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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038222
Receipt No. 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 2019/10/07

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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
Email 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
Email t-kick@nifty.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2020 Year 01 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
2019 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043573

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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