UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038222 |
|---|---|
| Receipt number | R000043573 |
| Scientific Title | Cognitive Behavioral Therapy for Anger in Patients with Traumatic Brain Injury |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2020/12/14 20:11:55 |
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Basic information
Public title
Cognitive Behavioral Therapy for Anger in Patients with Traumatic Brain Injury
Acronym
CBT for TBI
Scientific Title
Cognitive Behavioral Therapy for Anger in Patients with Traumatic Brain Injury
Scientific Title:Acronym
CBT for TBI
Region
| Japan |
Condition
Condition
traumatic brain injury
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of group cognitive behavior therapy (CBT) focusing on anger control in patients with traumatic brain injury (TBI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement rate of State-Trait Anger Expression Inventory-II (STAXI-II) score among baseline and 0/3 months after treatment
Key secondary outcomes
Improvement rate of Patient Health Questionnaire-9, Generalized Anxiety Disorder 7-item, Quality of Life after Brain Injury, and Frontal Systems Behavior Scale amongbaseline and 0/3 months after treatment
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
Group cognitive behavioral therapy based on the manual focusing instantaneous and long-term control of anger, which is held 6 sessions of 90 minutes for 3-6 patients a week
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subject who meet all of the following conditions are eligible to participate in this study.
(1) 20 to 65 years old
(2) Subjects with traumatic brain injury due to head injury or organic brain diseases
(3) subjects feeling difficulties in management of anger
(4) Understand the purpose and content of this study and express written consent to participate in this study based on own will
Key exclusion criteria
Subjects with any of the following conditions are excluded from this study.
(1) History of psychotic disorders such as mood disorders, schizophrenia and alcohol / substance use disorders
(2) Subjects who will be impossible to continue visiting hospitals because of move and so on
(3) Subjects who have a life-threatening or unstable physical, brain, or mental illness in clinical diagnosis
(4) Subjects who have symptoms interfering with group psychotherapy, such as significant memory impairment, intellectual disability or suicidal idea/acts
(5) Others that the Principal Investigator has determined to be inappropriate for this research
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3971
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Kikuchi |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3971
Homepage URL
t-kick@nifty.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical and Translational Research Center
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 01 | 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
| 2019 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | 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
| 2019 | Year | 10 | Month | 07 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043573
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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