UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000028209
Receipt No. R000032289
Scientific Title A randomized controlled trial of a Cognitive Behavioral Intervention for Anger Management
Date of disclosure of the study information 2020/04/01
Last modified on 2020/07/15 (Ver. 5)

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Basic information
Public title A randomized controlled trial of a Cognitive Behavioral Intervention for Anger Management
Acronym CBT for Anger Management
Scientific Title A randomized controlled trial of a Cognitive Behavioral Intervention for Anger Management
Scientific Title:Acronym CBT for Anger Management
Region
Japan

Condition
Condition healthy person
Classification by specialty
Not applicable Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 (1)the construction of CBT based group sessions for anger
(2)the effects of this program on the anger outcomes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes STAXI(State-Trait Anger Expression Inventory)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Eight group 40-minutes sessions about anger problems (Intervention Group)
Interventions/Control_2 Eight group 40-minutes sessions excluding anger problems (Control Group)
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Undergraduates
(2)The signature on the letter of consent
Key exclusion criteria None
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Katsutoshi
Middle name
Last name Tanaka
Organization Kitasato University Graduate School of Medical Sciences
Division name Kitasato University Graduate School of Medical Sciences
Zip code 252-0373
Address 1-15-1 Kitasato, Sagamihara-Shi, Kanagawa, 252-0373, Japan
TEL 042-778-7962
Email k-tanaka@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Katsutoshi
Middle name
Last name Tanaka
Organization Kitasato University Graduate School of Medical Sciences
Division name Department of Medical Science
Zip code 252-0373
Address 1-15-1 Kitasato, Sagamihara-Shi, Kanagawa, 252-0373, Japan
TEL 042-778-7962
Homepage URL
Email k-tanaka@kitasato-u.ac.jp

Sponsor
Institute Kitasato University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitasato University Graduate School of Medical Sciences
Address 1-15-1 Kitasato, Sagamihara-Shi, Kanagawa, 252-0373, Japan
Tel 042-778-9603
Email matsunao@kitasato-u.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
2020 Year 04 Month 01 Day

Related information
URL releasing protocol http://mlib.kitasato-u.ac.jp/homepage/ktms/kaishi/pdf/KMJ50-1/KMJ50-1.html
Publication of results Published

Result
URL related to results and publications http://mlib.kitasato-u.ac.jp/homepage/ktms/kaishi/pdf/KMJ50-1/KMJ50-1.html
Number of participants that the trial has enrolled 179
Results 
 It was clarified that all variables had a large effect immediately after the completion of the program. 
Urthermore, it was clarified that the effect was strong in 4 subscales, but not in Anger Control, at 5-6 weeks after the completion of the program. Also, the tendency to keep anger from showing was found to be slightly affected. Therefore, the results show that the effects of this program lasted for up to 5-6 weeks after the completion of the program.
Results date posted
2020 Year 07 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
university student
Participant flow 
To convey the purpose of the study, all participants received an explanation of the research outline, purpose, and various matters concerning the protection of personal information, and written consent for participation in the study was obtained from each participant. We randomly assigned participants to the intervention group and the control group using the permuted block method (block size = 2) for 179 students.
Adverse events 
None
Outcome measures 
STAXI
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
2017 Year 05 Month 29 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2018 Year 01 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
2017 Year 07 Month 13 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032289