlled trial.
Scientific Title
An investigation into the efficacy of modulated CBT for patients with acquired brain injury suffering from anger management difficulties. -A multi-center randomized controlled trial.
Scientific Title:Acronym
CBT-ABI project(RCT)
Region
| Japan |
Condition
Condition
acquired brain injury
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the clinical effectiveness of CBT on the difficulty of anger control for the patients with acquired brain injury as compared to talking control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
STAXI-2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Weekly or biweekly individual CBT (cognitive behavior therapy) over 3 months (8 sessions; those with the attendance rate of more than 80% of 8 sessions can be included for the analysis)
Interventions/Control_2
Weekly or biweekly individual talking control over 3 months (8 sessions; those with the attendance rate of more than 80% of 8 sessions can be included for the analysis)
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Those with clinically severe distress or functional disorders in terms of social, occupational or other significant aspects due to the difficulty of anger control
-Those with acquired brain injury more than half a year after the damageous event
-Those judged as capable of carrying out the required test or psychological intervention on the designated day after the informed consent
-Those with ability to both understand and agree with informed consent in Japanese
Key exclusion criteria
-Those under any treatment (or therapy is required) for substance-related disorders (except nicotine addiction)
-Those with too severe psychiatric or neurological disorders to attend the research
-Those with severe medical complication such as live dysfunction, renal dysfunction, endocrine disease
-Those ineligible to MRI implementation due to implanted metal in the body, tattoos or other reasons
-Those receiving any specific intensive psychotherapy including CBT elsewhere during the trial
-Those judged as no therapeutic indication of CBT by the researchers
-Strong suicidal ideation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mirai |
| Middle name | |
| Last name | So |
Organization
Tokyo Dental College
Division name
Department of Psychiatry, Ichikawa General Hospital
Zip code
272-8513
Address
5-11-13, Sugano,Ichikawa, Chiba, Japan
TEL
047-322-0151
ghh13250@gmail.com
Public contact
Name of contact person
| 1st name | Mirai |
| Middle name | |
| Last name | So |
Organization
Tokyo Dental College
Division name
Department of Psychiatry, Ichikawa General Hospital
Zip code
272-8513
Address
5-11-13, Sugano,Ichikawa, Chiba, Japan
TEL
047-322-0151
Homepage URL
somirai@tdc.ac.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Society for the Promotion of Science
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Radiological Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Hospital Clinical and Translational Research Center
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
keio@esct.bvits.com keio.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
慶應義塾大学病院、東京歯科大学市川病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2019 | Year | 09 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043320
| 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 |
